Trial Outcomes & Findings for Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (NCT NCT03399773)
NCT ID: NCT03399773
Last Updated: 2026-07-10
Results Overview
Primary graft failure/rejection as defined by no neutrophil recovery (regardless of donor chimerism) or autologous recovery (neutrophil recovery but \< 10% donor chimerism in blood and bone marrow \[BM\]).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Up to day 45 post-transplant
Results posted on
2026-07-10
Participant Flow
Patients were recruited at the Fred Hutchinson Cancer Center (FHCC) Bone Marrow Transplant (BMT) during routine transplant evaluation. Patients eligible for umbilical cord blood transplant and meeting study criteria were invited to participate. Screening typically occurred within approximately 30 days. Eligible patients provided informed consent and were enrolled by FHCC BMT physicians.
Participant milestones
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
Study Treatment
|
7
|
9
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Overall Study
On Study Follow-Up (<2 years post-transplant)
|
7
|
5
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Relapse Requiring Alternative Therapy
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=16 Participants
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=15 Participants
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
27 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Disease Diagnosis
Acute Myeloid Leukemia (AML)
|
7 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
|
Disease Diagnosis
Biphenotypic Acute Leukemia (BAL) or Mixed-Lineage Leukemia (MPAL)
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Disease Diagnosis
Acute Lymphoblastic Leukemia (ALL)
|
7 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
12 Participants
n=267 Participants
|
|
Disease Diagnosis
Myelodysplasia (MDS)
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Disease Diagnosis
Chronic Myeloid Leukemia (CML)
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Comorbidity Score
0
|
7 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Comorbidity Score
1
|
2 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Comorbidity Score
2
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Comorbidity Score
3
|
6 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Comorbidity Score
4
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Comorbidity Score
5
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Donor/graft characteristics
Fully matched, 6/6
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Donor/graft characteristics
Single mismatch, 5/6
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Donor/graft characteristics
Two mismatches, 4/6
|
14 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
25 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Up to day 45 post-transplantPopulation: Participants who did not proceed to transplant on the study were not analyzed.
Primary graft failure/rejection as defined by no neutrophil recovery (regardless of donor chimerism) or autologous recovery (neutrophil recovery but \< 10% donor chimerism in blood and bone marrow \[BM\]).
Outcome measures
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Number of Participants With Graft Failure
Engrafted
|
14 Participants
|
14 Participants
|
|
Number of Participants With Graft Failure
Graft failure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study product infusion start through day 100 post-transplantAdverse events (AEs) were graded using the CTCAE v5.0. This outcome measured the number of participants who experienced at least one grade ≥ 3 adverse event considered related to the study product during the period of start of infusion of the study product (Day 0) until 100 days following transplant. An AE is considered related to the study product based on investigator assessment if it was assessed as definitely, probably, or possibly related; unrelated if it is assessed as unlikely related or unrelated. AE severity grade, seriousness, and relatedness were evaluated independently; therefore, grade ≥3 events were not necessarily serious adverse events (SAEs). Reporting of grade ≥3 AEs and all-grade SAEs is provided in the Adverse Events module. Dose-limiting toxicities (DLTs) were predefined.
Outcome measures
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=16 Participants
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=15 Participants
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Number of Participants Who Experienced Grade ≥3 Adverse Events Related to Study Product
|
15 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to day 45 post-transplantPopulation: Participants who did not proceed to transplant on the study were not analyzed.
The day of neutrophil recovery will be the 1st day of 2 consecutive days of absolute neutrophil count at or above 500 after the 1st post-cord blood transplant nadir.
Outcome measures
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Time to Neutrophil Engraftment
|
18 days
Interval 15.0 to 30.0
|
18 days
Interval 14.0 to 27.0
|
SECONDARY outcome
Timeframe: Up to day 100 post-transplantPopulation: Participants who did not proceed to transplant on the study were not analyzed.
Measured by the number of participants with a platelet count \> 20,000/ul without subsequent transfusions for 7 days. Participants who did not reach platelet engraftment by day 100 post-transplant were censored at day 100.
Outcome measures
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Time to Platelet Engraftment
|
30 days
Interval 26.0 to 43.0
|
31 days
Interval 23.0 to 42.0
|
SECONDARY outcome
Timeframe: At day 100 post-transplantPopulation: Participants who did not proceed to transplant on the study or were off-studied for any reason prior to 100 day post-transplant assessment were not analyzed.
The presence of aGVHD was assessed using the Acute GVHD Grading Scale and represented as overall grade I-IV, with higher grade indicating worse outcomes. Grade I aGVHD is defined as skin stage 1-2 and stage 0 for both GI and liver. Grade II is stage 3 skin, stage 1 GI, or stage 1 liver. Grade III is stage 4 skin or stage 2-4 GI or stage 2-4 liver, without GVHD as a major contributing cause of death. Grade IV is stage 4 skin or stage 2-4 GI or stage 2-4 liver, with GVHD as a major contributing cause of death.
Outcome measures
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=13 Participants
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Number of Participants With Acute Graft Versus Host Disease (aGVHD), by Grade
Grade I
|
0 Participants
|
2 Participants
|
|
Number of Participants With Acute Graft Versus Host Disease (aGVHD), by Grade
Grade II
|
13 Participants
|
7 Participants
|
|
Number of Participants With Acute Graft Versus Host Disease (aGVHD), by Grade
Grade III
|
0 Participants
|
0 Participants
|
|
Number of Participants With Acute Graft Versus Host Disease (aGVHD), by Grade
Grade IV
|
0 Participants
|
0 Participants
|
|
Number of Participants With Acute Graft Versus Host Disease (aGVHD), by Grade
No aGVHD
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 year post-transplantPopulation: Participants who did not proceed to transplant on the study, were off-studied for any reason prior to 1 year post-transplant, or for which the 1 year evaluation was missed were not analyzed. Participants who are on active follow-up are not yet included in this analysis.
The presence of cGVHD was assessed using the Chronic GVHD Grading Scale, with higher severity indicating worse outcomes. Incidence of moderate or severe cGVHD were considered clinically significant. Mild cGVHD is defined as limited organ involvement with minimal functional impairment, typically affecting 1-2 organs/sites with no major impact on daily activities. Moderate cGVHD is indicated by more extensive organ involvement and/or clinically significant functional impairment, but without major disability. Severe cGVHD is defined as major organ involvement with substantial functional impairment or disability, often requiring intensive systemic therapy. Abnormalities that could indicate cGVHD are reviewed for the following organ systems: skin, nails, hair, mouth, eyes, vagina/vulva (for female patients), liver, lung, GI, fasciitis, serositis, muscle, skeletal.
Outcome measures
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=11 Participants
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=9 Participants
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Number of Participants With Chronic Graft Versus Host Disease (cGVHD), by Severity
Mild
|
2 Participants
|
2 Participants
|
|
Number of Participants With Chronic Graft Versus Host Disease (cGVHD), by Severity
Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chronic Graft Versus Host Disease (cGVHD), by Severity
Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chronic Graft Versus Host Disease (cGVHD), by Severity
No cGVHD
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years post-transplantThe presence of cGVHD was assessed using the Chronic GVHD Grading Scale, with higher severity indicating worse outcomes. Incidence of moderate or severe cGVHD were considered clinically significant. Mild cGVHD is defined as limited organ involvement with minimal functional impairment, typically affecting 1-2 organs/sites with no major impact on daily activities. Moderate cGVHD is indicated by more extensive organ involvement and/or clinically significant functional impairment, but without major disability. Severe cGVHD is defined as major organ involvement with substantial functional impairment or disability, often requiring intensive systemic therapy. Abnormalities that could indicate cGVHD are reviewed for the following organ systems: skin, nails, hair, mouth, eyes, vagina/vulva (for female patients), liver, lung, GI, fasciitis, serositis, muscle, skeletal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At day 100 post-transplantPopulation: Participants who did not proceed to transplant on the study were not analyzed.
Non-relapse mortality (NRM) is defined as death without a prior relapse.
Outcome measures
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Number of Participants Who Experienced Non-relapse Mortality
Experienced non-relapse mortality
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Non-relapse Mortality
Did not experience non-relapse mortality
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: At day 180 post-transplantPopulation: Participants who did not proceed to transplant on the study were not analyzed.
Non-relapse mortality (NRM) is defined as death without a prior relapse.
Outcome measures
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=14 Participants
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Number of Participants Who Experienced Non-relapse Mortality
Experienced non-relapse mortality
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Experienced Non-relapse Mortality
Did not experience non-relapse mortality
|
14 Participants
|
13 Participants
|
Adverse Events
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
Serious events: 8 serious events
Other events: 16 other events
Deaths: 0 deaths
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
Serious events: 7 serious events
Other events: 14 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=16 participants at risk
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=15 participants at risk
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Renal and urinary disorders
Abdominal pain
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Disseminated adenovirus (ADV)
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Encephalitis infection
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
General disorders
Fever
|
18.8%
3/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Foodborne gastroenteritis
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
2/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Malabsorption
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Nervous system disorders
Seizure
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Nervous system disorders
Syncope
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar hemorrhage (DAH)
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
Other adverse events
| Measure |
Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel
n=16 participants at risk
Participants (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Participants undergo TBI BID on days -4 to -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel
n=15 participants at risk
Participants (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Participants undergo TBI QD on days -2 and -1. Participants receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
|
|---|---|---|
|
Gastrointestinal disorders
Anal fistula
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
3/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
13.3%
2/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
20.0%
3/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Investigations
Alanine aminotransferase (ALT) increased
|
12.5%
2/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.8%
3/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
53.3%
8/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Investigations
Aspartate aminotransferase (AST) increased
|
12.5%
2/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Cytomegalovirus (CMV) infection reactivation
|
18.8%
3/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Enterocolitis infectious
|
18.8%
3/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
33.3%
5/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Esophageal mucositis
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
General disorders
Fatigue
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
13.3%
2/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
81.2%
13/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
73.3%
11/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
General disorders
Fever
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Fungemia
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Psychiatric disorders
Hallucinations
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Renal and urinary disorders
Hematuria
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
13.3%
2/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
2/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemic respiratory failure
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Lung infection
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Malnutrition
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Mucositis oral
|
37.5%
6/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
20.0%
3/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
13.3%
2/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Parotid gland swelling
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
31.2%
5/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
26.7%
4/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Rectal pain
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Sepsis
|
18.8%
3/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
13.3%
2/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Cardiac disorders
Sinus bradycardia
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Skin infection
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Nervous system disorders
Syncope
|
18.8%
3/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy (TMA)
|
0.00%
0/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
6.7%
1/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
2/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
20.0%
3/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
|
Gastrointestinal disorders
Weigh loss
|
6.2%
1/16 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
0.00%
0/15 • AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.
AEs were graded in severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Grade ≥ 3 adverse events (or highly unusual grade 2 AEs) and all grade serious AEs (SAEs) were recorded, regardless of relationship to the study product or transplant. Participants included in the secondary outcome measure evaluating study product-related Grade ≥3 AEs are represented within this Adverse Events module, but not necessarily exclusively within the SAE table.
|
Additional Information
Filippo Milano, MD, PhD; Associate Professor
Fred Hutchinson Cancer Center
Phone: 2066675925
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place