Trial Outcomes & Findings for Belimumab for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation (NCT NCT03207958)
NCT ID: NCT03207958
Last Updated: 2026-04-20
Results Overview
* Adverse events were graded according to CTCAE v4.03. * All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
From start of treatment through 30 days following the completion of treatment (median length of follow-up 205 days, full range 56-229 days)
Results posted on
2026-04-20
Participant Flow
Participant milestones
| Measure |
Belimumab
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Belimumab
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Relapsed lymphoma
|
1
|
Baseline Characteristics
Belimumab for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation
Baseline characteristics by cohort
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Age, Continuous
|
55.5 years
n=129 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=129 Participants
|
PRIMARY outcome
Timeframe: From start of treatment through 30 days following the completion of treatment (median length of follow-up 205 days, full range 56-229 days)* Adverse events were graded according to CTCAE v4.03. * All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
Outcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 2 confusion
|
1 Participants
|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 1 rash maculo-papular
|
1 Participants
|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 2 alanine aminotransferase increased
|
1 Participants
|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 1 alkaline phosphatase increased
|
1 Participants
|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 1 aspartate aminotransferase increased
|
1 Participants
|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 3 lymphocyte count decreased
|
3 Participants
|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 3 platelet count decreased
|
1 Participants
|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 3 hyponatremia
|
1 Participants
|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 2 eye pain
|
1 Participants
|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 1 diarrhea
|
1 Participants
|
|
Safety and Tolerability of Belimumab as Prophylaxis of Chronic GvHD in Subjects Following alloHCT as Measured by Number of Participants Who Experience Each Adverse Event
Grade 3 facial pain
|
1 Participants
|
SECONDARY outcome
Timeframe: Cycle 3 (each cycle is 4 weeks), Cycle 4, Cycle 5, Cycle 6, Cycle 7, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, and 24 months-The presence of chronic GvHD will be determined according to the 2014 NIH Criteria. If chronic GvHD is diagnosed, each organ will be scored 0-3 and graded, according to the 2014 NIH criteria for Diagnosing and Staging of Chronic GvHD. These data will allow calculation of the NIH global severity score of mild, moderate or severe.
Outcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Incidence and Severity of Chronic GvHD
Cycle 3 · None
|
9 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 3 · Mild
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 3 · Moderate
|
1 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 3 · Severe
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 4 · None
|
10 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 4 · Mild
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 4 · Moderate
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 4 · Severe
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 5 · None
|
10 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 5 · Mild
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 5 · Moderate
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 5 · Severe
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 6 · None
|
9 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 6 · Mild
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 6 · Moderate
|
1 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 6 · Severe
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 7 · None
|
10 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 7 · Mild
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 7 · Moderate
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
Cycle 7 · Severe
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
6 months · None
|
10 Participants
|
|
Incidence and Severity of Chronic GvHD
6 months · Mild
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
6 months · Moderate
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
6 months · Severe
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
9 months · None
|
10 Participants
|
|
Incidence and Severity of Chronic GvHD
9 months · Mild
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
9 months · Moderate
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
9 months · Severe
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
12 months · None
|
7 Participants
|
|
Incidence and Severity of Chronic GvHD
12 months · Mild
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
12 months · Moderate
|
2 Participants
|
|
Incidence and Severity of Chronic GvHD
12 months · Severe
|
1 Participants
|
|
Incidence and Severity of Chronic GvHD
15 months · None
|
7 Participants
|
|
Incidence and Severity of Chronic GvHD
15 months · Mild
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
15 months · Moderate
|
2 Participants
|
|
Incidence and Severity of Chronic GvHD
15 months · Severe
|
1 Participants
|
|
Incidence and Severity of Chronic GvHD
18 months · None
|
8 Participants
|
|
Incidence and Severity of Chronic GvHD
18 months · Mild
|
1 Participants
|
|
Incidence and Severity of Chronic GvHD
18 months · Moderate
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
18 months · Severe
|
1 Participants
|
|
Incidence and Severity of Chronic GvHD
21 months · None
|
9 Participants
|
|
Incidence and Severity of Chronic GvHD
21 months · Mild
|
1 Participants
|
|
Incidence and Severity of Chronic GvHD
21 months · Moderate
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
21 months · Severe
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
24 months · None
|
10 Participants
|
|
Incidence and Severity of Chronic GvHD
24 months · Mild
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
24 months · Moderate
|
0 Participants
|
|
Incidence and Severity of Chronic GvHD
24 months · Severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 3 (each cycle is 4 weeks), Cycle 4, Cycle 5, Cycle 6, Cycle 7, and 6 months* Acute GvHD staging has 4 organ systems: skin, lower gastrointestinal (GI), upper GI, and liver. * Skin (% body surface area): stage 0 no rash, stage 1 \< 25%, stage 2 25%-50%, stage 3 \>50%, stage 4 generalized erythroderma with bullae * Lower GI (diarrhea, mL/day): stage 0 \<500, stage 1 \>500, stage 2 \>1000, stage 3 \>1500, stage 4 severe abdominal pain +/- ileus * Upper GI: only stage is stage 1 which is persistent, severe nausea * Liver (bilirubin, mg/dL): stage 0 ≥2, stage 1 2.1-3, stage 2 3.1-6, stage 3 6.1-15, stage 4 \>15 * Acute GvHD will be graded according to modified Minnesota grading scale. Organ systems are broken down into skin, liver, lower gastrointestinal (GI), and upper gastrointestinal (GI) and the grades are I, II, III, IV. * I: skin stage 1-2, liver/lower GI/upper GI stage 0 * II: skin stage 3, liver/lower GI/upper GI stage 1 * III: liver stage 2-4, lower GI stage 2-3 * IV: skin stage 4, lowr GI stage 4 Grade IV is t
Outcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Incidence and Severity of Acute GvHD
Cycle 3 · None
|
9 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 3 · Grade I
|
1 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 3 · Grade II
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 3 · Grade III
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 3 · Grade IV
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 4 · None
|
10 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 4 · Grade I
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 4 · Grade II
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 4 · Grade III
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 4 · Grade IV
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 5 · None
|
10 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 5 · Grade I
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 5 · Grade II
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 5 · Grade III
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 5 · Grade IV
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 6 · None
|
10 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 6 · Grade I
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 6 · Grade II
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 6 · Grade III
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 6 · Grade IV
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 7 · None
|
10 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 7 · Grade I
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 7 · Grade II
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 7 · Grade III
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
Cycle 7 · Grade IV
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
6 months · None
|
10 Participants
|
|
Incidence and Severity of Acute GvHD
6 months · Grade I
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
6 months · Grade II
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
6 months · Grade III
|
0 Participants
|
|
Incidence and Severity of Acute GvHD
6 months · Grade IV
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, and 24 months after alloHCT-Overall survival will be determined from date of belimumab initiation, with death from any cause as the event of interest, and censoring at last follow up date for those with incomplete observations.
Outcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Overall Survival
6 months
|
10 Participants
|
|
Overall Survival
12 months
|
10 Participants
|
|
Overall Survival
24 months
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 months, 8 months, 12 months, and 24 months post-alloHCTPopulation: Two patients relapsed at 8 months which is why they are not included at 12 and 24 months.
Outcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Relapse Rate
6 months
|
0 Participants
|
|
Relapse Rate
8 months
|
2 Participants
|
|
Relapse Rate
12 months
|
0 Participants
|
|
Relapse Rate
24 months
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months after alloHCTOutcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Overall Corticosteroid Requirement for Treatment of Chronic GvHD
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 months after alloHCTOutcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Overall Corticosteroid Requirement for Treatment of Chronic GvHD
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 months after alloHCTOutcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Overall Corticosteroid Requirement for Treatment of Chronic GvHD
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 months after alloHCT-The use of additional systemic immune suppressive agents will be captured at each study visit.
Outcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Number of Participants That Required Alternative Treatment Modalities for Chronic GvHD
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 months after alloHCT-The use of additional systemic immune suppressive agents will be captured at each study visit.
Outcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Number of Participants That Required Alternative Treatment Modalities for Chronic GvHD
|
2 Participants
|
SECONDARY outcome
Timeframe: 24 months after alloHCT-The use of additional systemic immune suppressive agents will be captured at each study visit.
Outcome measures
| Measure |
Belimumab
n=10 Participants
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Number of Participants That Required Alternative Treatment Modalities for Chronic GvHD
|
1 Participants
|
Adverse Events
Belimumab
Serious events: 1 serious events
Other events: 5 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Belimumab
n=10 participants at risk
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
|
Psychiatric disorders
Confusion
|
10.0%
1/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
Other adverse events
| Measure |
Belimumab
n=10 participants at risk
* Subjects meeting eligibility criteria will start treatment between Day +30 and Day +80 after alloHCT
* Belimumab will be administered intravenously every 2 weeks for 3 doses followed by 4 doses at monthly intervals, for a total of 7 doses (6 months)
|
|---|---|
|
Eye disorders
Eye pain
|
10.0%
1/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
|
General disorders
Facial pain
|
10.0%
1/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
1/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
|
Investigations
Lymphocyte count decreased
|
30.0%
3/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
|
Investigations
Platelet count decreased
|
10.0%
1/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
1/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
1/10 • - Adverse events (AEs) and serious adverse events (SAEs) were collected from start of treatment through 30 days following the last day of study treatment (median length of follow-up 205 days, full range 56-229 days). - All-cause mortality was collected through completion of follow-up (up to 2 years after completion of treatment).
\- All adverse events were collected with the exception of: * Adverse events that are less than CTCAE grade 3 unless the AE met the definition of a serious adverse event. * Adverse events not of special interest as defined in the protocol (special interest AEs will be recorded regardless of grade, including those thought to be related to chronic GvHD)
|
Additional Information
Dr. Iskra Pusic
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place