Trial Outcomes & Findings for High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (NCT NCT03945591)
NCT ID: NCT03945591
Last Updated: 2026-04-23
Results Overview
Rate of acute GvHD post-transplant. All participants that received a transplant and received any prophylactic treatment will be included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Day 120 Post-Transplant
Results posted on
2026-04-23
Participant Flow
23 participants were consented. 2 of these participants did not initiate the study.
Participant milestones
| Measure |
Cyclophosphamide and Bortezomib
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Cyclophosphamide and Bortezomib
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Overall Study
Participant not transplanted
|
1
|
|
Overall Study
Change in treatment plan
|
3
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Baseline characteristics by cohort
| Measure |
Cyclophosphamide and Bortezomib
n=16 Participants
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Age, Continuous
|
63 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Day 120 Post-TransplantRate of acute GvHD post-transplant. All participants that received a transplant and received any prophylactic treatment will be included in the analysis.
Outcome measures
| Measure |
Cyclophosphamide and Bortezomib
n=13 Participants
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Percentage of Participants Who Experience Acute GvHD
|
38.46 percentage of participants
Interval 22.0 to 47.0
|
PRIMARY outcome
Timeframe: Day 365 Post-TransplantRate of chronic GvHD post-transplant. All participants that received a transplant and received any prophylactic treatment will be included in the analysis.
Outcome measures
| Measure |
Cyclophosphamide and Bortezomib
n=11 Participants
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Percentage of Participants Who Experience Moderate to Severe Chronic GvHD
|
36.36 percentage of participants
Interval 22.0 to 46.0
|
SECONDARY outcome
Timeframe: Day 45 Post-TransplantIncidence of graft failure will be calculated from date of transplant to failure for all patients who receive a transplant and any prophylactic treatment and from date of completion of prophylactic treatment for all participants that completed treatment. Graft failure is defined as failure to achieve neutrophil engraftment by day 28 post-transplant or lack of donor chimerism \> 50% by day 45 post-transplant not due to the underlying malignancy.
Outcome measures
| Measure |
Cyclophosphamide and Bortezomib
n=16 Participants
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Incidence of Primary Graft Failure
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 30 Post-TransplantIncidence of poor graft function will be calculated from date of transplant to failure for all patients who receive a transplant and any prophylactic treatment and from date of completion of prophylactic treatment for all participants that completed treatment. Poor graft function is defined by at least 2 of the following 3 criteria: Hemoglobin \< 8 g/dL, ANC \< 0.5 109/L, and platelets \< 20 109/L. The cytopenia must be unexplained (such as by disease relapse) and unresponsive to cytokines and must last at least 4 weeks.
Outcome measures
| Measure |
Cyclophosphamide and Bortezomib
n=16 Participants
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Incidence of Poor Graft Function
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 730 Post-TransplantIncidence of secondary graft failure is evaluated after engraftment is achieved; this outcome is calculated from date of engraftment for all patients with engraftment. Secondary graft failure is defined as poor graft function associated with donor chimerism \< 5%.
Outcome measures
| Measure |
Cyclophosphamide and Bortezomib
n=16 Participants
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Incidence of Secondary Graft Failure
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 730 Post-TransplantNumber of participant deaths not attributable to disease relapse or progression . This outcome is analyzed based on participants that who received a transplant with any prophylactic treatment and for all patients who received a transplant and completed prophylactic treatment.
Outcome measures
| Measure |
Cyclophosphamide and Bortezomib
n=16 Participants
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Treatment Related Mortality (TRM)
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 730 Post-TransplantPercentage of participants in whom the disease for which transplant is performed is evident by methods of disease detection after transplant. This outcome is analyzed for all patients who received a transplant and for all transplanted patients that completed treatment.
Outcome measures
| Measure |
Cyclophosphamide and Bortezomib
n=16 Participants
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Relapse Rate (RR)
|
12.50 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 730 Post-TransplantPercentage of participants who are without reported GvHD III-IV acute GvHD, chronic GvHD requiring systemic therapy and have not experienced relapse or death after transplant.
Outcome measures
| Measure |
Cyclophosphamide and Bortezomib
n=16 Participants
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Graft Versus Host Disease Relapse Free Survival (GRFS)
|
62.50 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 730 Post-TransplantPercentage of participants alive at the end of the study's evaluation period.
Outcome measures
| Measure |
Cyclophosphamide and Bortezomib
n=16 Participants
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Overall Survival (OS)
|
87.50 Percentage of participants
|
Adverse Events
Cyclophosphamide and Bortezomib
Serious events: 7 serious events
Other events: 10 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cyclophosphamide and Bortezomib
n=16 participants at risk
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
18.8%
3/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
4/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Ascites
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Investigations
Blood Bilirubin Increased
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
Cytomegalovirus Infection Reactivation
|
18.8%
3/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
General disorders
Death
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
General disorders
Fever
|
25.0%
4/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
COVID Infection
|
18.8%
3/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
BK Viremia
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
Adenovirus
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Blood and lymphatic system disorders
Methemoglobinemia
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Nervous system disorders
Syncope
|
25.0%
4/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
Other adverse events
| Measure |
Cyclophosphamide and Bortezomib
n=16 participants at risk
Bortezomib: 1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
Cyclophosphamide: 50 mg/kg IV over 2 hours on Day +3 and +4
|
|---|---|
|
Psychiatric disorders
Agitation
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Investigations
Alanine Aminotransferase Increased
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Investigations
Alkaline Phosphatase Increased
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Cardiac disorders
Atrial Fibrillation
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
Bacteremia
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Renal and urinary disorders
Hematuria
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.8%
3/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
Hypoxia
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
C. Difficile
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Mucositis Oral
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
General disorders
Pain
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Investigations
Platelet Count Decreased
|
25.0%
4/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
2/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Secretions
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Cardiac disorders
Sinus Tachycardia
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
Urinary Tract Infection
|
18.8%
3/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Infections and infestations
Viremia
|
18.8%
3/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Adverse events assessed from the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total). All-cause mortality assessed through day 730 Post-Transplant.
Investigator assessment at each study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place