Trial Outcomes & Findings for Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers (NCT NCT01135329)
NCT ID: NCT01135329
Last Updated: 2018-07-03
Results Overview
Percentage of participants achieving full-donor chimerism in unsorted peripheral blood.
TERMINATED
PHASE2
15 participants
Day 60
2018-07-03
Participant Flow
Participant milestones
| Measure |
BMT Allogenic Transplantation
Fludarabine, Busulfan, Cyclophosphamide, Tacrolimus,: Fludarabine 30 mg/m2 IV once a day for 4 days Busulfan 0.8 mg/kg IV every 12 hours for 4 days Cyclophosphamide 50 mg/kg IV daily for 2 days
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers
Baseline characteristics by cohort
| Measure |
BMT Allogenic Transplantation
n=15 Participants
Fludarabine, Busulfan, Cyclophosphamide, Tacrolimus,: Fludarabine 30 mg/m2 IV once a day for 4 days Busulfan 0.8 mg/kg IV every 12 hours for 4 days Cyclophosphamide 50 mg/kg IV daily for 2 days
|
|---|---|
|
Age, Continuous
|
49 years
n=99 Participants
|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Female
|
6 participants
n=99 Participants
|
|
Sex/Gender, Customized
Male
|
9 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 60Population: The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Percentage of participants achieving full-donor chimerism in unsorted peripheral blood.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 60Population: The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Percentage of participants achieving full-donor chimerism in CD3+ sorted peripheral blood
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Percentage of participants alive
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Percentage of participants alive without disease relapse or progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Percentage of participants experiencing disease relapse or progression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Percentage of participants who died due to BMT-related reasons
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: The trial has been terminated early since stopping rule criteria were met (high graft failure rate). Data were not analyzed.
Percentage of participants experiencing acute and chronic GVHD. Acute GVHD is graded by Przepiorka criteria. Chronic GVHD is graded by NIH consensus criteria and Seattle criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 60Percentage of participants who failed to engraft.
Outcome measures
| Measure |
BMT Allogenic Transplantation
n=15 Participants
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
|
|---|---|
|
Graft Failure
|
8 Participants
|
Adverse Events
Transplant
Serious adverse events
| Measure |
Transplant
n=15 participants at risk
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
|
|---|---|
|
Infections and infestations
Infection
|
46.7%
7/15 • Number of events 7 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
General disorders
Fever
|
13.3%
2/15 • Number of events 2 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Infections and infestations
Sepsis
|
13.3%
2/15 • Number of events 2 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
Other adverse events
| Measure |
Transplant
n=15 participants at risk
Reduced-intensity transplant with a fludarabine- and busulfan-based preparative regimen. GVHD prophylaxis with cyclophosphamide, tacrolimus, and mycophenolate mofetil.
|
|---|---|
|
Gastrointestinal disorders
nausea
|
6.7%
1/15 • Number of events 2 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
General disorders
fever
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Nervous system disorders
tremor
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Psychiatric disorders
hallucinations
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Investigations
Elevated liver enzymes
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Investigations
Elevated total bilirubin
|
6.7%
1/15 • Number of events 1 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
2/15 • Number of events 2 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Infections and infestations
Infection
|
26.7%
4/15 • Number of events 4 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
|
Infections and infestations
Febrile neutropenia
|
26.7%
4/15 • Number of events 4 • 1 year
Data was collected systematically through at least Day 60 by investigator assessment at protocol-specified visits.
|
Additional Information
Yvette Kasamon
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place