Trial Outcomes & Findings for Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY (NCT NCT00809276)
NCT ID: NCT00809276
Last Updated: 2015-02-16
Results Overview
Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
92 participants
Primary outcome timeframe
1 year
Results posted on
2015-02-16
Participant Flow
Participant milestones
| Measure |
BuFlu Transplant
Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
|
|---|---|
|
Overall Study
STARTED
|
92
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY
Baseline characteristics by cohort
| Measure |
BuFlu Transplant
n=92 Participants
Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
|
|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPercentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.
Outcome measures
| Measure |
BuFlu Transplant
n=92 Participants
Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
|
|---|---|
|
To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD
|
15 percentage of participants
Interval 8.0 to 23.0
|
Adverse Events
BuFlu Transplant
Serious events: 40 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BuFlu Transplant
n=92 participants at risk
Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
|
|---|---|
|
Blood and lymphatic system disorders
Primary graft failure
|
5.4%
5/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Investigations
Death
|
8.7%
8/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Investigations
ALT elevation grade 3-4
|
8.7%
8/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Investigations
AST elevation grade 3-4
|
6.5%
6/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Investigations
Hyperbilirubinemia grade 3-4
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Gastrointestinal disorders
Bowel obstruction
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Investigations
Alkaline phosphatase elevated grade 3-4
|
3.3%
3/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Gastrointestinal disorders
Gastritis and ileitis
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
2.2%
2/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Investigations
Hyperuricemia
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Investigations
Hypokalemia
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Cardiac disorders
Hypotension
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Infections and infestations
Infection
|
13.0%
12/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Gastrointestinal disorders
Mucositis
|
20.7%
19/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Infections and infestations
Neutropenic fever
|
12.0%
11/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Renal and urinary disorders
Renal toxicity
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Blood and lymphatic system disorders
Subdural hematoma
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Blood and lymphatic system disorders
Secondary graft failure
|
2.2%
2/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Blood and lymphatic system disorders
Diffuse alveolar hemorrhage
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary syndrome
|
1.1%
1/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
Other adverse events
| Measure |
BuFlu Transplant
n=92 participants at risk
Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
|
|---|---|
|
Investigations
AST elevation grade 3-4
|
12.0%
11/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Investigations
ALT elevation grade 3-4
|
21.7%
20/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Gastrointestinal disorders
Mucositis
|
6.5%
6/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Investigations
Engraftment > Day 28
|
12.0%
11/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
|
Investigations
Hyperbilirubinemia grade 3-4
|
7.6%
7/92 • Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place