Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide
Busulfan (IV) and Fludarabine Followed by Post-allogeneic Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies.
2 other identifiers
interventional
56
1 country
1
Brief Summary
The goal of this clinical research study is to learn if cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. The safety of this drug combination will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedResults Posted
Study results publicly available
September 19, 2016
CompletedSeptember 19, 2016
July 1, 2016
6.8 years
December 1, 2008
July 28, 2016
July 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cumulative Incidence of Grade II to IV Acute GVHD
Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
100 days post transplant
Cumulative Incidence of Grade III to IV Acute GVHD
Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
100 days post transplant
Day-100 Treatment-Related Mortality
Treatment-Related Mortality (TRM) was estimated from the date of transplant using the cumulative incidence method to account for competing risks. Disease progression or relapse death were considered competing risk for TRM.
100 days post transplant
Secondary Outcomes (3)
Rate of Engraftment
From engraftment to 60 days post transplant
2-year Progression-Free Survival
First 25-35 days post transplant and then every 3 months for a maximum of 2 years
2-year Overall Survival
First 25-35 days post transplant and then every 3 months for a maximum of 2 years
Study Arms (1)
Busulfan + Fludarabine + Cyclophosphamide
EXPERIMENTALBusulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
Interventions
Starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3.
Dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan.
Dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
Eligibility Criteria
You may qualify if:
- Patients with high risk hematological malignancies, including those with induction failure and after treated or untreated relapse.
- HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority.
- Age 6 months to 75 years.
- Bilirubin \</= 1.5 mg/dl, serum glutamate pyruvate transaminase (SGPT) \</= 200 IU/ml (unless Gilbert's syndrome).
- Calculated creatinine clearance of \>50mL/min using the Cockcroft-Gault equation for adult patients 18 to 70 years old, and the Schwartz equation for pediatric patients 6 months to 17 years old.
- Diffusing capacity for carbon monoxide (DLCO) \>45% predicted corrected for hemoglobin (as reported by the Pulmonary Function Laboratory at MDACC). For most children \</= 6 years of age who are unable to perform pulmonary function test (PFT), pulse oximetry \>/= 92% on room air.
- left ventricular ejection fraction (LVEF) \>/= 35%.
You may not qualify if:
- HIV seropositivity
- Uncontrolled infections.
- Positive Beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
- Inability to sign consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amin M. Alousi, MD/Stem Cell Transplantation
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Amin Alousi, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2008
First Posted
December 2, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2015
Last Updated
September 19, 2016
Results First Posted
September 19, 2016
Record last verified: 2016-07