Status:
COMPLETED
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Hematologic Diseases
Leukemia
Eligibility:
All Genders
6-75 years
Phase:
PHASE2
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 ti...
Detailed Description
The Study Drugs: Busulfan is designed to bind to DNA (the genetic material of cells), which may cause cancer cells to die. Fludarabine is designed to make cancer cells less able to repair damaged DN...
Eligibility Criteria
Inclusion
- 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%.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00800839
Start Date
September 1 2008
Last Update
September 19 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030