Overview

Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Busulfan
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Vidarabine
Criteria
Inclusion Criteria:

1. Patients with high risk hematological malignancies, including those with induction
failure and after treated or untreated relapse.

2. HLA-identical sibling or matched unrelated donor transplants not eligible for
protocols of higher priority.

3. Age 6 months to 75 years.

4. Bilirubin (unless Gilbert's syndrome).

5. 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.

6. Diffusing capacity for carbon monoxide (DLCO) >45% predicted corrected for hemoglobin
(as reported by the Pulmonary Function Laboratory at MDACC). For most children years of age who are unable to perform pulmonary function test (PFT), pulse oximetry
>/= 92% on room air.

7. left ventricular ejection fraction (LVEF) >/= 35%.

Exclusion Criteria:

1. HIV seropositivity

2. Uncontrolled infections.

3. 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

4. Inability to sign consent