Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide

Completed · Phase 2

Conditions studied: Hematologic Diseases, Leukemia, Lymphoma, Myeloma

In brief

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.

Key facts

Study ID

NCT00800839

Run by

M.D. Anderson Cancer Center

People needed

56

Starts

2008-09-01

Last updated by the study team

2016-09-19

Who can join

Age: 1 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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