drugset / Trial / NCT00469014

Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia

NCT00469014

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the best dose of clofarabine and fludarabine that can be given with busulfan followed by an allogeneic blood stem cell transplant. Researchers will study whether this combination can help to control the disease, and look at the safety of this combination. Researchers also want to find out if combining busulfan with clofarabine alone or combining busulfan with both fludarabine and clofarabine will improve the treatment, compared with the previous standard method using busulfan and fludarabine alone.

Timeline

Start
2006-09
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 10 mg/m2 Intravenous
Subject Busulfan Small molecule 20 mg/m2 Intravenous
Subject Busulfan Small molecule 30 mg/m2 Intravenous
Subject Busulfan Small molecule 40 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 10 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 20 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 30 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 40 mg/m2 Intravenous
Subject Fludarabine Small molecule 10 mg/m2 Intravenous
Subject Fludarabine Small molecule 20 mg/m2 Intravenous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Background Thymoglobulin Protein / enzyme biologic 2 mg/kg Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous