drugset / Trial / NCT01252667

Clofarabine and Low-Dose Total-Body Irradiation in Treating Patients With Acute Myeloid Leukemia Undergoing Donor Peripheral Blood Stem Cell Transplant

NCT01252667

Non-randomizedSequentialOpen-labelTreatment

Summary

This phase II trial studies the side effects and how well clofarabine works when given together with low-dose total-body irradiation (TBI) in treating patients with acute myeloid leukemia (AML) undergoing donor peripheral blood stem cell transplant (PBSCT). Giving chemotherapy and TBI before a donor PBSCT helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Timeline

Start
2011-01-25
Primary completion
2019-01-25
Completion
2019-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 30 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 40 mg/m2 Intravenous
Subject Clofarabine Other / unclassified 50 mg/m2 Intravenous
Background Cyclosporine Peptide Oral
Background Mycophenolate Mofetil Small molecule Oral