drugset / Trial / NCT00623935

Blood Stem Cell Transplantation for the Treatment of Older Patients With Acute Myelogenous Leukemia

NCT00623935 ↗

Phase 2 Completed 56 enrolled University of Michigan Rogel Cancer Center
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The prognosis for older individuals with acute myelogenous leukemia (AML) has been historically poor, with 2 year disease-free survival rates \< 20% reported. Younger patients with AML in first complete remission are routinely treated using a full intensity (myelo-ablative) chemotherapy followed by a blood stem cell transplant. For the older patient with AML, full intensity therapy transplants have been greatly limited by increased rates of toxic effects related to this type of conditioning regimen. Reduced intensity (non-myeloablative) conditioning regimens have been used in a number of clinical settings, including AML therapy, to lessen the regimen related toxicity in the older patient. Recent data from the University of Michigan Blood and Marrow Transplant Program suggests improved survival for individuals \> 55 years in age undergoing reduced intensity, transplants from unrelated donors. This study will investigate the safety and efficacy of this treatment option for older patients with AML, with the primary goal being to improve the survival and lifespan for older patients with AML.

Timeline

Start
2007-03
Primary completion
2013-06
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 3.2 mg/m2 —
Subject Fludarabine Small molecule 40 mg/m2 —