NCT00623935

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine (40 mg/m2/day x 4 days)
DRUG	Busulfan	Busulfan (3.2 mg/m2/day x 2 days or x 4 days).
RADIATION	Total Body Irradiation	Patients who receive Busulfan 3.2 mg/m2/day x 2 days and a mismatched allograft (7/8 HLA match) will also receive 200 cGy of total body irradiation (TBI) pre-transplant.
PROCEDURE	Stem Cell Transplant	Allogeneic stem cell transplant from related or unrelated donor

Timeline

• Start date: 2007-03-01
• Primary completion: 2013-06-01
• Completion: 2015-11-01
• First posted: 2008-02-26
• Last updated: 2016-04-08
• Results posted: 2014-07-17

Locations

1 site across 1 country: United States