Conditions: Acute Myelogenous Leukemia
Keywords: AML
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 56
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Patients in CR will receive a reduced intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu2). arm 2: Patients in PR will receive a full intensity transplant regimen consisting of Fludarabine plus Busulfan (FluBu4).

Interventions: intervention 1: Fludarabine intervention 2: Busulfan intervention 3: Total Body Irradiation intervention 4: Stem Cell Transplant
Intervention descriptions: intervention 1: Fludarabine (40 mg/m2/day x 4 days) intervention 2: Busulfan (3.2 mg/m2/day x 2 days or x 4 days). intervention 3: 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. intervention 4: Allogeneic stem cell transplant from related or unrelated donor

Protocol document: