Although transplant results for AML in complete remission (CR) at the time of transplant have improved, transplant results for non-remission AML have been quite poor. Most multi-center studies have focused on standard risk AML patients and not many studies have been done in this population of patients with non-remission AML. There are a large number of older patients with non-remission AML because the complete remission rate with induction chemotherapy decreases with age. Such older patients do not tolerate conventional full intensity conditioning regimens. Thus, an effective and tolerable conditioning regimen for non-remission AML is a great unmet need for current transplant practice. From the investigators earlier study, it is suggested that replacing Fludarabine of standard FluBu4 regimen by Clofarabine (a related drug with much more potent anti-leukemia effect) in the transplant conditioning regimen may potentiate the anti-tumor activity of the conditioning regimen without adding significant toxicity, a goal of new conditioning regimen development. The investigators expect to enroll a total of 75 patients from about fifteen sites. The investigators main objective is to confirm both the safety and efficacy as measured by one-year overall survival, of the CloBu4 combination as full intensity conditioning for non-remission acute myelogenous leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
* Clofarabine IV dose level: 40 mg/m2/day x 5 days * Busulfan IV dose level: 3.2 mg/kg daily x 4 days
Peripheral blood stem cell transplant, after pre-conditioning drug treatment
University of Alabama, Birmingham
Birmingham, Alabama, United States
City of Hope National Medical Center
Duarte, California, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
Washington University at St Louis
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbuilt University
Nashville, Tennessee, United States
University of Washington
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
...and 2 more locations
Cumulative Incidence of Non Relapse Mortality (NRM)
Percentage of patients passed without relapse/recurrence at 1 year.
Time frame: 1 year
The Percentage of Patients Alive at 1 Year
Overall survival was calculated following transplant using a CloBu4 conditioning regimen for patients with non-remission AML
Time frame: 1 year
Incidence of Relapse
Time frame: 2 years
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