Acute Myeloblastic Leukemia Clinical Trial
Official title:
Multi-center Single Arm Phase II Study of Myeloablative Allogeneic Stem Cell Transplantation for Non-remission Acute Myeloblastic Leukemia (AML) Using Clofarabine and Busulfan x 4 (CloBu4) Regimen
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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