Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen
Status:
Completed
Trial end date:
2016-06-14
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center
Collaborators:
Genzyme, a Sanofi Company Otsuka Pharmaceutical Development & Commercialization, Inc.