Conditions: Acute Myeloblastic Leukemia
Keywords: AML
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 75
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant

Interventions: intervention 1: Clofarabine/Busulfan x 4 intervention 2: Peripheral blood stem cell transplant
Intervention descriptions: intervention 1: * Clofarabine IV dose level: 40 mg/m2/day x 5 days
* Busulfan IV dose level: 3.2 mg/kg daily x 4 days intervention 2: Peripheral blood stem cell transplant, after pre-conditioning drug treatment

Protocol document: