NCT01457885

Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloblastic Leukemia

Interventions

Type	Name	Description
DRUG	Clofarabine/Busulfan x 4	* Clofarabine IV dose level: 40 mg/m2/day x 5 days * Busulfan IV dose level: 3.2 mg/kg daily x 4 days
PROCEDURE	Peripheral blood stem cell transplant	Peripheral blood stem cell transplant, after pre-conditioning drug treatment

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-11-01
• Completion: 2016-06-14
• First posted: 2011-10-24
• Last updated: 2017-06-02
• Results posted: 2016-07-25

Locations

12 sites across 2 countries: United States, Canada