Study of Stem Cell Transplantation for Hematologic Malignancies Using Clofarabine and Busulfan Regimen

Phase 1/2 Completed 46 enrolled University of Michigan Rogel Cancer Center Genzyme, a Sanofi Company · collab

NaSingle-groupOpen-labelTreatment

Summary

The goals of the study are (Phase I) to determine the appropriate dose for Clofarabine with Busulfan as a full-intensity conditioning (Clo/BU4 regimen) prior to transplant and then (Phase II) to investigate the safety and effectiveness of this regimen as a conditioning for stem cell transplant in the treatment of aggressive hematologic malignancies in subjects where more conventional approaches are failing.

Timeline

Start: 2007-10
Primary completion: 2011-06
Completion: 2012-09

Publications

Magenau J, Tobai H, Pawarode A, Braun T, Peres E, Reddy P, Kitko C, Choi S, Yanik G, Frame D, Harris A, Erba H, Kujawski L, Elenitoba-Johnson K, Sanks J, Jones D, Paczesny S, Ferrara J, Levine J, Mineishi S. Clofarabine and busulfan conditioning facilitates engraftment and provides significant antitumor activity in nonremission hematologic malignancies. Blood. 2011 Oct 13;118(15):4258-64. doi: 10.1182/blood-2011-06-358010. Epub 2011 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clofarabine	Other / unclassified	20 mg/m2	Intravenous
Subject	Clofarabine	Other / unclassified	30 mg/m2	Intravenous
Subject	Clofarabine	Other / unclassified	40 mg/m2	Intravenous
Background	Busulfan	Small molecule	3.2 mg/kg	Intravenous

Study of Stem Cell Transplantation for Hematologic Malignancies Using Clofarabine and Busulfan Regimen

Summary

Timeline

Publications

Drugs

Indications