Clofarabine and Non-Myeloablative Allogeneic Hematopoietic Transplantation

Phase 1/2 Terminated 8 enrolled Milton S. Hershey Medical Center

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Allogeneic hematopoietic transplant is curative for many patients with hematological neoplasms but conditions to provide optimal engraftment and anti-tumor efficacy with minimal toxicity are still under way. Clofarabine is a newly licensed agent with dramatic anti-leukemic activity. Its incorporation into a regimen for pre-transplant conditioning of acute leukemia and lymphoma patients is logical, exploiting both the anti-tumor activities it is recognized to have and the immunosuppressive activity seen with drugs in its class.

Timeline

Start: 2007-05
Primary completion: 2010-01
Completion: 2010-01

Publications

Results Karch J, Zhu J, Ehmann WC, Claxton D. Clofarabine and CY do not yield reliable engraftment of hematopoietic stem cells. Bone Marrow Transplant. 2012 Aug;47(8):1134-5. doi: 10.1038/bmt.2011.224. Epub 2011 Nov 14. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clofarabine	Other / unclassified	30 mg/m2	—
Subject	Cyclophosphamide	Other / unclassified	500 mg/m2	—
Subject	Cyclophosphamide	Other / unclassified	1000 mg/m2	—
Background	Alemtuzumab	Monoclonal antibody	20 mg	—

Clofarabine and Non-Myeloablative Allogeneic Hematopoietic Transplantation

Summary

Timeline

Publications

Drugs

Indications