Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant

Phase 1 Completed 46 enrolled Massachusetts General Hospital

Non-randomizedParallel-groupOpen-labelSupportive care

Summary

RATIONALE: Rasburicase may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying how well rasburicase works in preventing graft-versus-host disease in patients with hematologic cancer or other disease undergoing donor stem cell transplant.

Timeline

Start: 2008-01
Primary completion: 2013-02-12
Completion: 2013-02-12

Publications

Results Yeh AC, Brunner AM, Spitzer TR, Chen YB, Coughlin E, McAfee S, Ballen K, Attar E, Caron M, Preffer FI, Yeap BY, Dey BR. Phase I study of urate oxidase in the reduction of acute graft-versus-host disease after myeloablative allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2014 May;20(5):730-4. doi: 10.1016/j.bbmt.2014.02.003. Epub 2014 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rasburicase	Protein / enzyme biologic	0.2 mg/kg	Intravenous
Background	Allopurinol	Small molecule	—	—
Background	Busulfan	Small molecule	3.2 mg/kg	—
Background	Cyclophosphamide	Other / unclassified	—	—
Background	Cyclosporine	Peptide	—	—
Background	Etoposide	Small molecule	—	—
Background	Fludarabine	Small molecule	40 mg/m2	—
Background	Methotrexate	Small molecule	1.5 mg/kg	—
Background	Sirolimus	Small molecule	—	—
Background	Tacrolimus	Small molecule	—	—

Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant

Summary

Timeline

Publications

Drugs

Indications