drugset / Trial / NCT01001780

Pentostatin, Cyclophosphamide Plus Rituximab (PCR) for the Therapy of Poor-Prognosis Chronic Graft-Versus-Host Disease

NCT01001780

Phase 2 Withdrawn University of Rochester
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Chronic graft-versus-host disease (GvHD) is a severe, life threatening complication from getting a bone marrow or stem cell transplant. It is caused by certain cells from the donor that attack your cells. The usual treatments, prednisone and cyclosporine, don't work very well in chronic GVHD. This research is being done to determine if the combination of the chemotherapeutic and immunosuppressive, drugs pentostatin, cyclophosphamide and the monoclonal antibody rituximab, used as in the "PCR" combination will prove useful in the treatment of certain patients with chronic GvHD (namely those who are unlikely to respond to standard therapy).

Timeline

Start
2009-08
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Pentostatin Small molecule 2 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous