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Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease

Graft Versus Host Disease Clinical Trial

Official title:
A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease

Clinical Trial Summary

RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells. PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory (not responsive) to treatment with steroids.

Clinical Trial Description

OBJECTIVES: Primary - Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin. Secondary - Determine the time to next immunosuppressive agent (i.e., the time to progression from best response) in patients treated with this drug. - Determine the toxicity of this drug in these patients. - Determine the infection rate in patients treated with this drug. - Determine the pharmacokinetics of this drug in these patients. - Determine the changes in lymphocyte populations in patients treated with this drug. - Determine the survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive pentostatin IV over 20-30 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response after 6 courses receive 4 additional courses. Patients who achieve a partial response, minor response, or stable disease after 6 courses may receive up to 6 additional courses. Patients are followed every 4 weeks for 1 year, every 3 months for 2 years, and then annually for 5 years. PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00074035
Study type Interventional
Source Alliance for Clinical Trials in Oncology
Contact
Status Completed
Phase Phase 2
Start date December 2003
Completion date November 1, 2014
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