NCT00074035

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	pentostatin	4 mg/sq m IV infusion over 20-30 min q 2 weeks

Timeline

• Start date: 2003-12-01
• Primary completion: 2008-08-01
• Completion: 2014-11-01
• First posted: 2003-12-11
• Last updated: 2021-11-03
• Results posted: 2017-03-15

Locations

16 sites across 1 country: United States