CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
pentostatindrug
Likely dose
4 mg/m² IV infusion over 20-30 minutes every 2 weeksAI-extracted
Key inclusion· 6
  • ✓Histologic documentation of chronic GvHD following allogeneic HCT or donor lymphocyte infusion
  • ✓Extensive stage chronic GvHD (generalized skin involvement OR limited skin involvement/hepatic involvement with liver histology, eye involvement, salivary/oral involvement, or other organ involvement)
  • ✓Failed corticosteroid therapy: progressive disease or <minor response after 2 weeks at ≥1 mg/kg methylprednisolone equivalent; OR failure to achieve minor response after ≥4 weeks at ≥0.5 mg/kg; OR <partial response at 8 weeks at ≥0.5 mg/kg; OR requirement of ≥0.5 mg/kg to maintain partial response at 12 weeks; OR >10 mg/kg to maintain partial response at 18 weeks
  • ✓Progressive extensive stage GvHD after ≥18 weeks of prior corticosteroid therapy, now requiring reinduction of corticosteroids (>10 mg/day methylprednisolone equivalent) or additional agent
Key exclusion· 4
  • ✕Limited stage chronic GvHD
  • ✕On mechanical ventilation
  • ✕Active infection requiring antibiotic therapy
  • ✕HIV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00074035
NCT00074035Phase 2Completed
CompareCT.gov

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

Alliance for Clinical Trials in Oncology·interventional·Posted Dec 11, 2003·Updated Nov 3, 2021

In Brief

A Phase 2 clinical trial evaluating pentostatin for Graft Versus Host Disease. Completed, enrolled 39 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft Versus Host Disease
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 11, 2003
Enrollment StartDec 1, 2003
Primary CompletionAug 1, 2008
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 22.6 years ago

Interventions

pentostatindrug

4 mg/sq m IV infusion over 20-30 min q 2 weeks