NCT00032773

Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD

A Sequentially Adaptive, Open Label, Dose-finding, Phase I/II Trial of Pentostatin in the Treatment of Steroid-refractory Acute Graft Versus Host Disease (aGvHD)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (planned)
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while producing treatment failure (defines as death, grade 3/4 toxicity, or progressive disease) in 40% or less of patients.

Conditions

• Acute Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	pentostatin for injection

Timeline

• Start date: 2002-01-30
• Primary completion: 2005-11-03
• Completion: 2005-11-03
• First posted: 2002-04-04
• Last updated: 2024-08-02

Locations

1 site across 1 country: United States