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

• Status: Terminated
• Trial end date: 2005-11-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astex Pharmaceuticals; Astex Pharmaceuticals, Inc.
• Treatments: Pentostatin

Criteria

Inclusion:

• Patients 6 months of age with grade 2 GVHD that is steroid-refractory

• Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets and PRBC

• Time post stem cell infusion < 100 days

• Written informed consent

• Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2)

Exclusion:

• Post-transplant lymphoproliferative disease

• Uncontrolled infection

• Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study

• ATG within the previous 14 days

• Other immunosuppressive agents (including monoclonal antibodies) when initiated within the previous 7 days