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

Sponsor

Astex Pharmaceuticals, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00032773

Collaborator

(none)

Enrollment

Location

45.1

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Graft Versus Host Disease	Drug: pentostatin for injection	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Jan 30, 2002

Actual Primary Completion Date :

Nov 3, 2005

Actual Study Completion Date :

Nov 3, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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