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

Phase 2TerminatedNCT00032773

Astex Pharmaceuticals, Inc.36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Graft Versus Host Disease

Interventions

pentostatin for injectionDRUG

Eligibility

Sex: ALLMin age: 6 Months

Medical Language ↔ Plain English

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

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Data from ClinicalTrials.gov

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