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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-30

Study Completion Date

2005-11-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Graft Versus Host Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pentostatin for injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No