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

August 1, 2024 updated by: Astex Pharmaceuticals, Inc.

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)

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astex Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2002

Primary Completion (Actual)

November 3, 2005

Study Completion (Actual)

November 3, 2005

Study Registration Dates

First Submitted

April 2, 2002

First Submitted That Met QC Criteria

April 3, 2002

First Posted (Estimated)

April 4, 2002

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGI-NIP-010
  • NIP-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Graft Versus Host Disease

Clinical Trials on pentostatin for injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe