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Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)

NCT00224874 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-11-01

Study results available
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Summary

The study is a randomized Phase II, four arm treatment trial. The primary purpose of the study is to define new agents with promising activity against acute graft-versus-host disease (GVHD) suitable for testing against corticosteroids alone in a subsequent Phase III trial.

Conditions

  • Graft vs Host Disease
  • Immune System Disorders

Interventions

DRUG

Etanercept

Etanercept \[25 mg subcutaneously twice weekly for up to 4 weeks; discontinue if in complete response by 4 weeks\].

DRUG

Mycophenolate Mofetil

Mycophenolate mofetil (MMF) \[20 mg/kg (maximum 1 gm) orally or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks\].

DRUG

Denileukin Diftitox

Denileukin Diftitox (ONTAK®) \[9 mcg/kg intravenously Days 1, 3, 5, 15, 17, 19\].

DRUG

Pentostatin

Pentostatin \[1.5 mg/m2 daily for 3 days; Days 1-3 and repeat Days 15-17

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Blood and Marrow Transplant Clinical Trials Network

    collaborator NETWORK

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Mary Horowitz, MD · Center for International Blood and Marrow Transplant Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-01-31
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00224874 on ClinicalTrials.gov