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Acute Graft-versus-Host Disease Treatment (BMT CTN 0802)

NCT01002742 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2023-01-04

Study results available
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Summary

The study is a Phase III, randomized double blind, placebo controlled, and trial evaluating the addition of Mycophenolate mofetil (MMF) vs. placebo to systemic corticosteroids as initial therapy for acute Graft Vs Host Disease (GVHD). The primary endpoint will be GVHD free survival at Day 56 post randomization.

Conditions

  • Graft-versus-Host Disease
  • Immune System Disorders

Interventions

DRUG

Mycophenolate Mofetil

Oral dosing should be delivered in 250 mg units. For those \< 40 kg, IV dosing should be within ± 10% of the exact dose. Intravenous doses are infused over a two-hour period. * Patients who weight \> 60 kg should receive MMF 1 gm PO/IV every 8 hours. * Patients who weight between 40-60 kg should receive 750 mg PO/IV every 8 hours. * Patients who weight \<40 kg should receive 20 mg/kg IV or PO every 8 hours.

DRUG

Placebo

Oral dosing should be delivered in 250 mg units blinded placebo. For those \< 40 kg, IV dosing should be within ± 10% of the exact dose. Intravenous doses are infused over a two-hour period. * Patients who weight \> 60 kg should receive placebo 1 gm PO/IV every 8 hours. * Patients who weight between 40-60 kg should receive 750 mg PO/IV every 8 hours. * Patients who weight \<40 kg should receive 20 mg/kg IV or PO every 8 hours.

Sponsors & Collaborators

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

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-01-31
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01002742 on ClinicalTrials.gov