At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double Blind, Phase III Trial Evaluating Corticosteroids With Mycophenolate Mofetil vs. Corticosteroids With Placebo as Initial Systemic Treatment of Acute Graft-Vs-Host-Disease (BMT CTN #0802)
In Brief
A Phase 3 clinical trial evaluating Mycophenolate Mofetil and Placebo for Graft-versus-Host Disease and Immune System Disorders. Completed, enrolled 236 participants across 36 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.