drugset / Trial / NCT01002742
Acute Graft-versus-Host Disease Treatment (BMT CTN 0802)
Phase 3
Completed
236 enrolled
Medical College of Wisconsin
National Cancer Institute (NCI) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2010-01
- Primary completion
- 2012-01
- Completion
- 2013-06
Publications
- Results Bolanos-Meade J, Logan BR, Alousi AM, Antin JH, Barowski K, Carter SL, Goldstein SC, Hexner EO, Horowitz MM, Lee SJ, Levine JE, MacMillan ML, Martin PJ, Mendizabal AM, Nakamura R, Pasquini MC, Weisdorf DJ, Westervelt P, Ho VT. Phase 3 clinical trial of steroids/mycophenolate mofetil vs steroids/placebo as therapy for acute GVHD: BMT CTN 0802. Blood. 2014 Nov 20;124(22):3221-7; quiz 3335. doi: 10.1182/blood-2014-06-577023. Epub 2014 Aug 28.
- Shah O, Tamaresis JS, Kenyon LJ, Xu L, Zheng P, Gupta P, Rangarajan K, Lee S, Spellman S, Nikiforow S, Zehnder J, Meyer EH. Analysis of the Whole CDR3 T Cell Receptor Repertoire after Hematopoietic Stem Cell Transplantation in 2 Clinical Cohorts. Biol Blood Marrow Transplant. 2020 Jun;26(6):1050-1070. doi: 10.1016/j.bbmt.2020.01.020. Epub 2020 Feb 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 20 mg/kg | Oral |
| Subject | Mycophenolate Mofetil | Small molecule | 750 mg | Oral |
| Subject | Mycophenolate Mofetil | Small molecule | 1000 mg | Oral |