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

Completed · Phase 3 · Has a placebo group

Conditions studied: Graft-versus-Host Disease, Immune System Disorders

In brief

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.

Key facts

Study ID

NCT01002742

Run by

Medical College of Wisconsin

People needed

236

Starts

2010-01-01

Expected to finish

2013-06-01

Last updated by the study team

2023-01-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute GVHD developing after allogeneic hematopoietic stem cell transplant using either bone marrow, peripheral blood stem cells or cord blood. Recipients of non-myeloablative and myeloablative transplants are eligible.
• Acute GVHD after planned donor lymphocyte infusion or planned T cell add back are eligible.
• De novo acute GVHD requiring systemic therapy. GVHD is defined as the presence of skin rash and/or persistent nausea, vomiting, and/or diarrhea and/or cholestasis presenting in a context in which acute GVHD is likely to occur and where other etiologies such as drug rash, enteric infection, or hepatotoxic syndromes are unlikely or have been ruled out. Note that patients with stage I and II skin only (overall grade I) or isolated upper gastrointestinal (GI) involvement are eligible if the treating physician deems that systemic high-dose corticosteroid treatment is indicated.
• The patient must have had no previous systemic immune suppressive therapy for treatment of acute GVHD except for a maximum 72 hours of prior corticosteroid therapy at >0.5mg/kg methylprednisolone or equivalent after the onset of acute GVHD.
• Clinical status at enrollment to allow tapering of steroids to not less than 0.25 mg/kg/day prednisone (0.2 mg/kg/day methylprednisolone) at Day 28 of therapy.
• Absolute neutrophil count (ANC) greater than 500/µL.
• Written informed consent and/or assent from patient, parent or guardian.
• Documentation that the assent document and education materials have been provided to, and reviewed with, patients between the ages of 7 and 17.
• Patients of all ages are eligible.
• Biopsy confirmation of GVHD is recommended, but not required. Enrollment should not be delayed for biopsy or pathology results unless these are to be used to decide about whether to treat for GVHD.

You may not qualify if…

• Patients receiving mycophenolate mofetil or mycophenolic acid (Myfortic) within seven days of screening for enrollment.
• Patients with uncontrolled infections will be excluded. If a bacterial or viral infection is present, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. If a fungal infection is present, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
• Relapsed/persistent malignancy requiring rapid immune suppression withdrawal.
• Patients with GVHD after an unplanned Donor Lymphocyte Infusion (DLI), i.e., DLI that was not part of their original transplant therapy plan, or DLI given for treatment of persistent or recurrent malignancy after transplantation.
• Patients unlikely to be available at the transplantation center on Day 28 and 56 of therapy.
• A clinical syndrome resembling de novo chronic GVHD developing at any time after allotransplantation.
• Patients receiving other drugs for the treatment of GVHD.
• Patients receiving methylprednisolone > 0.5 mg/kg/day (or 0.6 mg/kg/day prednisone) within 7 days before the onset of acute GVHD. If steroid therapy has been administered for treatment of a non-GVHD related condition and tapered to ≤ 0.5 mg/kg/day methylprednisolone (0.6 mg/kg/day prednisone) for seven or more days before the onset of acute GVHD, the patient is eligible.
• Patients who are pregnant, breast feeding, or, if sexually active, unwilling to use effective birth control for the duration of the study. Available evidence and/or expert consensus is inconclusive or is inadequate for determining infant risk when used during breastfeeding, therefore breast feeding patients are not eligible.
• Adults unable to provide informed consent.
• Patients on dialysis.
• Patients with severe hepatic Veno-Occlusive Disease (VOD) or sinusoidal obstruction syndrome who in the judgement of the treating physician are not expected to have normalized bilirubin by Day 56 after enrollment.
• Patients with a history of intolerance/allergy to MMF.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• University of California San Diego Medical Center — La Jolla, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• BMT Program at Northside Hospital — Atlanta, Georgia, United States
• Ann & Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana BMT at Beech Grove — Beech Grove, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Maryland Medical Systems — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• DFCI, Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute, Brigham & Women's Hospital — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University, Barnes Jewish Hospital — St Louis, Missouri, United States
• Hackensack Univ. Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College, NY Presbyterian Hospital — New York, New York, United States
• University of North Carolina Hospital at Chapel Hill — Chapel Hill, North Carolina, United States
• Levine Children's Hospital, Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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