Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Medical College of Wisconsin

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Intervention(s):

  • Drug: Mycophenolate Mofetil
  • Drug: Placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - 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.

Exclusion Criteria:

   - 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.

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
650-723-0822
Not Recruiting