Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)

Not Recruiting

Trial ID: NCT00406393

Purpose

The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.

Official Title

A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus With Tacrolimus/Methotrexate as Graft-versus-Host Disease (GVHD) Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (BMT CTN #0402)

Stanford Investigator(s)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


Inclusion Criteria:

   - 6/6 HLA-matched sibling, defined by Class I (HLA-A and B) serologic typing (or higher
   resolution) and Class II (HLA-DRBI) molecular typing, who is willing to donate
   peripheral blood stem cells, and meets institutional criteria for stem cell donation.
   The donor must be medically eligible to donate stem cells, according to individual
   transplant center criteria. Pediatric patients for whom a pediatric sibling donor is
   not anticipated to be a suitable leukapheresis candidate are not eligible.

   - Karnofsky performance status of at least 70% or Lansky performance status of at least
   70% for participants less than 16 years old

   - For participants less than 18 years old, willing and able to take oral medications,
   per the treating physician's recommendations

Exclusion Criteria:

   - Prior allogeneic or autologous transplant using any hematopoietic stem cell source

   - Seropositive for the human immunodeficiency virus (HIV)

   - Uncontrolled bacterial, viral, or fungal infection (currently taking medication and
   progression of clinical symptoms)

   - Pregnant (positive serum human chorionic gonadotropin [β-HCG] test) or breastfeeding
   within 4 weeks of study entry

   - Kidney function: serum creatinine outside the normal range for age, or measured
   creatinine clearance less than 50 mL/min/1.72m^2 within 4 weeks of study entry

   - Liver function: most recent direct bilirubin, alanine aminotransferase (ALT), or
   aspartate aminotransferase (AST) greater than two times the upper limit of normal
   within 4 weeks of study entry

   - Lung disease: in adults, forced vital capacity (FVC) or forced expiratory volume in
   one second (FEV1) less than 60% of predicted value (corrected for hemoglobin); in
   children, overt hypoxemia, as measured by an oxygen saturation of less than 92% within
   4 weeks of study entry

   - Cardiac ejection fraction of less than 45% in adults and children, or less than 26%
   shortening fraction in children within 4 weeks of study entry

   - Cholesterol level greater than 500 mg/dL or triglyceride level greater than 500 mg/dL
   while being treated, or not on appropriate lipid-lowering therapy within 4 weeks of
   study entry

   - Prior history of allergy to sirolimus

   - Requires voriconazole at time of study entry

   - Currently receiving another investigational drug unless cleared by the protocol
   officer or protocol chair

   - Participants with a history of cancer, other than resected basal cell carcinoma or
   treated carcinoma in-situ. Cancer treated with curative intent for more than 5 years
   previously will be allowed. Cancer treated with curative intent for less than 5 years
   previously will not be allowed unless approved by the protocol officer or protocol
   chair.

Intervention(s):

drug: Tacrolimus

drug: Methotrexate

drug: Sirolimus

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
650-723-0822

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