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

Completed · Phase 3

Conditions studied: Leukemia, Myelocytic, Acute, Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Chronic, Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID

NCT00406393

Run by

Medical College of Wisconsin

People needed

304

Starts

2006-11-01

Expected to finish

2015-10-01

Last updated by the study team

2023-01-04

Who can join

Age: 2 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• UCSD Medical Center — La Jolla, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• University of Florida College of Medicine (Shands) — Gainesville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• DFCI/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
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals of Cleveland/Case Western — Cleveland, Ohio, United States
• Ohio State, Arthur G. James Cancer Hospital — Columbus, Ohio, United States
• University of Oklahoma Medical Center — Oklahoma City, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pennsylvania Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
• Texas Transplant Institute — San Antonio, Texas, United States
• Virginia Commonwealth University/MCV Hospital — Richmond, Virginia, United States
• University of Wisconsin Hospital & Clinics — Madison, Wisconsin, United States
• Hopital Saint-Louis — Paris, France

Full record on ClinicalTrials.gov

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