Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)
Recruiting in Palo Alto (17 mi)
+25 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Medical College of Wisconsin
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
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
Treatment Details
Interventions
- Methotrexate (Antimetabolite)
- Sirolimus (mTOR inhibitor)
- Tacrolimus (Calcineurin inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Tacrolimus/SirolimusExperimental Treatment2 Interventions
Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
Group II: Tacrolimus/MethotrexateActive Control2 Interventions
Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
Methotrexate is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Trexall for:
- Acute lymphoblastic leukemia
- Non-Hodgkin's lymphoma
- Osteosarcoma
- Breast cancer
- Lung cancer
- Head and neck cancer
- Psoriasis
- Rheumatoid arthritis
🇨🇦 Approved in Canada as Mexate for:
- Acute lymphoblastic leukemia
- Non-Hodgkin's lymphoma
- Osteosarcoma
- Breast cancer
- Lung cancer
- Head and neck cancer
- Psoriasis
- Rheumatoid arthritis
🇪🇺 Approved in European Union as Methotrexate for:
- Acute lymphoblastic leukemia
- Non-Hodgkin's lymphoma
- Osteosarcoma
- Breast cancer
- Lung cancer
- Head and neck cancer
- Psoriasis
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Oklahoma Medical CenterOklahoma City, OK
University of Pennsylvania Cancer CenterPhiladelphia, PA
University of Wisconsin Hospital & ClinicsMadison, WI
Virginia Commonwealth University/MCV HospitalRichmond, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
Blood and Marrow Transplant Clinical Trials NetworkCollaborator
National Cancer Institute (NCI)Collaborator