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Protocol No. BMTCTN1301

Principal Investigator Hematti, Peiman

Phase III

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus-Host Disease

Objective The purpose of this study is to compare three different combinations of treatment plans to see whether one or more of them are better than a standard transplant procedure for a common problem that may occur after hematopoietic stem cell transplant (HSCT). It is a condition known as Graft-Versus-Host Disease (GVHD). The word "host" refers to the person (in this case, you) receiving the cells. The word "graft" refers to the donor blood cells that you will receive during your transplant. GVHD is a complication where the donor graft attacks and damages some of your (the transplant recipient's) tissues.The procedures being studied have the objective to reduce the occurrence of chronic GVHD.

Treatment The procedures included in this clinical trial are: Treatment Group A: CD34 Selected Peripheral Blood Stem Cell Transplan, Treatment Group B: Bone Marrow Transplant followed by Post-Transplant Cyclophosphamide, Treatment Group C: Bone Marrow Transplant with Tacrolimus and Methotrexate as GVHD Prevention. Treatment group A uses an investigational device - the CliniMACS® CD 34 Reagent System - to process hematopoietic stem cells collected by Apheresis. Although approved by the FDA for other uses, this clinical trial will further assess the safety and efficiency of the CliniMACS® CD34 selection in patients with your disease. Treatment groups B and C use chemotherapy agents after the transplant.

Description We will use a computer to randomly assign you to 1 of 3 treatment groups. You will have an equal chance of being placed in 1 of the 3 groups. Treatment Group A : CD34 Peripheral Blood Stem Cell Graft involves the donor graft processed through a device that removes cells that are associated with the development of GVHD. This device is the Miltenyi ClinicMACS® CD34 Reagent System and its use in this clinical trial is investigational. Patients in treatment Group B: Post-Transplant Cyclophosphamide will receive cyclophosphamide intravenous infusion (through your vein), over 1-2 hours, on Day 3 and Day 4 after your transplant. Patients in Treatment Group C: Tacrolimus and Methotrexate will receive Tacrolimus as a pill by mouth or intravenous infusion twice a day, beginning three (3) days before your transplant. After your transplant Methotrexate will be given by intravenous infusion (through your vein)on four (4) different days (1, 3, 6 and 11)

Key Eligibility
  • Males and females aged ≥ 1.0 year and < 66.0 years
  • Patients with acute leukemia in morphologic complete remission or with myelodysplasia (MDS) with no circulating blasts and with less than 5% blasts in the bone marrow.
  • Patients with CMML must have a WBC count ≤10,000 cells/μL and <5% blasts in the marrow
  • Patients must have a related or unrelated donor. Related donor must be an 8/8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing. Unrelated donor must be an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing
  • Patients who have had prior autologous or allogeneic hematopoietic stem cell transplant are excluded
  • Patients who are positive for HIV-2 or -2 or HTLV-I or -II are excluded
  • Patients with a history of uncontrolled autoimmune disease or on active treatment are excluded

Applicable Disease Sites Bone Marrow Transplant; Leukemia

Therapies Involved Bone Marrow Transplant; Cytotoxic Chemotherapy; Other

Drugs Involved Prograf (tacrolimus); alkeran (melphalan); bsf (busulfan); busulfan; cpm (cyclophosphamide); ctx (cyclophosphamide); cyclophosphamide; cytoxan (cyclophosphamide); f-ara-amp (fludarabine); flamp (fludarabine); fludara (fludarabine); fludarabine; hdmtx (methotrexate); it-mtx (methotrexate); lpam (melphalan); melphalan; methotrexate; mtx (methotrexate); neosar (cyclophosphamide); rabbit antithymocyte globulin; tacrolimus; thymoglobulin (rabbit antithymocyte globulin)

Status Open

Participating Institutions UW Hospital and Clinics