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PURPOSE: Randomized phase II/III trial to determine the effectiveness of bone marrow transplantation in treating patients who have leukemia.
OBJECTIVES: I. Compare unrelated donor bone marrow transplantation using T-cell-depleted marrow versus unmodified marrow in adults and children with leukemia. II. Evaluate 2-year leukemia-free survival, primary and secondary graft failure, graft-versus-host disease, infection, and relapse in these patients. III. Assess the quality of life associated with T-cell-depleted versus unmodified, unrelated donor transplantation.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients receive myeloablative therapy according to diagnosis: those with acute lymphocytic leukemia and lymphoblastic lymphoma are treated with total body irradiation (TBI), with a testicular and chest wall boost as appropriate, followed by cyclophosphamide (CTX); patients with undifferentiated or biphenotypic leukemia or with acute or chronic myelocytic leukemia are treated with CTX followed by TBI. Patients are then randomly assigned to receive non-T-cell-depleted, unrelated marrow versus T-cell-depleted, unrelated marrow. The modified marrow is depleted of T-lymphocytes by counterflow elutriation and positively selected for CD34 cells. Graft-versus-host disease (GVHD) prophylaxis with cyclosporine and methotrexate is given to the unmodified marrow group. Patients who receive modified marrow are given antithymocyte globulin (or methylprednisolone) for graft rejection prophylaxis before transplantation and cyclosporine and methylprednisolone for GVHD prophylaxis after transplantation.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Graft Versus Host Disease
anti-thymocyte globulin, cyclophosphamide, cyclosporine, methotrexate, methylprednisolone, allogeneic bone marrow transplantation, in vitro-treated bone marrow transplantation, radiation therapy
University of Minnesota Cancer Center
Masonic Cancer Center, University of Minnesota
Published on BioPortfolio: 2014-07-24T14:35:16-0400
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Randomized comparison of cyclophosphamide versus reduced-dose cyclophosphamide plus fludarabine in addition to anti-thymocyte globulin for the conditioning therapy in allogeneic hematopoie...
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A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies.
A PREDNISOLONE derivative with similar anti-inflammatory action.
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
Immunizing agent containing IMMUNOGLOBULIN G anti-Rho(D) used for preventing Rh immunization in Rh-negative individuals exposed to Rh-positive red blood cells.
A glycoprotein migrating as alpha 1-globulin, molecular weight 70,000 to 120,000. The protein, which is present in increased amounts in the plasma during pregnancy, binds mainly progesterone, with other steroids including testosterone competing weakly.
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