Bone Marrow Transplant Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer
Condition: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer
      cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may
      allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an
      unrelated donor together with cyclophosphamide and total-body irradiation works in treating
      patients with hematologic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Study the curative potential of high-dose cyclophosphamide and total-body irradiation
           followed by rescue with bone marrow from volunteer HLA-matched donors in patients with a
           variety of hematologic malignancies and bone marrow failure states.

        -  Study the toxic effects associated with matched unrelated bone marrow transplantation in
           this patient population.

        -  Participate in collaborative research studies with the National Marrow Donor Program.

      OUTLINE: All patients receive myeloablative therapy with high-dose cyclophosphamide and total
      body irradiation over 4 days; patients with severe aplastic anemia also receive antithymocyte
      globulin. Patients then undergo allogeneic bone marrow transplantation. Filgrastim (G-CSF) is
      given after transplant to accelerate engraftment. Sargramostim (GM-CSF) may be given in case
      of graft failure.

      All patients receive graft-versus-host-disease (GVHD) prophylaxis with tacrolimus,
      methotrexate, and gamma globulin. Established GVHD is treated with corticosteroids and, as
      necessary, antithymocyte globulin.

      Patients are followed at 100 days, 6 months, and 1 year after transplant, then annually
      thereafter.

      PROJECTED ACCRUAL: A total of 10 patients per year will be accrued for this study over 5
      years.
    

Intervention name(s): anti-thymocyte globulin; filgrastim; sargramostim; therapeutic immune globulin; cyclophosphamide; methotrexate; tacrolimus; allogeneic bone marrow transplantation; radiation therapy
Intervention type(s): Biological; Biological; Biological; Biological; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Methotrexate; Tacrolimus; Antilymphocyte Serum; Sargramostim; Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; refractory chronic lymphocytic leukemia; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission; refractory anemia; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; secondary acute myeloid leukemia; previously treated myelodysplastic syndromes; atypical chronic myeloid leukemia; myelodysplastic/myeloproliferative disease, unclassifiable; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12)