Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Peripheral stem cell or bone marrow transplantation may be able
      to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.
      Sometimes the transplanted cells can make an immune response against the body's normal
      tissues. Stem cells that have been treated in the laboratory with filgrastim may prevent this
      from happening. Combining chemotherapy with bone marrow or peripheral stem cell
      transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more
      cancer cells. It is not yet known which treatment is more effective for chronic myeloid
      leukemia.

      PURPOSE: Randomized phase III trial to compare the effectiveness of donor peripheral stem
      cell transplantation with donor bone marrow transplantation in treating patients with chronic
      myeloid leukemia.
    

Detailed description: 
      OBJECTIVES: I. Compare the incidence of persistent cytogenetic or hematologic relapse in
      patients with chronic myeloid leukemia in chronic or accelerated phase treated with
      transplantation using filgrastim (G-CSF)-mobilized peripheral blood stem cells vs bone marrow
      from HLA-identical, related donors. II. Compare survival and nonrelapse mortality in patients
      treated with these regimens. III. Compare incidence and severity of acute and chronic graft
      versus host disease in patients treated with these regimens. IV. Compare hospitalization and
      treatment associated expenses for patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
      (15-39 vs 40-65), interval from diagnosis to transplantation (under 2 years vs 2 years or
      more, and permutations of patient and donor gender. Patients are randomized to one of two
      treatment arms. Arm I: Patients receive a preparative regimen comprising busulfan orally or
      IV 4 times daily on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Allogeneic
      filgrastim (G-CSF)-mobilized peripheral blood stem cells are infused on day 0. Arm II:
      Busulfan and cyclophosphamide are administered as in arm I. Allogeneic bone marrow is infused
      on day 0. Patients receive graft-versus-host disease prophylaxis comprising methotrexate IV
      on days 1, 3, 6, and 11 and cyclosporine IV over 1-4 hours or orally every 12 hours on days
      -1 to 80 and then tapered. Patients are followed every 6 months for 2 years and then annually
      thereafter.

      PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
    

Intervention name(s): busulfan; cyclophosphamide; cyclosporine; methotrexate; allogeneic bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Cyclosporine; Cyclophosphamide; Busulfan; Methotrexate; Cyclosporins
Allocation: Randomized
Primary purpose: Treatment
Keywords: chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; Philadelphia chromosome positive chronic myelogenous leukemia