Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder
Condition: Chronic Myeloproliferative Disorders; Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Giving chemotherapy drugs before a donor peripheral blood stem cell transplant
      helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system
      from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused
      into the patient they may help the patient's bone marrow make stem cells, red blood cells,
      white blood cells, and platelets. Giving colony-stimulating factors, such as G-CSF, to the
      donor helps the stem cells move from the bone marrow to the blood so they can be collected
      and stored.

      PURPOSE: This phase I/II trial is studying how well donor peripheral stem cell transplant
      works in treating patients with myelodysplastic syndrome, acute myeloid leukemia, or
      myeloproliferative disorder.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the incidence of grades II, III, and IV graft-vs-host disease (GVHD) in
           patients with myelodysplastic syndromes (MDS), acute myeloid leukemia transformed from
           MDS, or myeloproliferative disorders treated with immunologically engineered, filgrastim
           (G-CSF)-mobilized, allogeneic peripheral blood stem cell transplantation.

        -  Determine the incidence of graft failure, relapse, and transplant-related mortality by
           day 100 in patients treated with this regimen.

        -  Determine the incidence of chronic GVHD, in terms of number and duration of
           immunosuppressant therapies, in patients treated with this regimen.

        -  Determine the feasibility of partial T-cell depletion in G-CSF-mobilized peripheral
           blood stem cells.

      OUTLINE: Patients receive conditioning with oral busulfan every 6 hours on days -7 to -4 and
      cyclophosphamide IV on days -3 and -2. Immunologically engineered, filgrastim
      (G-CSF)-mobilized, allogeneic peripheral blood stem cells are infused on day 0.

      Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1, 3,
      6, and 11 and cyclosporine IV over 1-4 hours (orally twice daily when tolerated) on days -1
      to 80 and then gradually tapered over 5 months beginning on day 81.

      Patients are followed regularly through day 100 and then at 1 year.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
    

Intervention name(s): busulfan; cyclophosphamide; cyclosporine; methotrexate; in vitro-treated peripheral blood stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cyclosporine; Cyclophosphamide; Busulfan; Methotrexate; Cyclosporins
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; essential thrombocythemia; polycythemia vera; previously treated myelodysplastic syndromes; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; secondary acute myeloid leukemia; secondary myelodysplastic syndromes; chronic eosinophilic leukemia; chronic neutrophilic leukemia; atypical chronic myeloid leukemia; myelodysplastic/myeloproliferative disease, unclassifiable