S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: therapeutic allogeneic lymphocytes; cyclosporine; fludarabine; mycophenolate mofetil; peripheral blood stem cell transplantation; radiation therapy
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Fludarabine; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 55 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: adult acute myeloid leukemia in remission; 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

Summary:

      RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were
      destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an
      immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may
      prevent this from happening.

      PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation
      followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate
      mofetil in treating older patients who have acute myeloid leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Morphologically confirmed acute myeloid leukemia (AML) (within 180 days of diagnosis)
             OR

          -  Secondary AML (secondary to myelodysplastic syndromes (MDS) or to prior leukemogenic
             therapy)

          -  Must have A1 marrow, B1 blood, and C1 extramedullary disease status

          -  Must have received prior remission induction chemotherapy

          -  Must have a genotypically HLA-identical sibling donor available that is not a
             monozygotic identical twin

          -  No M3 AML or blastic transformation of chronic myelogenous leukemia

          -  If history of CNS leukemia, no leukemia cells in CNS by lumbar puncture within past 7
             days

          -  Must be concurrently enrolled on protocols SWOG-9007 and SWOG-S9910

        PATIENT CHARACTERISTICS:

        Age

          -  55 to 69

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  See Disease Characteristics

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No other malignancy within the past 2 years except for the following:

               -  Adequately treated basal cell or squamous cell skin cancer

               -  Carcinoma in situ of the cervix

               -  Adequately treated stage I or II cancer in complete remission

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior allogeneic hematopoietic stem cell transplantation

        Chemotherapy

          -  See Disease Characteristics

          -  Prior consolidation therapy allowed

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Prior organ transplantation allowed provided not concurrently receiving
             immunosuppressive therapy