Sibling Donor Peripheral Stem Cell Transplant or Sibling Donor Bone Marrow Transplant in Treating Patients With Hematologic Cancers or Other Diseases
Condition: Chronic Myeloproliferative Disorders; Graft Versus Host Disease; Leukemia; Lymphoma; Myelodysplastic Syndromes; Secondary Myelofibrosis
MeSH terms: Lymphoma; Leukemia; Preleukemia; Neoplasm Metastasis; Myelodysplastic Syndromes; Primary Myelofibrosis; Myeloproliferative Disorders; Graft vs Host Disease; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Giving chemotherapy before a donor peripheral stem cell transplant or bone marrow
      transplant using stem cells from a brother or sister that closely match the patient's stem
      cells, helps stop the growth of cancer or abnormal cells. It also helps stop the patient's
      immune system from rejecting the donor's stem cells. The donated stem cells may replace the
      patient's immune cells and help destroy any remaining cancer or abnormal cells
      (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an
      immune response against the body's normal cells. 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. Giving methotrexate and cyclosporine before and after transplant may
      stop this from happening. It is not yet known whether a donor peripheral stem cell transplant
      is more effective than a donor bone marrow transplant in treating hematologic cancers or
      other diseases.

      PURPOSE: This randomized phase III trial is studying filgrastim-mobilized sibling donor
      peripheral stem cell transplant to see how well it works compared with sibling donor bone
      marrow transplant in treating patients with hematologic cancers or other diseases.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the time to treatment failure in patients with hematologic malignancies or other
           diseases treated with filgrastim (G-CSF)-mobilized matched-sibling donor peripheral
           blood stem cell transplantation vs G-CSF-stimulated matched-sibling donor bone marrow
           transplantation.

      Secondary

        -  Compare the hematological recovery and overall survival of patients treated with these
           regimens.

        -  Compare the quality of life, in terms of extensive graft-versus-host disease (GVHD), in
           patients treated with these regimens.

        -  Compare the economic impact associated with these treatment regimens.

      Tertiary

        -  Compare the incidence and severity of acute GVHD in patients treated with these
           regimens.

        -  Compare organ involvement, symptomatology, and functional impact of chronic GVHD in
           patients treated with these regimens.

        -  Compare disease-free survival of patients treated with these regimens.

        -  Compare donor quality of life.

        -  Compare cost analysis, from a societal perspective, of these treatment regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      treatment center, disease (chronic myelogenous leukemia vs acute myeloid leukemia vs
      myelodysplastic syndromes vs other hematologic malignancy), disease stage (early disease vs
      late disease), and conditioning regimen (busulfan and cyclophosphamide vs cyclophosphamide
      and total body irradiation vs other).

        -  Myeloablative conditioning regimen: Patients receive a myeloablative conditioning
           regimen that has been approved by the clinical chair.

        -  Stem cell transplantation (SCT): Patients are randomized to 1 of 2 SCT arms.

             -  Arm I: Patients undergo sibling donor filgrastim (G-CSF)-mobilized peripheral blood
                SCT on day 0.

             -  Arm II: Patients undergo sibling donor G-CSF- mobilized bone marrow transplantation
                on day 0.

        -  Graft-verus-host disease (GVHD) treatment: Patients receive methotrexate IV on days 1,
           3, 6, and 11 and cyclosporine IV (or orally) every 12 hours beginning on day -2 and
           continuing until day 100.

      Quality of life is assessed at baseline and at 1 and 3 years post-transplantation.

      After completion of study therapy, patients are followed periodically for at least 4 years.

      PROJECTED ACCRUAL: A total of 230 patients will be accrued for this study.
    

Intervention name(s): filgrastim; allogeneic bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Biological; Procedure; Procedure
Intervention description(s): Given on day 0.; Given on day 0; Given on day 0
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Primary purpose: Treatment
Keywords: graft versus host disease; adult acute myeloid leukemia in remission; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); accelerated phase chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; refractory anemia with excess blasts in transformation; refractory anemia with excess blasts; refractory anemia with ringed sideroblasts; refractory anemia; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; refractory chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; primary myelofibrosis; secondary myelofibrosis; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult Hodgkin lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent mycosis fungoides/Sezary syndrome; recurrent small lymphocytic lymphoma; splenic marginal zone lymphoma; stage III adult Burkitt lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult Hodgkin lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III mantle cell lymphoma; stage III marginal zone lymphoma; stage III small lymphocytic lymphoma; stage IV adult Burkitt lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult Hodgkin lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV mantle cell lymphoma; stage IV marginal zone lymphoma; stage IV small lymphocytic lymphoma; Waldenström macroglobulinemia; secondary acute myeloid leukemia; childhood myelodysplastic syndromes