Donor Bone Marrow Transplant in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
Condition: Chronic Myeloproliferative Disorders; Leukemia; Multiple Myeloma and Malignant Plasma Cell Neoplasms; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
MeSH terms: Leukemia; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow
      transplant helps stop the growth of cancer cells. It also helps stop the patient's immune
      system from rejecting the donor's stem cells. When the stem cells from a related or unrelated
      donor, that closely matches the patient's blood, are infused into the patient they may help
      the patient's bone marrow to make stem cells, red blood cells, white blood cells, and
      platelets.

      PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in
      treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the survival of allogeneic bone marrow transplantation using closely matched
           related and unrelated donors in patients with malignant or nonmalignant hematological
           disorders.

        -  Determine the incidence and severity of acute and chronic graft versus host disease with
           this treatment regimen in these patients.

        -  Determine the relapse rates with this treatment regimen in those patients with malignant
           disorders.

        -  Determine the incidence and severity of infectious complications associated with this
           treatment regimen in these patients.

      OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body
      radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.

      Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the
      beginning of the study. If CNS involvement is documented, patients receive a second dose of
      methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses.
      Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week
      for 12 weeks after transplant.

      Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant.
      Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant.

      Patients are followed once a week for 3 months, and then monthly for 1 year.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.
    

Intervention name(s): cyclophosphamide; TBI
Intervention type(s): Drug; Radiation
Intervention description(s): Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5); FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy.
Intervention MeSH terms: Cyclophosphamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent childhood acute lymphoblastic leukemia; refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia; recurrent childhood acute myeloid leukemia; recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; refractory chronic lymphocytic leukemia; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia in remission; childhood acute lymphoblastic leukemia in remission; polycythemia vera; primary myelofibrosis; essential thrombocythemia; refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; refractory cytopenia with multilineage dysplasia; chronic eosinophilic leukemia; chronic neutrophilic leukemia; atypical chronic myeloid leukemia, BCR-ABL1 negative; myelodysplastic/myeloproliferative neoplasm, 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); childhood myelodysplastic syndromes