Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
Condition: Chronic Myeloproliferative Disorders; Graft Versus Host Disease; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases; Precancerous/Nonmalignant Condition
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Precancerous Conditions; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Graft vs Host Disease; Syndrome
Intervention: busulfan; cyclophosphamide; cyclosporine; etoposide; fludarabine phosphate; melphalan; methotrexate; mycophenolate mofetil; sirolimus; tacrolimus; allogeneic hematopoietic stem cell transplantation; peripheral blood stem cell transplantation; total-body irradiation
Intervention MeSH terms: Cyclosporine; Sirolimus; Mycophenolic Acid; Cyclophosphamide; Melphalan; Busulfan; Methotrexate; Fludarabine; Fludarabine phosphate; Etoposide; Tacrolimus; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 0 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: graft versus host disease; recurrent adult acute lymphoblastic leukemia; recurrent childhood acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia; untreated childhood acute lymphoblastic leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; refractory anemia with excess blasts in transformation; refractory anemia with excess blasts; atypical chronic myeloid leukemia; chronic myelomonocytic leukemia; juvenile myelomonocytic leukemia; myelodysplastic/myeloproliferative disease, unclassifiable; recurrent adult acute myeloid leukemia; recurrent childhood acute myeloid leukemia; adult acute myeloid leukemia in remission; childhood acute myeloid leukemia in remission; secondary acute myeloid leukemia; 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; blastic phase chronic myelogenous leukemia; childhood chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; chronic eosinophilic leukemia; chronic idiopathic myelofibrosis; chronic neutrophilic leukemia; essential thrombocythemia; polycythemia vera; Waldenstrom macroglobulinemia; 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 immunoblastic large cell lymphoma; recurrent adult lymphoblastic 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 small lymphocytic lymphoma; splenic marginal zone lymphoma; recurrent childhood grade III lymphomatoid granulomatosis; childhood nasal type extranodal NK/T-cell lymphoma; recurrent childhood large cell lymphoma; childhood diffuse large cell lymphoma; childhood immunoblastic large cell lymphoma; recurrent childhood lymphoblastic lymphoma; Burkitt lymphoma; recurrent childhood small noncleaved cell lymphoma; anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; recurrent adult T-cell leukemia/lymphoma; recurrent adult grade III lymphomatoid granulomatosis; adult nasal type extranodal NK/T-cell lymphoma; recurrent adult Hodgkin lymphoma; recurrent/refractory childhood Hodgkin lymphoma; refractory chronic lymphocytic leukemia; refractory multiple myeloma; stage III multiple myeloma; aplastic anemia; paroxysmal nocturnal hemoglobinuria; adult acute lymphoblastic leukemia in remission; childhood acute lymphoblastic leukemia in remission; recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent mycosis fungoides/Sezary syndrome; stage II multiple myeloma

Summary:

      RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell
      transplant 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. 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. Sometimes the transplanted cells
      from a donor can make an immune response against the body's normal cells. Giving tacrolimus,
      methotrexate, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant
      may stop this from happening.

      PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works
      in treating patients with advanced hematologic cancer or other disorders.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of one of the following:

               -  Acute lymphocytic leukemia (ALL), meeting one of the following criteria:

                    -  In first relapse or beyond

                    -  High-risk ALL, defined by any of the following:

                         -  Hypoploidy (≤ 44 chromosomes)

                         -  Pseudodiploidy with translocations or molecular evidence of t(9;22),
                            11q23, or t(8;14), excluding B-cell ALL

                         -  Elevated WBC at presentation (WBC > 20,000/mm³ [for patients > 18 years
                            of age]; WBC > 200,000/mm³ [for patients 12-18 years of age])

               -  Acute myeloid leukemia (AML), meeting one of the following criteria:

                    -  In first complete remission

                    -  Failed to achieve remission

                    -  In first relapse or beyond

                    -  Secondary AML (> 30% blasts in marrow aspirate)

                         -  Should receive induction chemotherapy to obtain remission, if possible,
                            before transplant

               -  Chronic myelogenous leukemia, meeting one of the following criteria:

                    -  In first or second chronic phase or accelerated phase

                    -  In blast crisis, defined as > 30% promyelocytes plus blasts in the bone
                       marrow

               -  Myelodysplastic syndromes, including any of the following:

                    -  Refractory anemia with excess blasts (RAEB)

                    -  Chronic myelomonocytic leukemia

                    -  RAEB in transformation

               -  Refractory non-Hodgkin lymphoma, chronic lymphocytic leukemia, Hodgkin lymphoma,
                  or multiple myeloma

                    -  Received and failed front-line therapy, high-dose therapy and autologous
                       stem cell transplantation, or salvage therapy

               -  Myeloproliferative disorders/myelofibrosis may be allowed on a case by case basis

               -  Severe aplastic anemia, paroxysmal nocturnal hemoglobinuria, or any other
                  hematologic disorder requiring transplantation

          -  Patients > 55 years of age with hematologic diseases treatable by allogeneic stem cell
             transplantation who are not eligible for IRB 99190 are eligible

          -  No uncontrolled CNS involvement of disease

          -  No matched (6/6) related donor available

          -  HLA-identical unrelated donor available

               -  HLA-phenotypically identical for HLA-A and HLA-B alleles and identical for DRB1
                  alleles by DNA typing for both class I and class II antigens

                    -  Allele mismatch for HLA class I (i.e., B 2701 vs B 2702) allowed if no
                       alternative donors

                    -  Allele mismatch for class II (i.e., DRB1 0401 vs 0402) or minor mismatch for
                       class I cross reactive group (CREG) (i.e., A 2 vs A 28) allowed in patients
                       ≤ 35 years of age requiring urgent transplant

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 50-100%

          -  Life expectancy > 8 weeks

          -  LVEF ≥ 45% at rest

          -  AST ≤ 2 times normal (unless liver function abnormality is due to underlying disease)

          -  Total bilirubin < 1.5 times normal (unless liver function abnormality is due to
             underlying disease)

          -  Creatinine ≤ 1.5 times normal OR creatinine clearance ≥ 60 mL/min

          -  DLCO ≥ 40% of predicted (corrected for hemoglobin)

          -  No coexisting medical problem that would significantly increase the risk of the
             transplant procedure

          -  HIV negative

          -  Not pregnant

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics