Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia
About this trial
This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring 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
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Regimen I
Regimen II
Regimen III
Regimen IV
Regimen V
Regimen VI
Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.