NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring accelerated phase chronic myelogenous leukemia, chronic myelomonocytic leukemia, primary myelofibrosis, de novo myelodysplastic syndromes, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, refractory anemia with excess blasts, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, Waldenstrom macroglobulinemia, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, noncontiguous stage II adult Burkitt lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, recurrent adult Hodgkin lymphoma, adult acute myeloid leukemia in remission, secondary acute myeloid leukemia, recurrent childhood acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, childhood acute lymphoblastic leukemia in remission, adult acute lymphoblastic leukemia in remission, noncontiguous stage II adult lymphoblastic lymphoma, refractory multiple myeloma, refractory anemia, refractory chronic lymphocytic leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, grade 1 follicular lymphoma, grade 2 follicular lymphoma, recurrent/refractory childhood Hodgkin lymphoma, recurrent adult acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, childhood acute myeloid leukemia in remission, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, 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
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of aplastic anemia Severe disease Failed at least 1 course of standard immunosuppressive regimen with cyclosporine and anti-thymocyte globulin OR Histologically confirmed hematologic malignancy including the following: Acute leukemia Any of the following types: Acute myeloid leukemia (AML) with antecedent myelodysplastic syndromes Secondary AML AML with high-risk cytogenetic abnormalities Acute lymphoblastic leukemia with high-risk cytogenetic abnormalities Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen OR In first remission at high risk of relapse Chronic myelogenous leukemia Chronic phase meeting at least 1 of the following criteria: Failed imatinib mesylate Failed interferon after at least 6 months of treatment with minimum of 21 million units of interferon per week Unable to tolerate interferon Accelerated phase (blasts less than 20%) Myeloproliferative and myelodysplastic syndromes Myelofibrosis (after splenectomy) Refractory anemia Refractory anemia with excess blasts Chronic myelomonocytic leukemia Lymphoproliferative disease Chronic lymphocytic leukemia Symptomatic disease after first-line chemotherapy Low-grade non-Hodgkin's lymphoma (recurrent or persistent) Symptomatic disease after first-line chemotherapy Multiple myeloma Progressive disease after autologous stem cell transplantation Waldenstrom's macroglobulinemia Failed 1 standard regimen Non-Hodgkin's lymphoma meeting the following criteria: Intermediate or high grade Controlled and chemosensitive disease First remission lymphoblastic or small non-cleaved cell lymphoma at high risk of relapse Hodgkin's lymphoma Relapsed and chemosensitive disease Not eligible for standard myeloablative allogeneic stem cell transplantation Availability of any of the following donor types: Related donor matched at 5 or 6 HLA antigens (A, B, DR) Unrelated donor fully matched by molecular analysis at A, B, DRB1, and DQB1 loci Single antigen mismatch at C allowed Cord blood that is 4, 5, or 6 match with recipient HLA antigens (A, B, DR) NOTE: No syngeneic donors permitted No uncontrolled CNS disease (for hematologic malignancies) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age 4 to 75 (if related or unrelated donor peripheral blood or marrow transplantation) 4 to 60 (if unrelated cord blood transplantation) Performance status Karnofsky > 50% Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin less than 3 times normal Alkaline phosphatase less than 3 times normal AST/ALT less than 3 times normal No Child's class B or C liver failure Renal Creatinine clearance greater than 40 mL/min Cardiovascular Cardiac ventricular ejection fraction at least 35% by MUGA No cardiovascular disease Pulmonary DLCO at least 40% of predicted, corrected for hemoglobin and/or alveolar ventilation Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV antibody negative No uncontrolled diabetes mellitus No active serious infection No other disease that would preclude study therapy No other concurrent malignancy except non-melanoma skin cancer No concurrent serious psychiatric illness PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics patients may have received a prior autologous blood or marrow transplantation (BMT) At least 6 months since prior allogeneic BMT Chemotherapy See Disease Characteristics At least 2 weeks since prior chemotherapy, radiation or surgery Endocrine therapy Not specified Radiotherapy At least 2 weeks since prior radiotherapy Surgery At least 2 weeks since prior surgery
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Experimental
All patients
All patients enrolled on study