Cyclophosphamide and/or Mycophenolate Mofetil With or Without Tacrolimus in Treating Patients Who Are Undergoing a Donor Bone Marrow or Peripheral Stem Cell Transplant for Hematologic Cancer
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia
About this trial
This is an interventional supportive care trial for Chronic Myeloproliferative Disorders focused on measuring graft versus host disease, 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), adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, chronic idiopathic myelofibrosis, chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, previously treated myelodysplastic syndromes, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, stage II multiple myeloma, stage III adult Hodgkin lymphoma, stage III chronic lymphocytic leukemia, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III multiple myeloma, stage III small lymphocytic lymphoma, stage IV adult Hodgkin lymphoma, stage IV chronic lymphocytic leukemia, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV small lymphocytic lymphoma, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, refractory cytopenia with multilineage dysplasia, primary systemic amyloidosis, de novo myelodysplastic syndromes, secondary acute myeloid leukemia, secondary myelodysplastic syndromes, atypical chronic myeloid leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following hematologic malignancies: Stage II or III multiple myeloma Amyloidosis Myelofibrosis with ≥ 2 of the following high-risk features: Over 55 years of age Hemoglobin < 10 g/dL WBC < 3,000/mm^3 OR > 10,000/mm^3 Platelet count < 100,000/mm^3 Cytogenetic abnormalities Mycosis fungoides, meeting 1 of the following criteria: Stage IIB or III disease with evidence of histologic conversion to an aggressive lymphoma Must demonstrate chemosensitivity Stage IV disease Paroxysmal nocturnal hemoglobinuria Not meeting criteria for other bone marrow transplantation (BMT) or treatment studies Diagnosis of 1 of the following hematologic malignancies, for which patient is not eligible for potentially curative allogeneic BMT due to end-organ dysfunction, age 65 to 75, or the amount of prior chemotherapy: Acute myeloid or acute lymphoblastic leukemia High-risk disease in first or second (or further) complete remission Relapsed aggressive non-Hodgkin's lymphoma Not eligible for autologous or standard allogeneic BMT Hodgkin's lymphoma in second or further complete or partial remission Not eligible for autologous or standard allogeneic BMT Myelodysplastic syndromes or myelodysplastic/myeloproliferative diseases Any of the following subtypes: Refractory anemia with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia Any morphologic subtype with multiple chromosomal abnormalities Any subset with life-threatening cytopenias in all 3 cell lines, defined as platelet count ≤ 20,000/mm^3, absolute neutrophil count ≤ 500/mm^3, and reticulocyte count ≤ 50,000/mm^3 Meets both of the following criteria: Less than 20% blasts by bone marrow biopsy Not eligible for standard allogeneic BMT No refractory anemia with ringed sideroblasts No 5q syndrome Stage III or IV chronic lymphocytic leukemia Not meeting criteria for other BMT studies Chronic myelogenous leukemia in first or second chronic phase Not meeting criteria for other BMT studies or treatment Stage III or IV indolent small lymphocytic or follicular lymphoma Not eligible for autologous or standard allogeneic BMT or other active protocols at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Must have an HLA-identical related donor available PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin ≤ 3.0 mg/dL AST ≤ 175 U/L ALT ≤ 200 U/L Renal Creatinine ≤ 3.0 mg/dL Cardiovascular LVEF ≥ 30% Pulmonary FEV_1 ≥ 40% predicted Forced vital capacity ≥ 40% predicted Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Chemotherapy See Disease Characteristics
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins