Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant
Leukemia, Lymphoma, Lymphoproliferative Disorder
About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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), juvenile myelomonocytic leukemia, prolymphocytic leukemia, recurrent adult acute myeloid leukemia, recurrent adult T-cell leukemia/lymphoma, recurrent childhood acute myeloid leukemia, refractory chronic lymphocytic leukemia, recurrent adult Hodgkin 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 grade III lymphomatoid granulomatosis, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent childhood grade III lymphomatoid granulomatosis, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent mycosis fungoides/Sezary syndrome, 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, recurrent/refractory childhood Hodgkin lymphoma, childhood diffuse large cell lymphoma, childhood grade III lymphomatoid granulomatosis, childhood immunoblastic large cell lymphoma, childhood nasal type extranodal NK/T-cell lymphoma, post-transplant lymphoproliferative disorder, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, childhood myelodysplastic syndromes, recurrent childhood anaplastic large cell lymphoma, adult acute myelomonocytic leukemia (M4), childhood acute myelomonocytic leukemia (M4), adult acute minimally differentiated myeloid leukemia (M0), childhood acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), childhood acute myeloblastic leukemia with maturation (M2), adult acute promyelocytic leukemia (M3), childhood acute promyelocytic leukemia (M3), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), childhood acute monoblastic leukemia (M5a), childhood acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), childhood acute erythroleukemia (M6), adult acute megakaryoblastic leukemia (M7), childhood acute megakaryocytic leukemia (M7), childhood Burkitt lymphoma, atypical chronic myeloid leukemia, BCR-ABL1 negative, chronic myelomonocytic leukemia, cutaneous B-cell non-Hodgkin lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, myelodysplastic/myeloproliferative neoplasm, unclassifiable
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed hematologic malignancies:
Chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL)
- Absolute lymphocytosis of > 5,000/μL
Lymphocytes must appear morphologically mature with < 55% prolymphocytes (CLL)
- Patients with > 55% prolymphocytes are considered as having PLL
- Lymphocyte phenotype with expression of CD20, CD19, and CD5 (CLL)
Non-Hodgkin lymphoma
- Any WHO classification of histologic subtype
- Core biopsies acceptable for primary diagnosis and immunophenotyping
- Bone marrow biopsies as sole means of diagnosis not allowed for follicular lymphoma
Hodgkin lymphoma
- Any WHO classification of histologic subtype
- Core biopsies acceptable for primary diagnosis and immunophenotyping
- Bone marrow biopsy is required
Multiple myeloma
- Patients must have active disease requiring treatment (Durie-Salmon stage I-III)
Acute myeloid leukemia
- Must have < 10% bone marrow blasts and no circulating blasts
Myelodysplastic syndrome (MDS)
- MDS as define by WHO criteria
- Must have < 10% marrow blasts
Relapsed or progressive disease or myelodysplasia ≥ 6 months after prior high-dose chemotherapy with autologous hematopoietic cell support
- Prior syngeneic transplantation allowed
Healthy donor meeting one of the following criteria:
HLA-identical sibling (6/6)
- Serologic typing for class I (A, B) and molecular typing for class II (DRB1) required
8/8 matched-unrelated donor
- Molecular identity at HLA A, B, C, and DRB1 by high-resolution typing required
- No syngeneic donors
PATIENT CHARACTERISTICS:
- Creatinine clearance ≥ 40 mL/min
- Total bilirubin ≤ 2 mg/dL
- AST ≤ 3 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- DLCO ≥ 40% with no symptomatic pulmonary disease
- LVEF ≥ 30% by MUGA or ECHO
- No uncontrolled diabetes mellitus or active serious infection
- No known hypersensitivity to E.coli-derived products
- No HIV infection
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks should elapse between prior standard cytotoxic chemotherapy, radiation therapy, or surgery and the planned start of the preparative regimen on day -7
Sites / Locations
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- Greenebaum Cancer Center at University of Maryland Medical Center
- Union Hospital of Cecil County
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Cancer Institute of New Jersey at Cooper - Voorhees
- New York Weill Cornell Cancer Center at Cornell University
- Wake Forest University Comprehensive Cancer Center
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment
Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60. Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover. Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks. Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years.