T-Cell-Depleted Allogeneic Stem Cell Transplantation After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring prolymphocytic leukemia, accelerated phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, refractory chronic lymphocytic leukemia, de novo myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm, unclassifiable, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, secondary acute myeloid leukemia, recurrent adult Hodgkin lymphoma, refractory anemia with excess blasts, refractory multiple myeloma, primary myelofibrosis, 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 adult Burkitt lymphoma, recurrent mantle cell lymphoma, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, chronic myelomonocytic leukemia, polycythemia vera, essential thrombocythemia, stage II multiple myeloma, stage III multiple myeloma, 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)
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following hematologic malignancies: Acute myeloid leukemia (AML), meeting 1 of the following criteria: In first complete remission (CR1), meeting 1 of the following criteria: Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR), defined as 1 of the following: Complex karyotype [≥ 3 abnormalities] inv(3) or t(3;3) t(6;9) t(6;11) Monosomy 7 Trisomy 8, alone or with an abnormality other than t(8;21), t(9;11), inv(16), or t(16;16) t(11;19) (q23;p13.1) Failed to achieve CR after primary induction chemotherapy Secondary AML In second or subsequent remission (CR2 or greater) Acute lymphoblastic leukemia, meeting 1 of the following criteria: In CR1, meeting 1 of the following criteria: Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, FISH, or PCR, defined as the following: Translocations involving 11q23, t(9;22), or bcr-abl rearrangement Failed to achieve CR after primary induction chemotherapy In CR2, if CR1 was < 12 months In CR3 or greater Myelodysplastic syndromes (MDS) INT-2 or high-risk by International Prognostic Scoring System No MDS with Fanconi anemia Chronic myelogenous leukemia (CML), meeting 1 of the following criteria: Accelerated phase with treatment failure after imatinib mesylate Blast phase Myeloproliferative disorders, meeting 1 of the following criteria: Agnogenic myeloid metaplasia with adverse-risk features, meeting at least 2 of the following criteria: Hemoglobin < 10 g/dL or > 10g/dL if transfusion-dependent WBC < 4,000/mm^3 OR > 30,000/mm^3 OR requires cytoreductive therapy to maintain WBC < 30,000/mm^3 Abnormal cytogenetics, including +8, 12p- Polycythemia vera or essential thrombocythemia in transformation to secondary AML Myelodysplastic/myeloproliferative disease Chronic myelomonocytic leukemia Hodgkin's lymphoma or non-Hodgkin's lymphoma Refractory lymphoma with progressive disease during combination chemotherapy Relapse after OR ineligible for autologous stem cell transplantation (SCT) Chronic lymphocytic leukemia Treatment failure* after fludarabine, chlorambucil, and at least 1 other salvage regimen Prolymphocytic leukemia (PLL), meeting 1 of the following criteria: T-PLL Treatment failure* after alemtuzumab and at least 1 other regimen B-PLL Treatment failure* after fludarabine and at least 1 other salvage regimen Multiple myeloma, meeting 1 of the following criteria: Relapse after autologous SCT Plasma cell leukemia Adverse cytogenetics, defined as 1 of the following: del(13q) = 11q translocation NOTE: *Treatment failure is defined as relapse within 6 months OR failure to achieve remission Less than 10% blasts in bone marrow and no circulating blasts in peripheral blood for the following diagnoses: Primary or secondary leukemia Refractory anemia with excess blasts CML Other eligible diagnosis in transformation to acute leukemia Expected survival of approximately 1 year or less with conventional therapy No active CNS involvement by malignancy* Prior CNS involvement with no current evidence of CNS malignancy allowed NOTE: *Active CNS malignancy is defined by lymphoma: tumor mass on CT scan or leptomeningeal disease OR leukemia: blasts present on cerebrospinal fluid cytospin Availability of a donor who is a sibling, parent, or offspring who shares 1 full haplotype (HLA-A, -B, or -DR) Recipient and donor must have at least a 2-antigen disparity in either the host-versus-graft or graft-versus-host direction Parent or offspring donor who is mismatched for a single HLA antigen (i.e., 5/6 HLA) is allowed No sibling donor who is 6/6 HLA-matched OR mismatched for a single HLA antigen (i.e., 5/6 HLA) No unrelated donor identified in a prior or current National Marrow Donor Program registry search PATIENT CHARACTERISTICS: Age 18 to 55 Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy At least 3 months Hematopoietic See Disease Characteristics Absolute neutrophil count ≥ 1,000/mm^3* Platelet count ≥ 20,0000/mm^3* (without transfusion) NOTE: *Lower values may be accepted at the discretion of the principal investigator or study chairperson if due to bone marrow involvement by malignancy Hepatic ALT and AST ≤ 2.5 times upper limit of normal (ULN)* Bilirubin ≤ 2.5 times ULN* Unconjugated hyperbilirubinemia consistent with Gilbert's syndrome allowed No chronic active hepatitis B infection Hepatitis B core antibody positive allowed provided patient is surface antigen negative and has no evidence of active infection No hepatitis C viral infection Seronegative for anti-hepatitis C antibody and detectable hepatitis C viral RNA by reverse transcriptase-polymerase chain reaction assay NOTE: *Higher levels may be accepted at the discretion of the principle investigator or study chairperson if such elevations are due to liver involvement by malignancy Renal Creatinine ≤ 1.5 mg/dL OR Creatinine clearance ≥ 50 mL/min Cardiovascular LVEF ≥ 45% Pulmonary DLCO ≥ 50% of expected value (corrected for blood hemoglobin level and alveolar volume) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study participation HIV negative No active infection not responding to antimicrobial therapy No psychiatric disorder that would preclude study compliance or informed consent PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics At least 2 weeks since prior monoclonal antibody therapy Chemotherapy See Disease Characteristics At least 2 weeks since prior systemic chemotherapy Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other Recovered from all prior therapy No administration of tyrosine kinase (TK) inhibitors, including imatinib mesylate and dasatinib, during the conditioning regimen; TK inhibitor administration may resume 28 days after transplantation
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office