Cellular Adoptive Immunotherapy in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes That Relapsed After Donor Stem Cell Transplant
Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, secondary acute myeloid leukemia, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, 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), de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, T-cell adult acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, B-cell adult acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, childhood myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS: Undergoing allogeneic hematopoietic stem cell transplantation* from a major histocompatability complex (MHC)-identical related donor for 1 of the following: Primary refractory acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL) AML or ALL beyond first remission Therapy-related AML at any stage Philadelphia chromosome (bcr-abl)-positive p190-positive ALL at any stage Acute leukemia at any stage arising from myelodysplastic syndromes or myeloproliferative disorders, including any of the following: Chronic myelomonocytic leukemia Chronic myelogenous leukemia Polycythemia vera Essential thrombocytosis Agnogenic myeloid metaplasia with myelofibrosis Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation NOTE: *Patients must be enrolled on study prior to undergoing transplantation Relapsed disease post-transplantation, as evidenced by 1 of the following criteria: Morphologic relapse, as defined by 1 or more of the following: Peripheral blasts in the absence of growth factor therapy Bone marrow blasts > 5% of nucleated cells Extramedullary chloroma or granulocytic sarcoma Flow cytometric relapse, as defined by the appearance of cells with abnormal immunophenotype consistent with leukemia relapse in the peripheral blood or bone marrow (detected before transplantation) Cytogenetic relapse, as defined by the appearance in 1 or more metaphases from bone marrow or peripheral blood cells of either a non-constitutional cytogenetic abnormality detected in at least 1 cytogenetic study performed before transplantation OR a new abnormality known to be associated with leukemia Molecular relapse, as defined by 1 of the following: 1 or more positive polymerase chain reaction (PCR) assays for clonotypic immunoglobulin heavy chain or T-cell receptor gene rearrangement in patients transplanted for B- or T-cell ALL respectively 1 or more positive post-transplantation reverse transcription PCR assays for p190 BCR-ABL mRNA fusion transcripts in patients transplanted for Philadelphia chromosome-positive p190-positive ALL No grade III or IV acute graft-versus-host disease (GVHD)** No extensive chronic GVHD** NOTE: **At time of post-transplant relapse PATIENT CHARACTERISTICS: Age 14 and over (patients < 14 years of age may be eligible if they are deemed to be of sufficient height and weight by the pediatric attending physician) Performance status Karnofsky 60-100% (at time of post-transplant relapse) Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No preexisting major nonhematopoietic organ toxicity ≥ grade 3 (at time of post-transplant relapse) PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Concurrent immunosuppressive steroid therapy for GVHD allowed provided both of the following are true: Able to taper steroid dose to < 0.5 mg/kg/day No increase of > 1 grade in acute GVHD OR progression of chronic GVHD within 14 days after dose change Radiotherapy Not specified Surgery Not specified
Sites / Locations
- Fred Hutchinson Cancer Research Center