Peripheral Stem Cell Transplant in Treating Patients With High-Risk Leukemia
Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic/Myeloproliferative Diseases
About this trial
This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring essential thrombocythemia, polycythemia vera, blastic phase chronic myelogenous leukemia, secondary myelodysplastic syndromes, previously treated myelodysplastic syndromes, adult acute myeloid leukemia in remission, childhood acute myeloid leukemia in remission, de novo myelodysplastic syndromes, secondary acute myeloid leukemia, accelerated phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, childhood acute lymphoblastic leukemia in remission, recurrent adult acute myeloid leukemia, relapsing chronic myelogenous leukemia, recurrent childhood acute myeloid leukemia, chronic idiopathic myelofibrosis, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, 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: High-risk myelodysplastic syndromes (MDS), meeting 1 of the following criteria: Transformation to acute leukemia defined by at least 15% blasts Secondary to prior treatment with chemotherapy and/or radiotherapy Presence of complex cytogenetics (at least 3 karyotypic abnormalities) Monosomy or deletion of chromosome 7 Acute myeloid leukemia (AML), meeting 1 of the following criteria : High-risk AML in first remission and meeting 1 of the following criteria: At least 3 karyotypic abnormalities Monosomy or deletion of chromosome 5 or 7 = 11q23 chromosomal abnormality Prior diagnosis of MDS Received prior radiotherapy or chemotherapy In second or subsequent remission Primary induction failure or partial remission Untested or sensitive relapse Chronic myelogenous leukemia, meeting 1 of the following criteria: Blast crisis Accelerated phase disease that has failed prior treatment with imatinib mesylate, defined as a failure to achieve hematologic response after 3 months of standard dose (600 mg/day) therapy or disease progression on therapy Myeloproliferative disease The following diagnoses are eligible: Agnogenic myeloid metaplasia Essential thrombocythemia Polycythemia vera Must have evidence of transformation to acute leukemia Acute lymphocytic leukemia (ALL), meeting 1 of the following criteria: High-risk ALL in first remission defined by 1 of the following: t(9;22) or 11q23 chromosomal abnormality Complete response at least 4 weeks after induction therapy OR requiring at least 2 induction regimens Second or subsequent remission No relapsed leukemia refractory to appropriate salvage therapy Availability of an HLA-mismatched family donor Donor age 75 or under No better donor alternative (i.e., HLA-matched related or unrelated stem cell donor) is available PATIENT CHARACTERISTICS: Age 10 to 50 Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic See Disease Characteristics Hepatic Bilirubin no greater than 4 mg/dL Transaminases no greater than 3 times upper limit of normal Renal Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular LVEF at least 40% Pulmonary DLCO at least 65% of predicted Other Not pregnant Negative pregnancy test HIV negative No other prior malignancy except basal cell or squamous cell skin cancer or a remote history of cancer now considered cured No major organ dysfunction that would preclude transplantation No major anticipated illness or organ failure that would preclude transplantation No severe psychiatric illness or mental deficiency that would preclude giving informed consent or complying with study No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy See Disease Characteristics Surgery Not specified
Sites / Locations
- NIH - Warren Grant Magnuson Clinical Center