HLA-Matched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed by T Cell Add-Back for Hematological Malignancies

Fecha de inicio: 27 de marzo de 1997

INCLUSION CRITERIA-PATIENT: Ages 10 to 55 years. Chronic myelogenous leukemia, any of these categories: chronic phase, accelerated phase of blast transformation. Acute lymphoblastic leukemia, any of these categories: Adults (greater than 18 years) in first remission with high risk features (presenting leukocyte count greater than 100,000 per cu mm, Karyotypes t9;22, t4, t19, t11, biphenotypic leukemia). All second remissions, primary induction failure, partially responding or untreated relapse. Acute myelogenous leukemia (AML): AML in first remission Except AML with good risk karyotypes: AML M3 (t15;17), AML M4Eo (inv 16), AML t(8;21). All AML in second or subsequent remission, primary induction failure and resistant relapse. Myelodysplastic syndromes, any of these categories: refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia. Multiple myeloma following initial disease control with chemotherapy. Chronic lymphocytic leukemia (CLL) and prolymphocytic leukemia, in remission or partial remission following fludarabine treatment. Richter transformation of CLL. No major organ dysfunction precluding transplantation. DLCO greater than 65 percent predicted. Left ventricular ejection fraction: greater than 40 percent predicted. ECOG performance status of 0 or 1. Informed consent given. Informed consent from both parents for minors. Women of childbearing age with a negative pregnancy test may participate. EXCLUSION CRITERIA: Pregnant. Age greater than 55 or less than 10. ECOG performance status of 2 or more. Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible. Major anticipated illness or organ failure incompatible with survival from BMT. DLCO less than 65% predicted. Left ventricular ejection fraction: less than 40% predicted. Serum creatinine greater than 3 mg/dl. Serum bilirubin greater than 4 mg/dl. Transaminases greater than 3 x upper limit of normal. HIV positive. History of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up (patient). INCLUSION CRITERIA-DONOR: HLA 6/6 or 5/6 matched sibling donor. Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke). Informed consent given. EXCLUSION CRITERIA - DONOR: Pregnant. Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible. Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of stroke, thrombocytopenia). HIV positive.