Pilot Study of Donor Th2 Cells for the Prevention of Graft-Versus-Host Disease in the Setting of Non-Myeloablative, HLA-Matched Allogeneic Peripheral Blood Stem Cell Transplantation

Date de début de l'étude : 20 juillet 1999

INCLUSION CRITERIA - Patient: Patients with lymphoid malignancy and leukemia (including myelodysplasia) are candidates for this study. The following diagnoses and ages will be considered: Chronic Lymphocytic Leukemia, Age 18-75 Relapse Post-fludarabine, or Non-CR after Salvage Regimen Hodgkin's and Non-Hodgkin's Lymphoma (all types, including Mantle Cell Lymphoma), Age 18-75 Primary Treatment Failure, or Relapse after AutoSCT, or Non-CR after Salvage Regimen Multiple Myeloma, Age 18-75 Primary Treatment Failure, or Relapse after AutoSCT, or Non-CR after Salvage Regimen Acute Myelogenous Leukemia, Age 18-75 In CR #1, 2, or 3 Any Relapse with less than 10% blasts (marrow and blood) Acute Lymphocytic Leukemia, Age 18-75 In Complete Remission #2 In Complete Remission #3 Any Relapse with less than 10% blast (marrow and blood). Myelodysplastic Syndrome, Age 18-75 RAEB RAEB-T (if blasts are less than 10% in marrow and blood after induction chemotherapy) Chronic Myelogenous Leukemia, Age 18-75 Chronic Phase CML Accelerated Phase CML Patient age of at least 18 and not greater than 75 years of age. Availability of 6/6 antigen (A, B, and DR) HLA-matched sibling donor. Karnofsky performance status of greater than or equal to 70%. Life expectancy greater than 3 months. Serum bilirubin less than 2.5 mg/dL, and serum ALT and AST values less than or equal to 2.5 times the upper limit of normal. Values above these levels may be accepted, at the discretion of the PI or study chairman, if such elevations are thought to be due to tumor involvement by the lymphoid malignancy. If these values do not normalize during the induction chemotherapy, such patients will not be eligible for the transplant phase of the protocol, and will thus be taken off study. Creatinine clearance greater than or equal to 60 ml/min or serum creatinine of less than or equal to 1.5 mg/dl. DLCO greater than 50% of predicted. Left ventricular ejection fraction of greater than or equal to 45% by MUGA or ECHO. Ability to give informed consent. Durable power of attorney form completed. INCLUSION CRITERIA - Donor: Must be sibling, matched with recipient at 6/6 of the HLA loci (A, B, and DR). Adequate venous access for peripheral apheresis, or consent to use a temporary central venous catheter for apheresis. Must be at least 12 years of age. Ability to give informed consent. For donors under 18 years of age, an assent form must be completed. EXCLUSION CRITERIA - Patient: Infection that is not responding to anti-microbial therapy. Active CNS involvement by tumor. HIV positive (due to unacceptable risk after allogeneic transplantation). Hepatitis B or C surface antigen positive. Lactating or pregnant females (due to risk to fetus or newborn). History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent (as determined by principal investigator or study chairman). EXCLUSION CRITERIA - Donor: History of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent. History of hypertension that is not controlled by medication, stroke, or severe heart disease. Individuals with symptomatic angina, or a history of coronary artery bypass grafting or angioplasty will be considered to have severe heart disease, and thus will not be eligible to be a donor. Anemia (Hb less than 11 gm/dl) or thrombocytopenia (PLT less than 100,000 per ul). Lactating or pregnant females. HIV positive. Hepatitis B or C antigen positive.