Selective T-Cell Depletion to Reduce GVHD (Patients) Receiving Stem Cell Tx to Treat Leukemia, Lymphoma or MDS
Graft vs Host Disease, Myelodysplastic Syndromes, Leukemia
About this trial
This is an interventional treatment trial for Graft vs Host Disease focused on measuring Peripheral Blood Stem Cell, Melphalan, Fludarabine, Donor Apheresis, Non-Myeloablative, MDS, Chronic Myeloid Leukemia, CML, Chronic Lymphocytic Leukemia, CLL, Lymphoma, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Mantle Cell Lymphoma, Acute Myelogenous Leukemia (AML), Chronic Myeloid Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Myelodysplasia (MDS), Acute Lymphoblastic Leukemia (ALL), Bone Marrow Transplant
Eligibility Criteria
- INCLUSION CRITERIA: PATIENT Ages 50-75 years Relapsed CML in chronic or accelerated phase after therapy with STI-571 (Gleevec) Acute lymphoblastic leukemia (ALL), all patients in complete or partial remission. Exceptions: T cell ALL Acute myelogenous leukemia (AML): AML in first complete or partial remission including AML secondary to chemotherapy or prior hematological disease such as myelodysplastic syndrome, and myeloproliferative disorder. Myelodysplastic syndromes: (1) refractory anemia with excess of blasts (RAEB), (2) refractory anemia with excess blasts in transformation (RAEBT), (3) MDS with poor risk cytogenetics defined by a complex karyotype (greater than or equal to three anomalies) or chromosome 7 abnormalities, (4) secondary MDS after prior cytotoxic or radiation therapy, or (5) chronic myelomonocytic leukemia (CMML) Chronic lymphocytic leukemia (CLL) and prolymphocytic leukemia, refractory to nucleoside analog therapy, with either progressive bulky disease or anemia (less than 10 g/dl) or thrombocytopenia (less than 100,000/microliter) not due to recent chemotherapy Mantle cell lymphoma Relapsed intermediate- or high-grade non-Hodgkin's lymphoma: (1) post autologous marrow or PBSC transplant, or (2) chemorefractory relapse. Exceptions: T cell NHL Relapse Hodgkin's disease: (1) post autologous marrow or PBSC transplant, or (2) chemorefractory relapse Low-grade follicular or small lymphocytic lymphoma: (1) relapsed following conventional chemotherapy, (2) relapsed following autologous marrow or PBSC transplant, or (3) chemoresistant disease Life expectancy greater than 3 months Ability to comprehend the investigational nature of the study and provide informed consent Availability of an HLA-identical family donor, 18 to 75 years old INCLUSION CRITERIA: DONOR HLA identical family donor, 18 to 75 years old Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke, no history of severe heart disease) Ability to comprehend the investigational nature of the study and provide informed consent EXCLUSION CRITERIA: RECIPIENT Pregnant or lactating Eastern Cooperative Oncology Group (ECOG) performance status of 3 or more Major anticipated illness or organ failure incompatible with survival from PBSC transplant Diffusion Capacity fir carbon monoxide (DLCO) less than 60% predicted Left ventricular ejection fraction less than 40%, or any angina. Absolute lymphocyte count less than 300/mm(3) Serum creatinine greater than 2.5 mg/dl Serum bilirubin greater than 4 mg/dl, transaminases greater than 5x upper limit of normal HIV positive Other malignant diseases liable to relapse or progress within 2 years EXCLUSION CRITERIA: DONOR Pregnant or lactating HIV positive. Donors who are positive for Hepatitis B Virus, Hepatitis C Virus or human t-cell lymphoma virus (HTLV) will be used at the discretion of the investigator and with appropriate consent of the recipient Donor unfit to receive G-CSF and undergo apheresis (uncontrolled hypertension, history of heart failure or unstable angina, platelet count less than 90,000/cu mm)
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
RFT5-SMPT-dgA Isolex system
RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin used in allogeneic stem cell transplantation (SCT) in older patients with hematologic malignancies using a graft manipulation process