Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies
Lymphoma, Leukemia, Multiple Myeloma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Non-Myeloablative, T-cell Depleted, Mismatched, Stem Cell Transplantation
Eligibility Criteria
Inclusion Criteria: Disease Status: NHL, HD, MM that are chemorefractory or relapsed; CLL that is Rai stage III or IV, or lymphocyte doubling time of 6 months, or stage I/II resistant to > 2 cycles of chemotherapy regimens; CML in accelerated or blast phase; MDS with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematological disorders where allogeneic transplant is appropriate and the risk of conventional transplantation is considered to be unacceptably high. estimated disease free survival of less than one year ECOG performance status of 0, 1, or 2 HLA 1 to 3 mismatched (at A, B, DR loci) related donor Exclusion Criteria: Cardiac disease: symptomatic congestive heart failure, ejection fraction of < 45%, active angina pectoris or uncontrolled hypertension. Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of < 50% Renal disease: serum creatinine > 2.0 mg/dl or creatinine clearance < 50 ml/min Hepatic disease: serum bilirubin > 2.0 mg/dl or alkaline phosphate, SGPT or SGOT > 3 x normal Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation HIV antibody or Hepatitis B surface antigen positivity Uncontrolled infection Presence of HAMA or HAHA in patient previously treated with monoclonal antibody therapy or who have received a product in which the preparation involved a monoclonal antibody affinity step
Sites / Locations
- Massachusetts General Hospital