Lymphoma, Non-Hodgkin Clinical Trial in Saint Louis MO
Have you or your loved ones been diagnosed with lymphoma, non-hodgkin?
You may be eligible to participate in a lymphoma, non-hodgkin clinical trial.
Have you or your loved ones been diagnosed with lymphoma, non-hodgkin? You may be eligible to participate in a lymphoma, non-hodgkin clinical trial.
Details for the study
Inclusion Criteria - Age 18 to 70 years. - Histologically proven non-Hodgkin's lymphoma - High risk disease including at least one of the following: - Relapsed or refractory disease - Transformed lymphoma - Aggressive T-cell lymphoma - Failure to achieve completed remission (CR) following Auto SCT - Less than a 20% chance of event-free survival from autologous transplant determined by the treating physician and the Principal Investigator - ECOG performance status < or = 2 - Underwent Autologous SCT 60-120 days prior to registration including: - BEAM conditioning (BCNU: 300 mg/m2 IV day -7, Etoposide: 100 mg/m2 IV BID days -6,-5,-4,-3, Cytarabine: 100 mg/m2 IV BID days -6,-5,-4,-3, Melphalan: 140 mg/m2 IV day -2) - Minimum of 2 x 106 CD34+ cells/kg infused - Full hematologic recovery following Auto HCT including: - Absolute neutrophil count (ANC) >1000 µl - Platelet count of ≥50,000 µl independent of transfusion for >7 days - Available matched related or unrelated donor. Selected donor must be a complete match or have only a single antigen mismatch. - Women of child-bearing potential and sexually active males must use an accepted and effective method of birth control. - Bone marrow comprising of < 10% lymphoma on most recent biopsy/aspiration (within 9 months of Allo transplant; may have been performed prior to autologous transplant). - Serum bilirubin < or = 2 x the institutional ULN - Serum creatinine < or = 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula - Estimated Creatinine Clearance = (140 age)X WT(kg) X 0.85 if female 72X serum creatinine(mg/dl). - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria - Prior autologous or allogeneic hematopoietic cell transplantation (other than autologous SCT 60-120 days prior to registration) - Prior radioimmunotherapy - Known or suspected progressive disease following autologous SCT - Additional treatment for NHL administered from time of autologous SCT through registration - Pregnant or breast-feeding women (due to the known birth defects association with the treatments used in this study) - Human immunodeficiency virus (HIV)-positive (the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population.) - Any prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patients has been disease-free for five years. - Active infection requiring oral or intravenous antibiotics. Inclusion of Women and Minorities -Both men and women and members of all races and ethnic groups are eligible for this trial.