SWOG clinical trial number
S0016
A Phase III Trial of CHOP vs. CHOP + Rituximab vs. CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
100% Accrual
Accrual
100%
Closed
100% Accrual
Accrual
100%
Published
Abbreviated Title
NON-HODGKIN'S: CHOP/rituximab vs. CHOP/tositumomab
Treatment
Rituximab
Tositumomab
CHOP
All patients must have previously untreated follicular Non-Hodgkin's lymphoma (Grade I, II, or III) that expresses the CD20 antigen; patients must have Stage III, Stage IV or bulky Stage II extent of disease by the Ann Arbor classification; patients must have bidimensionally measurable disease documented w/in 28 days of registration; patients must have a bilateral or unilateral bone marrow aspirate and biopsy performed w/in 42 days of registration; patients must have a chest x-ray or CT of chest and a CT of abdomen/pelvis w/in 28 days prior to registration; patients must have a beta-2 microglobulin performed w/in 28 days prior to registration; patients must not have CNS involvement by lymphoma; patients must not have received prior chemo or RT for lymphoma & no prior monoclonal antibodies for malignant disease; patients must not have a history of hypersensitivity to iodine; patients must not have a history of impaired cardiac status; if cardiac history is questionable, a MUGA scan is required; patients known to be HIV+ are not eligible; pregnant or nursing women are not eligible; no prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years; institutions must submit documents and obtain approval from GlaxoSmithKline prior to registration (institutions who were previously approved by Coulter for S9911 need not repeat the approval process; however, documents must still be submitted to GlaxoSmithKline); >= 18 years of age; granulocytes > 1500/ul; platelets > 100,000/ul; < 5000 circulating lymphoid cells per mcL on differential; all patients must submit a pretreatment marrow submission for t(14;18)/bcl2 assessment; all patients must agree to the serum sample submission schedule for HAMA testing.
2016
Molecular characterization of follicular lymphoma patients enrolled on SWOG S0016 using FFPE Chromosomal Genomic Array Testing
X Qu;H Li;O Press;L Rimsza;R Braziel;M Leblanc;E Hsi;S Smith;J Friedberg;M Fang Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics ( March 8-12, 2016, Tampa, FL), poster, abst #141 (https://acmg.expoplanner.com/index.cfm?do=expomap.sess&event_id=7&sessi…)
2014
Elevated MIG, IL-2R and IL1-R1 are associated with early progression in in Follicular Lymphoma
M Mir;M Maurer;SC Ziesmer;S Slager;T Habermann;BK Link;T Witzig;J Friedberg;O Press;M Leblanc;JR Cerhan;A Novak;S Ansell ASH Lymphoma Biology Conference (August 10-13, Colorado Springs, CO), poster presentation;
2012
A phase III randomized intergroup trial (S0016) comparing CHOP + rituximab vs. CHOP + iodine-131-tositumomab for front-line treatment of follicular lymphoma: subset analyses and comparison of prognostic models
OW Press;J Unger;M Leblanc;L Rimsza;J Friedberg;M Czuczman;M Kaminski;RM Braziel;C Spier;DG Maloney;BD Cheson;TP Miller;RI Fisher J Clin Oncol 30 (suppl; abstr 8001); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), oral presentation;
2008
Effect of rituximab on residence time of I-131 tositumomab consolidation therapy in patients (pts) with non-Hodgkin's lymphoma (NHL): analysis of SWOG clinical trials
J Schaefer-Cutillo;V Chengazi;D Peterson;D Maloney;K Kibler;EM Cebula;S Bernstein;F Young;O Press;LM Rimsza;RI Fisher;JW Friedberg Blood 112(11):697-698, Abst. #2000
