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

Closed
Phase
III
Accrual
100%
Published
Abbreviated Title
NON-HODGKIN'S: CHOP/rituximab vs. CHOP/tositumomab
Activated
03/01/2001
Closed
10/02/2008
Participants
NCORP, Members, Medical Oncologists, Radiation Oncologists, Pathologists, CALGB, CTSU, Affiliates

Research committees

Lymphoma

Treatment

Rituximab Tositumomab CHOP

Eligibility Criteria Expand/Collapse

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.

Publication Information Expand/Collapse

2018

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

Impact of histologic grading on survival in the SWOG S0016 follicular lymphoma cohort

L Rimsza;H Li;R Braziel;C Spier;D Persky;J Dunlap;M Leblanc;N Bartlett;JP Leonard;SM Smith;O Press;J Friedberg Haematologica Feb 22 [Epub ahead of print]

PMid: PMID29472351

Continued excellent outcomes in previously untreated follicular lymphoma patients after treatment with CHOP plus Rituximab or CHOP plus 131Iodine-Tositumomab - long term follow-up of phase III randomized study SWOG-S0016 (https://www.ncbi.nlm.nih.gov/pubmed/29356608) PMID29356608

M Shadman;H Li;L Rimsza;JP Leonard;MS Kaminski;R Braziel;C Spier;AK Gopal;DG Maloney;BD Cheson;S Dakhil;M LeBlanc;SM Smith;RI Fisher;JW Friedberg;OW Press Journal of Clinical Oncology, Mar 1;36(7):697-703; Jan 22 [Epub ahead of print]

PMid: PMID29356608

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

2017

Genomic Alterations Important for the Prognosis in Patients with Follicular Lymphoma Treated on SWOG Study S0016

X Qu;H Li;O Press;L Rimsza;R Braziel;M LeBlanc;E Hsi;JP Leonard;S Smith;JW Friedberg;M Fang American Society of Hematology Annual Meeting (December 9-12, 2017, Atlanta, GA), poster

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…)

Continued excellent outcomes in previously untreated follicular lymphoma patients after treatment with CHOP plus rituximab or CHOP plus (131) iodine-tositumomab - long term follow-up of phase III randomized study SWOG S0016

M Shadman;H Li;L Rimsza;JP Leonard;M Kaminski;R Braziel;C Spier;A Gopal;D Maloney;B Cheson;S Dakhil;M Leblanc;SM Smith;RI Fisher;JW Friedberg;O Press Blood 128:616;American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), oral

Recommendations for clinical trial development in follicular lymphoma

K Maddocks;P Barr;B Cheson;RF Little;L Baizer;B Kahl;JP Leonard;N Fowler;LI Gordon;B Link;JW Friedberg Journal of the National Cancer Institute Dec 31;109(3)pii: djw255

PMid: PMID28040699 | PMC number: n/a - Review

2015

Low serum vitamin D levels are associated with inferior survival in follicular lymphoma: a prospective evaluation in SWOG and LYSA studies

J Kelly;G Salles;B Goldman;RI Fisher;O Casasnovas;O Press;DG Maloney;P Soubeyran;L Rimsza;M Leblanc;H Tilly;J Friedberg Journal of Clinical Oncology May 1;33(13):1482-1490

PMid: PMID25823738 | PMC number: PMC4404425

Elevated serum levels of IL-2R, IL-1RA and CXCL9 are associated with a poor prognosis in follicular lymphoma

M Mir;MJ Mauer;SC Ziesmer;S Slager;T Habermann;W Macon;BK Link;S Syrbu;T Witzig;J Friedberg;O Press;M Leblanc;J Cerhan;A Novak;S Ansell Blood Feb 5;125(6):992-998

PMid: PMID25422100 | PMC number: PMC4319239

Genomic alterations important for the prognosis in patients with follicular lymphoma treated on SWOG Study S0016

X Qu;H Li;OW Press;L Rimsza;R Braziel;M Leblanc;E Hsi;S Smith;J Friedberg;M Fang Blood 2015 126(23):2678; American Society of Hematology Annual Meeting (Dec 5-8, Orlando, FL), poster presentation;

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;

2013

A phase III randomized intergroup trial of CHOP chemotherapy plus rituximab compared to CHOP chemotherapy plus 131iodine-tositumomab for previously untreated follicular non-hodgkins lymphoma (SWOG S0016)

OW Press;JM Unger;L Rimsza;JW Friedberg;M LeBlanc;MS Czuczman;M Kaminski;RM Braziel;C Spier;AK Gopal;DG Maloney;B Cheson;S Dakhil;TP Miller;RI Fisher Journal of Clinical Oncology 31(3):314-320;

PMid: PMID23233710 | PMC number: PMC3732010

A comparative analysis of prognostic factor models for follicular lymphoma based on a phase III trial of CHOP-Rituximab vs CHOP + 131Iodine-Tositumomab

O Press;J Unger;L Rimsza;J Friedberg;M LeBlanc;M Czuczman;M Kaminski;R Braziel;C Spier;A Gopal;D Maloney;B Cheson;S Dakhil;T Miller;R Fisher Clinical Cancer Research 19(23):6624-32;

PMid: PMID24130072 | PMC number: PMC3872052

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;

Low serum vitamin D levels are associated with inferior survival in follicular lymphoma: a prospective evaluation and replication in SWOG and LYSA

JL Kelly;G Salles;B Goldman;R Fisher;O Casasnovas;O Press;D Maloney;P Soubeyran;L Rimsza;M Leblanc;H Tilly;J Friedberg Blood 120(21):abst.2712; American Society of Hematology, poster;

2011

A phase III randomized intergroup trial (SWOG S0016) of CHOP chemotherapy plus rituximab vs. CHOP chemotherapy plus iodine-131 for the treatment of newly diagnosed follicular non- hodgkin's lymphoma

O Press;J Unger;L Rimsza;J Friedberg;M Leblanc;M Czuczman;M Kaminski;R Braziel;D Maloney;B Cheson;TP Miller;RI Fisher Blood 118:abstract 98; American Society of Hematology Annual Meeting, oral

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

Other Clinical Trials

SWOG Clinical Trial Number
SWOG-7204/7205

Non-Hodgkin's Lymphoma CHOP vs. HOP Combination Chemotherapy for Remission Induction and COP vs. OAP Combination Chemotherapy for Maintenance

Research Committee(s)
Lymphoma
Activated
04/17/1972
Closed
09/10/1974
Closed
Phase
III
Published
SWOG Clinical Trial Number
SWOG-7426/7427
SWOG Clinical Trial Number
SWOG-7713/14