SWOG clinical trial number
E4494

Phase III Trial of CHOP versus CHOP and Chimeric Anti-CD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients with Diffuse Mixed, Diffuse Large Cell and Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma

Closed
Phase
Published
Abbreviated Title
NON-HODGKIN'S: CHOP vs CHOP + rituximab -> rituximab vs. observation
Activated
11/15/1999
Closed
07/12/2001
Participants
NCORP, Members, Medical Oncologists, Pathologists

Research committees

Lymphoma

Treatment

Cyclophosphamide Prednisone Vincristine Doxorubicin Rituximab CHOP

Eligibility Criteria Expand/Collapse

Histologically confirmed Non-Hodgkin's lymphoma Working Formulation groups F, G, and H (REAL classification B-cell
neoplasm, peripheral B-cell neoplasm, diffuse large cell lymphoma, or primary mediastinal B cell lymphoma); Stage I -
IV; no follicular; no mantle cell; no T-cell; CD20 and/or CD19 positive; measurable disease; <= 60 years of age;
granulocytes >= 1500/mm3; platelets >= 100,000/mm3; serum creatinine < 2.1 mg/dl or calculated creatinine clearance >= 60 ml/min; bilirubin <= 3.0 mg/dl; no previous cytotoxic chemotherapy, biological response modifier therapy,
radiotherapy, immunotherapy, radioimmunotherapy, or IDEC C2B8; prior treatment with corticosteroids OK; no concomitant malignancy; ECOG performance status of 0-3; no central nervous system involvement with lymphoma; no known HIV; no history of transformed lymphoma; no post-transplant proliferative disorder; no active heart disease; zinecard is contraindicated.

Publication Information Expand/Collapse

2022

Development of a Conditional Event-Free Survival Tool in Diffuse Large B-Cell Lymphoma

D Luan;Z Chen;L Jakobsen;M Maurer;T El-Galaly;L Nastoupil;J Cerhan;C Flowers;B Link;I Lossos;D Stephens;T Habermann;G Nowakowski;N Bartlett;J Friedberg;B Kahl;J Leonard;K Smedby;M Jerkeman;P Martin ASH Annual Meeting (Dec 10 thru 13, 2022, New Orleans, LA), oral

2020

Economic evaluations in NCI-sponsored network cancer clinical trials

VT Nghiem;R Vaidya;GH Lyman;DL Hershman;SD Ramsey;JM Unger Value in Health Dec;23(12):1653-1661. doi: 10.1016/j.jval.2020.08.2095. Epub 2020 Oct 9

PMid: PMID33248521 | PMC number: PMC8262264

2017

Patterns of growth factor usage and febrile neutropenia among older patients with diffuse large B-cell non-Hodgkin lymphoma treated with CHOP or R-CHOP: the Intergroup experience (CALGB 9793; ECOG-SWOG 4494)

VA Morrison;EA Weller;TM Habermann;S Li;RI Fisher;BD Cheson;BA Peterson Leukemia & Lymphoma Aug;58(8):1814-1822

PMid: PMID27967294 | PMC number: PMC5502834

2014

The role of body mass index in survival outcome for lymphoma patients: US intergroup experience

F Hong;TM Habermann;LI Gordon;H Hochster;R Gascoyne;VA Morrison;RI Fisher;NL Bartlett;PJ Stiff;BD Cheson;M Crump;SJ Horning;BS Kahl Annals of Oncology 25(3):669-674

PMid: PMID24567515; PMC4433526

2013

Elderly IPI (EIPI) in DLBCL pts age >60 treated with RCHOP: international validation study using data from RICOVER-60 (German High Grade Non-Hodgkin Lymphoma Study Group) and LNH 98-5 (Groupe D'Etude de Lymphome d'Adultes)

R Advani;F Hong;TM Habermann;BS Kahl;VA Morrison;EA Weller;G Varma;RI Fisher;BA Peterson;B Cheson;RD Gascoyne;SJ Horning;S Bousetta;B Coiffier;M Ziepert;M Pfreudschuh Hematological Oncology 31(suppl.1):abstr.#222, p.171; Int'l. Conference on Malignant Lymphoma (June 19-22, 2013, Lugano, Switzerland), poster presentation;

Improved risk stratification with addition of male sex (S) to the elderly international prognostic index (S-EIPI) for DLBCL patients > 60 years treated with R-CHOP: an international collaboration of the US intergoup, German high-grade non-hodgkin lymphoma study group and groupe d'etude de lymphome d'adultes

RH Advani;F Hong;TM Habermann;H Li;B Kahl;VA Morrison;EA Weller;G Varma;RI Fisher;BA Peterson;BD Cheson;R Gascoyne;SJ Horning;S Bousetta;B Coiffier;M Ziepert;M Pfreundschuh Blood 122:3045; American Society of Hematology annual meeting (Dec 7-10, 2013, New Orlean, LA), poster;

The role of body mass index in survival outcome for lymphoma patients: an Eastern Cooperative Oncology Group Experience

F Hong;TM Habermann;LI Gordon;H Hochster;R Gascoyne;RI Fisher;N Bartlett;P Stiff;B Cheson;M Crump;S Horning;B Kahl Blood 122:3060; American Society of Hematology annual meeting (Dec 7-10, 2013), poster;

2012

Differences in outcomes in males and females with diffuse large B-cell lymphoma and follicular lymphoma treated with rituximab (ECOG E4494, CALGB 9793, SWOG E4494, E1496)

T Habermann;F Hong;V Morrison;S Dakhil;SO Jacobson;JK Weick;S Frankel;R Gascoyne;R Fisher;B Cheson;EA Weller;BS Kahl;SJ Horning;BA Peterson;HS Hochster Blood 120(21):abst. 3535; American Society of Hematology Annual Meeting, poster;

2011

Gene expression profiling using paraffin-embedded tissues and the nuclease protection assay in diffuse large B-cell lymphoma (DLBCL) treated with CHOP or R-CHOP: an ECOG and SWOG correlative study of E4494

JN Winter;F Hong;L Rimsza;M LeBlanc;D Variakojis;M Krajewska;T Haberman;AM Melnick;JK Wwick;JC Reed;RI Fisher;BS Kahl;RD Gascoyne International Conference on Malignant Lymphoma, poster presentation

Gene risk scores based on expression of 6 genes quantitated by nuclease protein assay in formalin fixed paraffin-embedded DLBCL specimens from CHOP and RCHOP treated patients predicts outcome: an ECOG and SWOG study

JN Winter;F Hong;M LeBlanc;D Variakojis;M Krajewska;TM Habermann;AM Melnick;JW Weick;F Pollock;I Botros;JC Reed;RI Fisher;BS Kahl;R Gascoyne Blood 118(21):abstract 87; American Society of Hematology Annual Meeting, oral presentation

2010

Expression of p21 protein predicts clinical outcome in DLBCL patients treated with R-CHOP: a prospective ECOG and SWOG correlative study of E4494 [PMC2865202; PMID20371683]

JN Winter;V Aurora;V Variakojis;B Nelson;M Krajewska;L Zhang;T Habermann;RI Fisher;WR Macon;M Chhanabhai;RE Felgar;ED Hsi;LJ Medeiros;JK Weick;EA Weller;A Melnick;JC Reed;SJ Horning;RD Gascoyne Clinical Cancer Research 16(8):2435-2442;

Comparison of conventional prognostic indices in patients older than 60 years with diffuse large B-cell lymphoma treated with R-CHOP in the US Intergroup Study (ECOG 4494, CALGB 9793): consideration of age greater than 70 years in an elderly prognostic index (E-IPI)

R Advani;H Chen;V Morrison;E Weller;RI Fisher;B Peterson;R Gascoyne;S Horning British Journal of Haematology 151(2):143-151

PMid: PMID20735398 | PMC number: PMC3615251

R-CHOP versus (vs) CHOP followed by maintenance rituximab (MR) vs observation in older diffuse large B-cell lymphoma (DLBCL) patients (pts): long-term follow-up of Intergroup E4494/C9793

V Morrison;F Hong;T Haberman;RI Fisher;B Cheson;B Kahl;SJ Horning;B Peterson Blood 116:Abstract 589; ASH 2010 Annual Meeting; oral

2006

Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma

TM Habermann;EA Weller;VA Morrison;RD Gascoyne;PA Cassileth;JB Cohn;SR Dakhil;B Woda;RI Fisher;BA Peterson;SJ Horning Journal of Clinical Oncology 24(19):3121-3127

Prognostic significance of Bcl-6 protein expression in DLBCL treated with CHOP or R-CHOP: a prospective correlative study

JN Winter;EA Weller;SJ Horning;M Krajewska;D Variakojis;TM Habermann;RI Fisher;PJ Kurtin;WR Macon;M Chhanabhai;RE Felgar;ED Hsi;LJ Medeiros;JK Weick;JC Reed;RD Gascoyne Blood 107(11):4207-4213

2004

Rituximab-CHOP versus CHOP with or without maintenance rituximab in patients 60 years of age or older with diffuse large B-cell lymphoma (DLBCL): an update

TM Habermann;E Weller;VA Morrison;PA Cassileth;J Cohn;S Dakhil;RD Gascoyne;B Woda;R Fisher;BA Peterson;SJ Horning Blood 104(11): #127

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