S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.
Timeline
- Start
- 2001-03
- Primary completion
- 2011-09
- Completion
- 2025-12
Outcome
Missed primary endpoint
registry CHOP + Rituximab vs CHOP + Tositumomab; p = 0.11; Hazard Ratio (HR) 0.79 (95% CI 0.6 to 1.05) NCT00006721 ↗
registry CHOP + Rituximab vs CHOP + Tositumomab; p = 0.08; Hazard Ratio (HR) 1.55 (95% CI 0.95 to 2.54) NCT00006721 ↗
Publications
- Shadman M, LeBlanc M, Rimsza L, Leonard JP, Smith SM, Li H, Friedberg JW. Treatment of Follicular Lymphoma With CHOP and Anti-CD20 Therapy: 15-Year Follow-Up of the SWOG S0016 Trial. JAMA Oncol. 2026 Apr 1;12(4):394-401. doi: 10.1001/jamaoncol.2026.0042.
- Filip D, Litzmanova K, Michaelou A, Kledus F, Devan J, Boudny M, Hoferkova E, Sharma S, Seda V, Zeni PF, Borsky M, Matulova K, Kren L, Oppelt J, Blavet N, Hejret V, Urik M, Mareckova A, Rimsza LM, Kamaradova K, Belada D, Sykorova A, Mocikova H, Trneny M, Prouzova Z, Evans AG, Danilov A, Horn H, Ott G, Staber P, Mayer J, Friedberg JW, Janikova A, Mraz M. Repression of miR-29 via MYC leads to increased CD40 signaling in transformed follicular lymphoma. Leukemia. 2026 Apr;40(4):759-772. doi: 10.1038/s41375-026-02868-8. Epub 2026 Feb 19.
- Rutherford SC, Yin J, Pederson L, Perez Burbano G, LaPlant B, Shadman M, Li H, LeBlanc ML, Kenkre VP, Hong F, Blum KA, Dockter T, Martin P, Jung SH, Grant B, Rosenbaum C, Ujjani C, Barr PM, Unger JM, Cheson BD, Bartlett NL, Kahl B, Friedberg JW, Mandrekar SJ, Leonard JP. Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials. J Clin Oncol. 2023 Jan 10;41(2):336-342. doi: 10.1200/JCO.21.02301. Epub 2022 Jul 5.
- Shadman M, Li H, Rimsza L, Leonard JP, Kaminski MS, Braziel RM, Spier CM, Gopal AK, Maloney DG, Cheson BD, Dakhil S, LeBlanc M, Smith SM, Fisher RI, Friedberg JW, Press OW. Continued Excellent Outcomes in Previously Untreated Patients With Follicular Lymphoma After Treatment With CHOP Plus Rituximab or CHOP Plus 131I-Tositumomab: Long-Term Follow-Up of Phase III Randomized Study SWOG-S0016. J Clin Oncol. 2018 Mar 1;36(7):697-703. doi: 10.1200/JCO.2017.74.5083. Epub 2018 Jan 22.
- Press OW, Unger JM, Rimsza LM, Friedberg JW, LeBlanc M, Czuczman MS, Kaminski M, Braziel RM, Spier C, Gopal AK, Maloney DG, Cheson BD, Dakhil SR, Miller TP, Fisher RI. Phase III randomized intergroup trial of CHOP plus rituximab compared with CHOP chemotherapy plus (131)iodine-tositumomab for previously untreated follicular non-Hodgkin lymphoma: SWOG S0016. J Clin Oncol. 2013 Jan 20;31(3):314-20. doi: 10.1200/JCO.2012.42.4101. Epub 2012 Dec 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Vincristine | Small molecule | — | Intravenous |