Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL
Summary
Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone. Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL.
Timeline
- Start
- 2020-08-20
- Primary completion
- 2026-01-12
- Completion
- 2026-12-31
Outcome
Met primary endpoint
paper The median OS was 13.8 months with BV + Len + R versus 8.5 months with placebo + Len + R PMID 39772655 ↗
paper hazard ratio, 0.63 [95% CI, 0.45 to 0.89]; two-sided P = .009 PMID 39772655 ↗
paper BV + Len + R demonstrated a statistically significant survival benefit PMID 39772655 ↗
release “ECHELON-3 trial of ADCETRIS in combination with lenalidomide and rituximab showed significant improvement in primary endpoint of overall survival” pfizer.com ↗
release “Detailed data from Phase 3 ECHELON-3 study demonstrate investigational ADCETRIS regimen reduced risk of death by 37 percent compared to chemotherapy alone” pfizer.com ↗
release “The ECHELON-3 study showed that the ADCETRIS combination reduced patients’ risk of death by 37% compared to placebo in combination with lenalidomide and rituximab” pfizer.com ↗
release “Phase 3 ECHELON-3 study, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS)” pfizer.com ↗
Publications
- Bartlett NL, Hahn U, Kim WS, Fleury I, Laribi K, Bergua JM, Bouabdallah K, Forward N, Bijou F, MacDonald D, Portell CA, Ghesquieres H, Nowakowski G, Yasenchak CA, Patterson M, Ho L, Rustia E, Fanale M, Jie F, Kim JA. Brentuximab Vedotin Combination for Relapsed Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2025 Mar 20;43(9):1061-1072. doi: 10.1200/JCO-24-02242. Epub 2025 Jan 7.
- Ward JP, Berrien-Elliott MM, Gomez F, Luo J, Becker-Hapak M, Cashen AF, Wagner-Johnston ND, Maddocks K, Mosior M, Foster M, Krysiak K, Schmidt A, Skidmore ZL, Desai S, Watkins MP, Fischer A, Griffith M, Griffith OL, Fehniger TA, Bartlett NL. Phase 1/dose expansion trial of brentuximab vedotin and lenalidomide in relapsed or refractory diffuse large B-cell lymphoma. Blood. 2022 Mar 31;139(13):1999-2010. doi: 10.1182/blood.2021011894.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.2 mg/kg | Intravenous |
| Background | Lenalidomide | Other / unclassified | 20 mg | Oral |
| Background | Rituximab | Monoclonal antibody | 1400 mg | Intravenous |