ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Summary
This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.
Timeline
- Start
- 2013-01-31
- Primary completion
- 2018-08-15
- Completion
- 2020-10-02
Outcome
Met primary endpoint
paper Median progression-free survival was 48·2 months (95% CI 35·2-not evaluable) in the A+CHP group and 20·8 months (12·7-47·6) in the CHOP group PMID 30522922 ↗
paper hazard ratio 0·71 [95% CI 0·54-0·93], p=0·0110). PMID 30522922 ↗
paper Front-line treatment with A+CHP is superior to CHOP for patients with CD30-positive peripheral T-cell lymphomas PMID 30522922 ↗
release “the phase 3 ECHELON-2 clinical trial met its primary endpoint.” takeda.com ↗
release “The ECHELON-2 study met its primary endpoint with ADCETRIS plus CHP demonstrating a statistically significant improvement in PFS” takeda.com ↗
release “the ECHELON-2 trial met its primary endpoint” takeda.com ↗
release “ECHELON-2 Trial, Which Demonstrated Treatment with ADCETRIS Plus CHP (cyclophosphamide, doxorubicin, prednisone) Resulted in Significant Improvement in Progression-Free Survival” takeda.com ↗
release “The study met its primary endpoint with ADCETRIS plus CHP demonstrating a statistically significant improvement in progression-free survival (PFS) in the intent to treat population” takeda.com ↗
Publications
- Iyer S, Mehta-Shah N, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Alpdogan O, Feldman TA, Camus V, Gritti G, Zinzani PL, Belada D, Mayer J, Choi I, Cheong JW, Rustia E, Fenton K, Fanale M, Savage KJ, Horwitz SM. Association of PET4 response with outcomes of BV-CHP vs CHOP in the ECHELON-2 trial in CD30+ peripheral T-cell lymphoma. Blood Adv. 2025 Dec 9;9(23):5976-5987. doi: 10.1182/bloodadvances.2024015282.
- Domingo-Domenech E, Pro B, Illidge T, Horwitz S, Trumper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Kim WS, Feldman T, Choi I, Gritti G, Belada D, Shustov A, Illes A, Zinzani PL, Huttmann A, Trneny M, Le Gouill S, Jagadeesh D, Friedberg JW, Little M, Dong C, Fanale M, Fenton K, Savage KJ. Brentuximab vedotin plus chemotherapy for the treatment of front-line systemic anaplastic large cell lymphoma: subgroup analysis of the ECHELON-2 study at 5 years' follow-up. Blood Cancer J. 2025 Aug 1;15(1):129. doi: 10.1038/s41408-025-01329-2.
- Savage KJ, Horwitz SM, Advani R, Christensen JH, Domingo-Domenech E, Rossi G, Morschhauser F, Alpdogan O, Suh C, Tobinai K, Shustov A, Trneny M, Yuen S, Zinzani PL, Trumper L, Ilidge T, O'Connor OA, Pro B, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Iyer S. Role of stem cell transplant in CD30+ PTCL following frontline brentuximab vedotin plus CHP or CHOP in ECHELON-2. Blood Adv. 2022 Oct 11;6(19):5550-5555. doi: 10.1182/bloodadvances.2020003971.
- Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illes A, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Huttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trumper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. doi: 10.1016/S0140-6736(18)32984-2. Epub 2018 Dec 4.
- Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.8 mg/kg | Intravenous |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 100 mg | Oral |