drugset / Trial / NCT02292979
Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Hodgkin Lymphoma.
Phase 2
Completed
170 enrolled
The Lymphoma Academic Research Organisation
Millennium Pharmaceuticals, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy.
Timeline
- Start
- 2015-03
- Primary completion
- 2016-12
- Completion
- 2022-06-02
Publications
- Goldkuhle M, Kreuzberger N, von Tresckow B, Eichenauer DA, Specht L, Monsef I, Skoetz N. Chemotherapy alone versus chemotherapy plus radiotherapy for adults with early-stage Hodgkin's lymphoma. Cochrane Database Syst Rev. 2024 Dec 2;12(12):CD007110. doi: 10.1002/14651858.CD007110.pub4.
- Fornecker LM, Lazarovici J, Aurer I, Casasnovas RO, Gac AC, Bonnet C, Bouabdallah K, Feugier P, Specht L, Molina L, Touati M, Borel C, Stamatoullas A, Nicolas-Virelizier E, Pascal L, Lugtenburg P, Di Renzo N, Vander Borght T, Traverse-Glehen A, Dartigues P, Hutchings M, Versari A, Meignan M, Federico M, Andre M; LYSA-FIL-EORTC Intergroup. Brentuximab Vedotin Plus AVD for First-Line Treatment of Early-Stage Unfavorable Hodgkin Lymphoma (BREACH): A Multicenter, Open-Label, Randomized, Phase II Trial. J Clin Oncol. 2023 Jan 10;41(2):327-335. doi: 10.1200/JCO.21.01281. Epub 2022 Jul 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bleomycin | Unknown | 10 mg/m2 | — |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.2 mg/kg | — |
| Background | Dacarbazine | Small molecule | 375 mg/m2 | — |
| Background | Doxorubicin | Other / unclassified | 25 mg/m2 | — |
| Background | Vinblastine | Small molecule | 6 mg/m2 | — |