drugset / Trial / NCT03517137
Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study
Phase 2
Active not recruiting
150 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
NaSingle-groupOpen-labelTreatment
Summary
The main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET/CT results in improved efficacy while minimizing treatment toxicity in advanced stage Hodgkin Lymphoma (HL) patients treated with brentuximab vedotin (BV)-containing regimens.
Timeline
- Start
- 2019-08-01
- Primary completion
- 2023-08-28
- Completion
- 2026-11-16
Publications
- Hutchings M, Diepstra A, Sureda Balari A, Carvalho S, Vranovsky A, Noordzij W, Loft A, Arens A, Teesink S, Visser L, Stevens W, Aleman BMP, Woei-A-Jin FJSH, Viguria M, Saevels K, Te Boome L, Tonino S, Meijnders P, Domingo Domenech E, Hasselbalch Riley C, Musekera L, Nuyens S, Mallien C, Sents W, Buhrer E, Fortpied C, Plattel WJ. Very early [18F]FDG-PET-guided targeted therapy in untreated advanced-stage classic Hodgkin lymphoma (EORTC-1537-COBRA): primary results of a single-arm, multicentre, phase 2 trial. Lancet Haematol. 2026 May;13(5):e274-e283. doi: 10.1016/S2352-3026(26)00068-2.
- Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.2 mg/kg | Intravenous |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.8 mg/kg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 1250 mg/m2 | Intravenous |
| Subject | Dacarbazine | Small molecule | 250 mg/m2 | Intravenous |
| Subject | Dacarbazine | Small molecule | 375 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 40 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Vinblastine | Small molecule | 6 mg/m2 | Intravenous |