drugset / Trial / NCT02686346
Brentuximab Vedotin in Refractory/Relapsed Hodgkin Lymphoma Treated by ICE
Phase 1/2
Completed
53 enrolled
The Lymphoma Academic Research Organisation
Millennium Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen. The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma.
Timeline
- Start
- 2016-03
- Primary completion
- 2018-10-31
- Completion
- 2021-07-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brentuximab Vedotin | Monoclonal antibody | 0.8 mg/kg | — |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.2 mg/kg | — |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.8 mg/kg | — |
| Background | Carboplatin | Small molecule | 800 mg | — |
| Background | Etoposide | Small molecule | 100 mg/m2 | — |
| Background | Ifosfamide | Small molecule | 5 g | — |