drugset / Trial / NCT05791409
Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL
Phase 1/2
Recruiting
112 enrolled
HOVON Foundation
German CLL Study Group (GCLLSG) · collabNordic CLL Study Group (NCLLSG) · collabThe Australasian Leukaemia & Lymphoma Group (ALLG) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
In this study, efficacy and safety of 2 regimens that combine the CD3-CD20 T cell engager epcoritamab with venetoclax will be tested in relapsed/refractory CLL and SLL patients. The trial starts with phase I part to establish the recommended dose level (RDL) of epcoritamab in the combination with venetoclax for the phase II trial.
Timeline
- Start
- 2024-04-15
- Primary completion
- 2029-03
- Completion
- 2032-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epcoritamab | Monoclonal antibody | — | — |
| Subject | Venetoclax | Small molecule | — | — |