Phase 1/2Recruiting
Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL (AETHER)
A Prospective Randomized Phase I/II Trial of Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (Academic or other)
- Enrolment
- 112 planned
- Conditions
- CLL/SLL
- Interventions
- Epcoritamab; Venetoclax
- Ages
- adults, older adults
- Registry
- NCT05791409
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- • Recommended phase II dose (RP2D) for the combination of venetoclax and epcoritamab based on dose limiting toxicity (DLT)
- • Undetectable minimal residual disease <10-4 (uMRD) in BM in absence of progression according to IWCLL criteria at 12 weeks after cycle 26
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered