Venetoclax Treatment (26 Cycles) With 6 Cycles or 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory CLL or SLL

Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study ID
NCT05791409
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • CLL/SLL

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epcoritamab — DRUG
    Number of cycles of epcoritamab is either 6 (cycle 1-6) or 12 (cycle 1-12). Patients will be treated until they have received the total number of assigned treatment cycles or until progression, or severe toxicity, whichever comes first.
  • Venetoclax — DRUG
    All patients will receive venetoclax cycle 1-26 (a 5 week ramp-up of venetoclax will precede the first cycle). Patients will be treated until they have received the total number of assigned treatment cycles or until progression, or severe toxicity, whichever comes first.

Study Details

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.

Key Dates

Start date
Apr 10, 2024
Status verified
Apr 2024
Primary completion
Mar 31, 2029
Completion
Nov 30, 2032

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    6 cycles epcoritamab + 26 cycles venetoclax
  • Experimental: Arm B
    12 cycles epcoritamab + 26 cycles venetoclax

Primary Outcome Measure

• Recommended phase II dose (RP2D) for the combination of venetoclax and epcoritamab based on dose limiting toxicity (DLT) [ Time Frame: 6-12 months ]

Central Contacts

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