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

Study acronym: AETHER
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 2 entries Trial sites expanded: 24 → 29 locations · Completion date: Nov 2032 to Dec 2032 · Start date: Apr 10, 2024 to Apr 15, 2024 · 2 more Show 5 more changesShow less
    • Trial sites expanded: 24 → 29 locations
    • Completion date: Nov 2032 to Dec 2032
    • Start date: Apr 10, 2024 to Apr 15, 2024
    • Eligibility criteria expanded, about 48 words
    • Collaborators: 2 to 3
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 9, 2023 to Apr 10, 2024 · Primary endpoints revised (2) · Eligibility criteria shortened, about 44 words · 2 morev2 Show 5 more changesShow less
    • Start date changed from estimate of Nov 9, 2023 to Apr 10, 2024
    • Primary endpoints revised (2)
    • Eligibility criteria shortened, about 44 words
    • Secondary endpoints revised (14)
    • Study sites revised (24)

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05791409
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Collaborators: Nordic CLL Study Group (NCLLSG), The Australasian Leukaemia & Lymphoma Group (ALLG), German CLL Study Group (GCLLSG)
Conditions CLL/SLL
Enrollment 112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov