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REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Interventions: Venetoclax/Acalabrutinib (Drug) to Venetoclax/Acalabrutinib (Drug) Eligibility criteria expanded, about 42 words · Study description revised Show 2 more changesShow less
    • Eligibility criteria expanded, about 42 words
    • Study description revised
  2. Minor Site details revised at 5 of 18 sitesv9
  3. Minor 2 versions Re-verified since Mar 22, 2022, no change to tracked fieldsv7-v8
  4. Minor Study sites: 1 to 18v6
  5. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2020 to Dec 23, 2020 · Site details revisedv5 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2020 to Dec 23, 2020
    • Site details revised
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: Oct 2020 to Dec 2020 Primary completion date: Oct 2028 to Dec 2028 · Completion date: Oct 2032 to Dec 2032v4 Show 2 more changesShow less
    • Primary completion date: Oct 2028 to Dec 2028
    • Completion date: Oct 2032 to Dec 2032
  2. Minor Study sites: 0 to 1v3
  3. Notable Primary endpoint revised Interventions: Acalabrutinib (Drug) to Venetoclax/Acalabrutinib (Drug) · Study description expanded, about 147 words · Study arms: 0 to 1v2 Show 3 more changesShow less
    • Interventions: Acalabrutinib (Drug) to Venetoclax/Acalabrutinib (Drug)
    • Study description expanded, about 147 words
    • Study arms: 0 to 1

    See this version in full on ClinicalTrials.gov ↗

  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Fixed-duration regimens containing combinations of venetoclax with CD20 targeting agents are expected to soon become standard practice in first-line patients with chronic lymfocytic leukemia (CLL). The advantage of a fixed duration venetoclax combination as part of first-line treatment is the potential to retreat with venetoclax in patients who develop relapsed disease after a treatment free period. However, efficacy of venetoclax retreatment following a fixed duration venetoclax combination is still hypothetical as clinical data are lacking. Thus, there is an urgent need for data proving efficacy of venetoclax combinations following venetoclax treatment cessation. Testing of a novel venetoclax-containing regimen for relapsed CLL without the repeat of anti-CD20 monoclonal antibody (mAb) is a rational approach.
Trial Details
NCT Number NCT04523428
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Conditions CLL/SLL
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov