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A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML

Study acronym: HO171
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Mar 2028 → Dec 2028
See other at-risk trials from Stichting Hemato-Oncologie voor Volwassenen Nederland

Record History

  1. Primary and study completion pushed from Mar 2028 to Dec 2028 Study sites: 18 to 19 · Eligibility criteria expanded, about 41 words · Secondary endpoints: details revised at 3 of 20 entries · 1 more Show 4 more changesShow less
    • Study sites: 18 to 19
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: details revised at 3 of 20 entries
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Not Yet Recruiting to Recruiting Primary endpoints revised (2) · Start date changed from estimate of Dec 2023 to Jan 17, 2024 · Eligibility criteria expanded, about 10 words · 2 morev2 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Start date changed from estimate of Dec 2023 to Jan 17, 2024
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 18 to 20
    • Study sites revised (18)

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The treatment of older unfit patients with acute myeloid leukemia (AML) is challenging. The hypomethylating agents (HMA) azacitidine and decitabine have relatively mild side effects and have proven to be feasible for the treatment of older patients and patients with co-morbidities. Currently, venetoclax added to an HMA agent is the new standard of treatment. Since this new standard comes with a substantial societal financial burden, there is a rational to optimize the venetoclax dosing schedule. The CYP3A4 inhibitor cobicistat (COBI) can be used to increase venetoclax exposure, thereby allowing to reduce the dose of venetoclax and thus costs substantially.
Trial Details
NCT Number NCT06014489
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Conditions AML, Adult
Enrollment 142 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov