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

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 allowin

Trial Details

NCT ID
NCT06014489
Phase
PHASE2
Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • azacitidine
  • Venetoclax
  • Cobicistat
Locations (sample)
  • Amersfoort, Netherlands|52.155,5.3875
  • Amsterdam, Netherlands|52.37403,4.88969
  • Amsterdam, Netherlands|52.37403,4.88969
  • Arnhem, Netherlands|51.98,5.91111
  • Breda, Netherlands|51.58656,4.77596

Key Eligibility Criteria

  • In order to be eligible to participate in this study, a patient must meet all of the following criteria:
  • Patients with: a diagnosis of AML and related precursor neoplasms according to ICC-2022 classification (excluding acute promyelocytic leukaemia) (a…
  • Patients 18 years and older who are considered not fit for intensive chemotherapy or who decline the option of intensive chemotherapy.
  • WHO performance status 0, 1 or 2 (appendix E).

For full eligibility, visit ClinicalTrials.gov.

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