A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML
A Single Arm Phase II Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine (sc) in Adult Patients With Newly Diagnosed Acute Myeloid Leukaemia (AML) Who Are Not Considered Candidates for Intensive Treatment Regimens
Stichting Hemato-Oncologie voor Volwassenen Nederland
142 participants
Jan 17, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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Interventions
during run-in and extention phase: from Cycle 1 until relapse
during run-in and extention phase: from Cycle 1 until relapse
during run-in phase: from cycle 2 until relapse during extension phase: from cycle 1 until relapse
Locations(18)
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NCT06014489