Clinical Trial

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

Study acronym: HO171
Recruiting Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-08-23.
Status change: Not Yet Recruiting → Recruiting 2024-01-17
Trial Details
NCT Number NCT06014489
Lead Sponsor Stichting Hemato-Oncologie voor Volwassenen Nederland
Conditions AML, Adult
Enrollment 142 participants
Start Date 2024-01-17
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2024-01-18