NCT06014489

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AML, Adult

Interventions

Type	Name	Description
DRUG	azacitidine	during run-in and extention phase: from Cycle 1 until relapse
DRUG	Venetoclax	during run-in and extention phase: from Cycle 1 until relapse
DRUG	Cobicistat	during run-in phase: from cycle 2 until relapse during extension phase: from cycle 1 until relapse

Timeline

• Start date: 2024-01-17
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2023-08-28
• Last updated: 2024-01-18

Locations

18 sites across 1 country: Netherlands