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

Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study ID
NCT06014489
Phase
PHASE2
Status
Recruiting
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Conditions

  • AML, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 17, 2024
Status verified
Jan 2024
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
142 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: single arm arm extension phase
    prior to the extention phase, there is a run-in phase with (n= 20 patients of 142 total) with the same study scheme, except that cobicistat is added from cycle 2 onwards to the treatment instead of during cycle 1

Primary Outcome Measure

Pharmacokinetic equivalence of cobicistat boosted venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2).venetoclax and unboosted venetoclax (PK cycle 1 vs PK cycle 2). [ Time Frame: 6-8 months ]

Central Contacts

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