RecruitingPhase 2NCT06014489

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


Sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Enrollment

142 participants

Start Date

Jan 17, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a boosted version of venetoclax (combined with cobicistat, which helps raise venetoclax blood levels) plus azacitidine for people newly diagnosed with acute myeloid leukemia (AML) who are either not fit for intensive chemotherapy or prefer to avoid it. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with AML (excluding a type called acute promyelocytic leukemia) - You are not suitable for or choose to decline intensive (standard) chemotherapy - You are in reasonably good health (WHO performance status 0–2) - Your kidney and liver function are within acceptable limits **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL/M3) - You are fit and willing to receive intensive chemotherapy - You are currently taking strong medications that interact with venetoclax or cobicistat - You are pregnant or breastfeeding, or not using contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGazacitidine

during run-in and extention phase: from Cycle 1 until relapse

DRUGVenetoclax

during run-in and extention phase: from Cycle 1 until relapse

DRUGCobicistat

during run-in phase: from cycle 2 until relapse during extension phase: from cycle 1 until relapse


Locations(18)

NL-Amersfoort-MEANDERMC

Amersfoort, Netherlands

NL-Amsterdam-OLVG

Amsterdam, Netherlands

NL-Amsterdam-VUMC

Amsterdam, Netherlands

NL-Arnhem-RIJNSTATE

Arnhem, Netherlands

NL-Breda-AMPHIA

Breda, Netherlands

NL-Dordrecht-ASZ

Dordrecht, Netherlands

NL-Eindhoven-CATHARINA

Eindhoven, Netherlands

NL-Eindhoven-MAXIMAMC

Eindhoven, Netherlands

NL-Enschede-MST

Enschede, Netherlands

NL-Groningen-UMCG

Groningen, Netherlands

NL-Leeuwarden-MCL

Leeuwarden, Netherlands

NL-Leiden-LUMC

Leiden, Netherlands

NL-Maastricht-MUMC

Maastricht, Netherlands

NL-Nieuwegein-ANTONIUS

Nieuwegein, Netherlands

NL-Nijmegen-CWZ

Nijmegen, Netherlands

NL-Rotterdam-ERASMUSMC

Rotterdam, Netherlands

NL-Den Haag-HAGA

The Hague, Netherlands

NL-Zwolle-ISALA

Zwolle, Netherlands

View Full Details on ClinicalTrials.gov

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NCT06014489


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