RecruitingPhase IIEN originalLeukemia

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Potwierdzzona diagnoza ostrej białaczki szpikowej (AML)
  • •Wiek 18 lat lub więcej
  • •Pacjent nie kwalifikuje się do intensywnej chemioterapii lub ją odrzuca
  • •Dobry ogólny stan zdrowia (WHO 0, 1 lub 2)
  • •Prawidłowe funkcje nerek i wątroby
  • •Liczba białych krwinek poniżej 30 x10⁹/L
  • •Mężczyźni: gotowość stosowania antykoncepcji przez co najmniej 90 dni po leczeniu
  • •Kobiety: menopauza lub stosowanie antykoncepcji przez co najmniej 180 dni po leczeniu

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 23, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (19)

NL-Den Bosch-JBZ

's-Hertogenbosch, Netherlands

NL-Amersfoort-MEANDERMC

Amersfoort, Netherlands

NL-Amsterdam-AUMC

Amsterdam, Netherlands

NL-Amsterdam-OLVG

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-Nijmegen-RADBOUDUMC

Nijmegen, Netherlands

NL-Den Haag-HAGA

The Hague, Netherlands

NL-Zwolle-ISALA

Zwolle, Netherlands

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/24/2026.

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