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

NCT06014489 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2024-01-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Stichting Hemato-Oncologie voor Volwassenen Nederland

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06014489 on ClinicalTrials.gov