Skip to main content
OpenTrials
Completed

NCT Number: NCT06030089

Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven

The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital la Conception, Marseille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with acute myeloid leukemia (AML) not eligible for intensive chemotherapy
  • Patients aged 18 or over
  • Patient treated with the combination azacitidine (AZA) + venetoclax (VEN)
  • Patient having signed the study informed consent form
  • Patient with social security coverage

Exclusion criteria

  • Patients receiving treatment inhibiting or inducing Cytochrome CYP3A4
  • Presence of an active, uncontrolled infection
  • Patient participating or having participated in a clinical drug trial in the month prior to inclusion.
  • Vulnerable persons

Treatment and study plan

Pharmacokinetic sampling

Other

4 blood withdrawals ( before treatment, Day 5, Day 9 and relapse or 12 months after start of treatment) for the plasma dosage of VEN and inhibition of its Bcl-2

Vital status determination

Other

Survival situation 12 months after start of treament

Toxicity Assessments

Other

Toxicity events

Venetoclax and azacitidine combination

Drug

Response to treatment

Primary outcomes

  1. Plasmatic dosage

    Time frame: Before treatment

    Correlation of VEN plasma levels with inhibition of its Bcl-2 target

  2. Plasmatic dosage

    Time frame: At Day 5 of 1st round of chemotherapies

    Correlation of VEN plasma levels with inhibition of its Bcl-2 target

  3. Plasmatic dosage

    Time frame: At Day 9 of 1st round of chemotherapies

    Correlation of VEN plasma levels with inhibition of its Bcl-2 target

  4. Plasmatic dosage

    Time frame: At 12 months after start of treatment or at relapse whichever comes first

    Correlation of VEN plasma levels with inhibition of its Bcl-2 target

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

    Evaluate the overall survival

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Plasma Dosage of Venetoclax in the Follow-up of Acute Myeloid Leukemias Ineligible for Intensive Chemotherapy in the First Line of Treatment and Treated With Azacitidine + Venetoclax. Pilot Study VENETACIBLE

Acronym: VENETACIBLE

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 8, 2023
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.