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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: Pharmacokinetic sampling; Other: Vital status determination; Other: Toxicity assessments; Drug: Venetoclax and azacitidine combination

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Hôpital la Conception
  • Nice, France
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax; Newly diagnosed AML patients	Other: Pharmacokinetic sampling; 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; Other: Vital status determination; Survival situation 12 months after start of treament; Other: Toxicity assessments; Toxicity events; Drug: Venetoclax and azacitidine combination; Response to treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasmatic dosage	Correlation of VEN plasma levels with inhibition of its Bcl-2 target	Before treatment
Plasmatic dosage	Correlation of VEN plasma levels with inhibition of its Bcl-2 target	At Day 5 of 1st round of chemotherapies
Plasmatic dosage	Correlation of VEN plasma levels with inhibition of its Bcl-2 target	At Day 9 of 1st round of chemotherapies
Plasmatic dosage	Correlation of VEN plasma levels with inhibition of its Bcl-2 target	At 12 months after start of treatment or at relapse whichever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Evaluate the overall survival	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Thomas Cluzeau, CHU of NICE

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): March 3, 2025

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: venetoclax; acute myeloid leukemia; azacitidine
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; venetoclax
• Other Study ID Numbers: 23-AOIP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No