NCT06030089

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

August 18, 2023

Last Update Submit

December 8, 2025

Conditions

Acute Myeloid Leukemia

Keywords

acute myeloid leukemiavenetoclaxazacitidine

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Overall survival

    1 year

Study Arms (1)

AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax

EXPERIMENTAL

Newly diagnosed AML patients

Other: Pharmacokinetic samplingOther: Vital status determinationOther: Toxicity assessmentsDrug: Venetoclax and azacitidine combination

Interventions

Vital status determinationOTHER

Survival situation 12 months after start of treament

AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
Toxicity assessmentsOTHER

Toxicity events

AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
Venetoclax and azacitidine combinationDRUG

Response to treatment

AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
Pharmacokinetic samplingOTHER

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

AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients receiving treatment inhibiting or inducing Cytochrome CYP3A4
  • Presence of an active, uncontrolled infection
  • Vulnerable persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital la Conception

Marseille, France

Location

CHU de Nice

Nice, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

venetoclax

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Thomas Cluzeau

    CHU of Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

September 8, 2023

Study Start

February 26, 2024

Primary Completion

September 30, 2024

Study Completion

March 3, 2025

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)