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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06030089

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Other: Pharmacokinetic sampling Other: Vital status determination Other: Toxicity assessments Drug: Venetoclax and azacitidine combination	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official 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

Anticipated Study Start Date :

Oct 15, 2023

Anticipated Primary Completion Date :

Oct 15, 2024

Anticipated Study Completion Date :

Oct 15, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Plasmatic dosage [Before treatment]
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Plasmatic dosage [At Day 5 of 1st round of chemotherapies]
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Plasmatic dosage [At Day 9 of 1st round of chemotherapies]
Correlation of VEN plasma levels with inhibition of its Bcl-2 target
Plasmatic dosage [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 Outcome Measures

Overall survival [1 year]
Evaluate the overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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