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

Acute Myeloid Leukemia Clinical Trial

— VENETACIBLE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030089
• Other study ID #: 23-AOIP-01
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: October 15, 2025

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Thomas Cluzeau, Pr
• Phone: 0492035841
• Email: cluzeau.t[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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
• Vital status determination
Survival situation 12 months after start of treament
• Toxicity assessments
Toxicity events

Drug:
• Venetoclax and azacitidine combination
Response to treatment

Locations

Country	Name	City	State
France	Hopital la Conception	Marseille
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasmatic dosage	Correlation of VEN plasma levels with inhibition of its Bcl-2 target	Before treatment
Primary	Plasmatic dosage	Correlation of VEN plasma levels with inhibition of its Bcl-2 target	At Day 5 of 1st round of chemotherapies
Primary	Plasmatic dosage	Correlation of VEN plasma levels with inhibition of its Bcl-2 target	At Day 9 of 1st round of chemotherapies
Primary	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	Overall survival	Evaluate the overall survival	1 year