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

Not Applicable

Active, not recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Other: Pharmacokinetic sampling; Other: Vital status determination; Other: Toxicity assessments; Drug: Venetoclax and azacitidine combination

• Registration Number: NCT06030089
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-08
• Study Start: 2024-02-26
• Primary Completion: 2024-09-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Study Completion: 2025-10-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax	Pharmacokinetic sampling	Newly diagnosed AML patients
AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax	Vital status determination	Newly diagnosed AML patients
AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax	Toxicity assessments	Newly diagnosed AML patients
AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax	Venetoclax and azacitidine combination	Newly diagnosed AML patients

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall survival	1 year	Evaluate the overall survival

Trial Locations

Locations (2)

Hopital la Conception; 🇫🇷 Marseille, France

CHU de Nice; 🇫🇷 Nice, France