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

Sponsor
Centre Hospitalier Universitaire de Nice
Study ID
NCT06030089
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pharmacokinetic sampling — OTHER
    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 — OTHER
    Survival situation 12 months after start of treament
  • Toxicity assessments — OTHER
    Toxicity events
  • Venetoclax and azacitidine combination — DRUG
    Response to treatment

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
Dec 2025
Primary completion
Sep 30, 2024
Completion
Mar 3, 2025

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
    Newly diagnosed AML patients

Primary Outcome Measure

Plasmatic dosage [ Time Frame: Before treatment ]

Related Studies