Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven
NCT ID: NCT06030089
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2024-02-26
2025-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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AML patients ineligible for intensive chemotherapy and treated with azacitidine and venetoclax
Newly diagnosed AML patients
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
Venetoclax and azacitidine combination
Response to treatment
Interventions
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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
Venetoclax and azacitidine combination
Response to treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of an active, uncontrolled infection
* Patient participating or having participated in a clinical drug trial in the month prior to inclusion.
* Vulnerable persons
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Thomas Cluzeau
Role: PRINCIPAL_INVESTIGATOR
CHU of Nice
Locations
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Hopital la Conception
Marseille, , France
CHU de Nice
Nice, , France
Countries
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Other Identifiers
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23-AOIP-01
Identifier Type: -
Identifier Source: org_study_id