Actively Recruiting
Relation Between Venetoclax Plasma Concentration and Remission in Adults with Acute Myeloid Leukemia (PREDICLAX)
Led by University Hospital, Caen · Updated on 2025-02-28
100
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: In combination with hypomethylating drugs, venetoclax has recently changed the therapeutic management of patients with newly diagnosed acute myeloid leukemia (AML) for whom standard induction chemotherapy was not an option. Over and above the clinical benefits of this combination, the data show that more than half the patients did not show remission criteria, even after the first month's exposure to venetoclax. Hypothesis: To compare the mean residual venetoclax plasma concentrations obtained in patients who went into complete composite remission versus those who did not go into remission at the end of the first cycle of venetoclax + azacitidine treatment. Method: According to the French law, this is a multicenter, non-comparative, open-label, single-arm, interventional study with minimal risks and constraints. Selection, information and inclusion will concern adult patients (≥60 years) with a confirmed diagnosis of AML according to ELN 2022 guidelines. Included patients will be treated as standard care with a combination of venetoclax+azacitidine. This research protocol will not modify their usual care.
CONDITIONS
Official Title
Relation Between Venetoclax Plasma Concentration and Remission in Adults with Acute Myeloid Leukemia (PREDICLAX)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of previously untreated AML according to ELN 2022 criteria within 28 days of symptom onset
- Ineligible for standard induction chemotherapy due to age 75 or older, or age 60-74 with specified comorbidities
- Eligible for standard treatment with venetoclax and a hypomethylating agent
- Voluntary signing and dating of informed consent form
- Participation in another interventional study allowed if it does not interfere with this study's rationale
You will not qualify if you...
- Blood leukocytes greater than 25 G/L
- Prior anticancer treatment for AML, hematological malignancy, or cancer within past 2 years
- AML with central nervous system involvement or promyelocytic type (AML-M3)
- Uncontrolled intercurrent diseases including infections requiring treatment, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, psychiatric illness or drug addiction limiting compliance
- Documented hypersensitivity to study drugs
- Exposure to potent CYP450 inducers or inhibitors within 7 days before treatment start
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Caen
Caen, France, 14000
Actively Recruiting
Research Team
S
Sylvain Chantepie, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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