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Relation Between Venetoclax Plasma Concentration and Remission in Adults With Acute Myeloid Leukemia (PREDICLAX)

Adult Acute Myeloid Leukemia Clinical Trial

Official title:
Study of the Association Between Residual Venetoclax Plasma Concentration and Composite Complete Remission in Adults With Newly Diagnosed Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy (PREDICLAX)

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06045819
Study type Observational
Source University Hospital, Caen
Contact Sylvain Chantepie, MD
Phone +33231272107
Email chantepie-s@chu-caen.fr
Status Not yet recruiting
Phase
Start date January 2024
Completion date January 2026
View Details
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