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

NCT06045819 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-02-28

No results posted yet for this study

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.

Conditions

  • Adult Acute Myeloid Leukemia

Interventions

BIOLOGICAL

Blood sampling for venetoclax drug dosage (venous puncture)

8 blood samples for venetoclax and azole antifungal drugs identification and dosage will be taken by venous and capillary punctures throughout management of patients

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Pierre-Marie Morice, PharmD, PhD · University Teaching Hospital of Caen

  • Sylvain Chantepie, MD · University Teaching Hospital of Caen

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2025-02-28
Completion
2026-01-31
FDA Drug
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06045819 on ClinicalTrials.gov