Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute Myeloblastic Leukemia

Официальное название

Prospective, Multicenter, Clinical-biological Cohort Study to Assess Pharmacokinetics and Pharmacodynamics (PK-PD) of Venetoclax (VEN) in Patients With Acute Myeloid Leukemia (AML)

Обзор

This is a prospective, multicenter, clinical-biological cohort study. Its objective is to assess the pharmacokinetics-pharmacodynamics (PK-PD) of venetoclax (VEN) in patients with Acute Myeloid Leukemia (AML). This study involves only minimal risks and constraints related to the collection of biological samples (blood samples for PK testing) and the collection of clinical data. Therapeutic management of patients participating in this study is not changed. A total of 100 patients will be included in the study over a 12-month period. A maximum of 21 additional samples are planned, with a maximum of 12 mL of blood per sampling day (4 mL at each sampling time) for PK dosing of venetoclax.

Вмешательства

• Другое Pharmacokinetic dosages of venetoclax
  Blood samples for pharmacokinetic dosing of venetoclax at different endpoints of treatment period

Первичные конечные точки

• Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint [Срок оценки: From the first day of venetoclax administration to end of the treatment (days)]
• Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint [Срок оценки: From the first day of venetoclax administration to end of the treatment (days)]
• Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint [Срок оценки: From the first day of venetoclax administration to end of the treatment (days)]
• Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Biological endpoint [Срок оценки: From the first day of venetoclax administration to end of the treatment (days)]
• Best pharmacokinetic (PK) indicator of response to treatment in patients with AML - Clinical Endpoint [Срок оценки: From the first day of venetoclax administration up to day 28 (end of the first venetoclax cure)]

Вторичные конечные точки (3)

• To assess relationship between different PK markers of venetoclax and its clinical efficacy. [Срок оценки: From the first day of venetoclax administration and through study completion, at least 24 months]
• To assess correlation between plasmatic exposition to venetoclax and occurrence of adverse events [Срок оценки: From the the first day of venetoclax administration to the last day (Day 168) of venetoclax administration]
• To assess inter-individual and intra-individual variability in plasma exposure to venetoclax. [Срок оценки: From the first day of ventoclax administration and nd through study completion, at least 24 months]

Критерии участия

Критерии включения

• Male or female patient aged of at least 18 years on day of signing informed consent
• Patient with histologically-confirmed diagnosis of Acute Myeloblactic Leukaemia according to classification ELN 2022 (European Leukemia Net 2022)
• Patient who has to initiate treatment venetoclax-azacitidine as first line. Note : triple associations with targeted therapy are not authorized
• Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed.
• Patient must be affiliated or benificiary of a social security system.

Критерии исключения

• Patient with acute promyelocytic leukemia (APL, AML3)
• Patient with AML eligible to intensive chemotherapy
• Patient previously treaed with venetoclax and/or azacitidine
• Patient participating to another clinical trial with a medicinal product
• Any condition that contraindicates blood sampling procedures required by the protocol
• Any psychological, family, geographical, or social situation that, according to investigator's judgment, could potentially prevent the signing of an informed consent form and/or woulld likely interfere compliance with study procedures.
• Patient under curatorship, guardianship or judicial protection
• Pregnant or breast-feeding female patient.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 5 центров

• Centre Hospitalier Pierre Oudot — Bourgoin
• CHU de Grenoble — Grenoble
• Centre Leon Berard — Lyon
• CHU de Saint-Étienne — Saint-Etienne
• Hôpitaux Nord-Ouest - Villefranche-sur-Saône — Villefranche-sur-Saône

Идентификаторы

NCT: NCT07243483 · ET24-223

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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