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Идёт набор NCT06557421

De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients

Фаза II С лечением Acute Myeloid Leukemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Venetoclax, Azacitidine.
Кому может быть актуально
Состояния в реестре: Acute Myeloid Leukemia. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are: * Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival. * Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy. Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria. Participants will: * Stop VEN-DASA treatment * Be closely monitored by regular evaluation of the disease

Вмешательства

  • Препарат Venetoclax
    complete discontinuation of Venetoclax
  • Препарат Azacitidine
    complete discontinuation of Azacitidine

Первичные конечные точки

  • Disease-Free Survival, measured from inclusion (VEN-AZA de-escalation) to the date of morphologic or measurable residual disease relapse or death from any cause, whichever occurs first. [Срок оценки: 24 months]
Вторичные конечные точки (12)
  • Absolute duration of hematologic response, defined as the time from inclusion to relapse or death. [Срок оценки: 24 months]
  • Absolute duration of negative measurable residual disease response, defined as the time from inclusion to measurable residual disease relapse or death. [Срок оценки: 24 months]
  • Cumulative incidence of relapse, defined as the probability of relapse over time. [Срок оценки: 24 months]
  • Overall survival, defined as the time from inclusion (VEN-AZA de-escalation) to death. [Срок оценки: 24 months]
  • Second complete remission occurence. [Срок оценки: 24 months]
  • Time to second remission, defined as the time between date of treatment re initiation and complete remission. [Срок оценки: 24 months]
  • Hospitalization rate associated with VEN-AZA de-escalation. [Срок оценки: 24 months]
  • Transfusion occurrence associated with VEN-AZA de-escalation. [Срок оценки: 24 months]
  • Grade 3-4 adverse events occurence associated with VEN-AZA de-escalation. [Срок оценки: 24 months]
  • Correlation between age and duration of response and survival after VEN-AZA de-escalation. [Срок оценки: 24 months]
  • Correlation between FAB classification and duration of response and survival after VEN-AZA de-escalation. [Срок оценки: 24 months]
  • Correlation between cytogenetic and molecular alterations and duration of response and survival after VEN-AZA de-escalation. [Срок оценки: 24 months]

Критерии участия

Критерии включения

  • Female/Male ≥ 18 years of age;
  • Diagnosis of previously untreated AML according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemias;
  • VEN-AZA given as first-line treatment;
  • Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses;
  • Patients in first composite complete remission (CRc) defined as complete remission (CR) or CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh);
  • Absence of detectable minimal residual disease (MRD) performed locally (i.e. MRDneg defined as MCF MRD <0.1% of CD45 expressing cells with the target immunophenotype in bone marrow, or NPM1 or RUNX1-RUNX1T1 or CBFB-MYH11 MRD copy numbers <0.1% in the blood);
  • ECOG <3;
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
  • Affiliated to the French Social Security or beneficiary of such a health Insurance;
  • Signed informed consent.

Non inclusion Criteria:

  • VEN-AZA given as salvage therapy;
  • Prior allogeneic stem cell transplant;
  • Discontinuation of treatment because of absence or loss of response;
  • Patient in emergency situation or unable to give consent;
  • Severe medical or mental condition precluding the follow up procedures after treatment discontinuation.

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
Лечение

Центры проведения

Франция · 1 центр
  • Institut Paoli-Calmettes — Marseille

Идентификаторы

NCT: NCT06557421 · STOP VEN-IPC 2024-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗