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Идёт набор NCT06511882

Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD

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: Azacitidine, Decitabine, Venetoclax.
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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Discontinuation of Hypomethylating Agent and Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Who Have Achieved Negative Measurable Residual Disease (MRD)

Обзор

The purpose of this research study is to see if people whose Acute myeloid leukemia (AML) is being successfully treated with azacitidine or decitabine in combination with venetoclax can discontinue this chemotherapy for some period of time after a year of treatment without increasing the likelihood that their AML will return.

Вмешательства

  • Препарат Azacitidine
    Standard of Care Intravenous (IV) infusion
  • Препарат Decitabine
    Standard of Care Intravenous (IV) infusion
  • Препарат Venetoclax
    Standard of Care PO (By Mouth)

Первичные конечные точки

  • Rates of Complete Response (CR)/Complete Response with incomplete hematologic recovery (CRi) [Срок оценки: Up to 18 Months]
Вторичные конечные точки (6)
  • Overall Survival (OS) [Срок оценки: Up to 36 Months]
  • Rates to Re-Treatment [Срок оценки: Up to 36 Months]
  • Treatment Free Molecular Remission (TFMR) [Срок оценки: Up to 36 Months]
  • European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30)/Quality of Life (QoL) [Срок оценки: Day 1 (start of enrollment), start of Discontinuation Phase, and monthly until EOT (Up to 36 Months)]
  • Patient Reported Outcome Measurement Information System (PROMIS) [Срок оценки: Day 1 (start of enrollment), start of Discontinuation Phase, and monthly until EOT (Up to 36 Months)]
  • EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) [Срок оценки: Day 1 (start of enrollment), start of Discontinuation Phase, and monthly until EOT (Up to 36 Months)]

Критерии участия

Критерии включения

  • Adults 18 years of age or older at the time of obtaining informed consent.
  • Diagnosed with Acute Myeloid Leukemia (AML) (non-M3) as defined by 2016 World Health Organization (WHO)
  • Eastern Cooperative Group (ECOG) performance status score ≤ 2
  • Currently on frontline therapy with HMA (azacitidine or decitabine)/VEN and achieved Complete Remission (CR)/Complete Remission with incomplete marrow recovery (CRi) with MRD negativity defined as < 0.1% by Multiparameter Flow Cytometry (MFC)
  • Within 12 months of starting HMA (azacitidine or decitabine)/VEN
  • Ineligible for or declined allogeneic hematopoietic cell transplantation (HCT)
  • Ability to understand and the willingness to sign a written informed consent document
  • Must agree to adhere to the study visit schedule and other protocol requirements
  • Patients must be able to provide adequate Bone Marrow (BM) aspirate and biopsy specimens for histopathological and Measurable Residual Disease analysis during the screening procedure

Критерии исключения

  • Use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of AML within 28 days, or 5 half-lives, at the start of the study. Only patients who are receiving frontline HMA (azacitidine or decitabine)/VEN are potentially eligible, but if they had received a course of hydroxyurea prior to achieving CR/CRi, this is allowed.
  • Any serious medical condition or uncontrolled current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or will place the subject at unacceptable risk if he/she participates in the study. Controlled infections or other medical conditions on long-term therapy is allowed.
  • Patients who harbored TP53 mutation at diagnosis
  • AML with extramedullary involvement including central nervous system (CNS) involvement, myeloid sarcoma, and leukemia cutis requiring directed therapy at the time of enrollment.
  • Patient is pregnant.

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

США · 1 центр
  • Moffitt Cancer Center — Tampa

Идентификаторы

NCT: NCT06511882 · MCC-22191

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗