Идёт набор NCT06852222

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Фаза III С лечением Leukemia, Myeloid, Acute

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: Bleximenib, Venetoclax (VEN), Azacitidine (AZA), Placebo.
Кому может быть актуально: Состояния в реестре: Leukemia, Myeloid, Acute. 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, Австралия, Австрия, Бельгия, Бразилия +20
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

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy

Обзор

The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.

Вмешательства

Препарат Bleximenib
Bleximenib will be administered orally.
Препарат Venetoclax (VEN)
VEN will be administered orally.
Препарат Azacitidine (AZA)
AZA will be administered intravenously or subcutaneously.
Препарат Placebo
Placebo will be administered orally.

Первичные конечные точки

Percentage of Participants who Achieve Complete Remission (CR) [Срок оценки: Up to 4 years and 1 month]
Overall Survival (OS) [Срок оценки: Up to 4 years and 1 month]

Вторичные конечные точки (9)

Event-free survival (EFS) [Срок оценки: Up to 4 years and 1 month]
Duration of CR [Срок оценки: Up to 4 years and 1 month]
Time to CR [Срок оценки: Up to 4 years and 1 month]
Rate of CR Without Measurable Residual Disease (MRD-) [Срок оценки: Up to 4 years and 1 month]
Percentage of Participants who Achieved Transfusion Independence [Срок оценки: Up to 4 years and 1 month]
Percentage of Participants with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT) [Срок оценки: Up to 4 years and 1 month]
Number of Participants with Adverse Events (AEs) [Срок оценки: Up to 4 years and 1 month]
Number of Participants with Abnormalities in Clinical Laboratory Parameters [Срок оценки: Up to 4 years and 1 month]
Serum Concentration of Bleximenib [Срок оценки: Up to 4 years and 1 month]

Критерии участия

Критерии включения

Be 18 years of age or older at the time of informed consent
Previously untreated lysine N-methyltransferase 2A gene rearranged (KMT2Ar) or nucleophosmin 1 gene mutated (NPM1m) acute myeloid leukemia (AML) with greater than or equal to (> or =) 10% bone marrow blasts per 2022 international Consensus Classification criteria
Ineligible for intensive chemotherapy based on the following criteria: a) >= 75 years of age and ineligible per physician's discretion, with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, b) >=18 to <75 years of age with >= 1 of the following comorbidities: i) ECOG performance status of 2, ii) Severe cardiac disorder, iii) Severe pulmonary disorder, iv) Renal impairment, v) Moderate hepatic impairment vi) Comorbidity that, in the investigator's opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment as defined in the protocol. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
Participants must have adequate hepatic and renal function
A female participant must agree not to be pregnant, breast-feed, plan to become pregnant and use protocol-specified contraception while enrolled in this study and for 6 months after the last dose of study treatment
A male participant must agree to use protocol-specified contraception while enrolled in this study for at least 90 days after the last dose of study treatment
Must sign an informed consent form indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Критерии исключения

Diagnosis of acute promyelocytic leukemia (APL)
Known active leukemic involvement of the central nervous system (CNS)
Recipient of solid organ transplant
Any cardiac disorders such as heart attack, uncontrolled/unstable chest pain, congestive heart failure, uncontrolled or symptomatic irregular heartbeat, blockage of a blood vessel to brain, or transient ischemic (decreased oxygen in tissue) attack within 6 months of randomization
Active infectious hepatitis
Live, attenuated vaccine within 4 weeks of randomization
Known allergies, hypersensitivity, or intolerance of bleximenib, azacitidine, or venetoclax excipients

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Тройное слепое
Основная цель: Лечение