Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)
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, Cytarabine, Daunorubicin or Idarubicin, Placebo.
- 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, Австралия, Бельгия, Эстония, Финляндия +4
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Bleximenib or Placebo in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for the Treatment of Patients With Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a Double-blind Phase 3 Study
Обзор
The current standard of care treatment for adult patients with acute myeloid leukemia (AML) consists of chemotherapy and, if indicated, donor stem cell transplantation. Bleximenib blocks the interaction between a protein called menin and another protein called KMT2A in the leukemia cells. When this interaction is disrupted in AML with mutations in the NPM1 or KMT2A gene, bleximenib can cause leukemia cells to die. The main objective is to assess if treatment with bleximenib, when added to chemotherapy treatment will improve treatment outcome in adult participants with newly diagnosed AML who present with mutations in the NPM1 or KMT2A genes. This is a randomized, double-blind, placebo-controlled, phase 3 clinical trial. All of the participants will receive standard chemotherapy treatment, combined with either bleximenib or a placebo. A placebo is a substance that looks like the study medicine but has no active ingredients (e.g., a sugar pill). In a double blind trial neither the participant nor the doctor know if placebo or active study drug is given. After the end of the protocol treatment there will be an observational follow-up of 4 years from the time of inclusion of the last patient. The results of the different treatment groups will be compared. 875 previously untreated patients with AML with a specific change in the DNA of the leukemia cells (a KMT2A rearrangement or a NPM1 mutation) will be included. Participants must be 18 years or older and considered eligible for intensive chemotherapy.
Вмешательства
- Препарат Bleximenib
Participants will receive bleximenib - Препарат Cytarabine
Participants will receive Cytarabine - Препарат Daunorubicin or Idarubicin
Participants will receive Daunorubicin or Idarubicin - Препарат Placebo
Participants will receive Placebo
Первичные конечные точки
- Event-Free Survival (EFS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy [Срок оценки: Up to 4 years and 5 months]
Вторичные конечные точки (4)
- Overall Survival (OS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy [Срок оценки: Up to 7 years and 10 months]
- Rates of CR, CRh, CRi in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy [Срок оценки: Up to 7 years and 10 months]
- Prolongation of CR (DoCR) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy [Срок оценки: Up to 4 years and 5 months]
- Percentage of participants undergoing an allo-SCT in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy [Срок оценки: Up to 7 years and 10 months]
Критерии участия
Критерии включения
- ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informed consent.
- New diagnosis of AML (≥10% blasts in BM or peripheral blood) with mutated NPM1 or with recurring rearrangements involving KMT2A according to ICC 2022 criteria.
- Considered eligible for intensive chemotherapy.
- WHO/ECOG performance status ≤2.
- Adequate renal and hepatic functions prior to randomization.
Критерии исключения
- Prior (chemo-)therapy for AML, including prior treatment with hypomethylating agents
- Known active leukemic involvement of the central nervous system (CNS).
- Recipient of solid organ transplant.
- Cardiac disease:
- Any of the following within 6 months of randomization: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (NYHA Class III or IV), uncontrolled or symptomatic arrhythmias, stroke, or transient ischemic attack.
- QTc interval using Fridericia's formula (QTcF) ≥470 ms. Prolonged QTc interval associated with bundle branch block or pacemaking is permitted.
- Left ventricular ejection fraction (LVEF) <40% by ECHO or MUGA scan obtained within 28 days prior to the start of study treatment.
- Previously received cumulative dose of any combination of anthracyclines or anthracenediones of ≥500 mg/m2.
- Chronic respiratory disease requiring supplemental oxygen.
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Нидерланды · 15 центров
- NL-Amersfoort-MEANDERMC — Amersfoort
- NL-Amsterdam-AMSTERDAMUMC — Amsterdam
- NL-Amsterdam-OLVG — Amsterdam
- NL-Arnhem-RIJNSTATE — Arnhem
- NL-Breda-AMPHIA — Breda
- NL-Dordrecht-ASZ — Dordrecht
- NL-Eindhoven-MAXIMAMC — Eindhoven
- NL-Groningen-UMCG — Groningen
- … и ещё 7 центров
Бельгия · 12 центров
- BE-Antwerpen-UZA — Antwerp
- BE-Antwerpen-ZAS — Antwerp
- BE-Brugge-AZBRUGGE — Bruges
- BE-Brussel-BORDET — Brussels
- Be-Charleroi-GHDC — Charleroi
- BE-Geel-STDIMPNA — Geel
- BE-Gent-UZGENT — Ghent
- BE-Haine-Saint-Paul-JOLIMONT — Jolimont
- … и ещё 4 центра
Германия · 10 центров
- DE-Aachen-UKAACHEN — Aachen
- DE-Bochum-RUB — Bochum
- DE-Bonn-UNIBONN — Bonn
- DE-Greifswald-UNIGREIFSWALD — Greifswald
- DE-Halle-UMH — Halle
- DE-Hannover-MHHANNOVER — Hanover
- DE-Heilbronn-SLK — Heilbronn
- DE-Karlsruhe-KLINIKUMKARLSRUHE — Karlsruhe
- … и ещё 2 центра
Австралия · 9 центров
- AU-Adelaide-FLINDERS — Adelaide
- AU-Adelaide-RAH — Adelaide
- AU-Birtinya-SUNSHINECOAST — Birtinya
- AU-Brisbane-PAH — Brisbane
- AU-Camperdown-RPA — Camperdown
- AU-Melbourne-AUSTIN — Melbourne
- AU-Melbourne-MONASH — Melbourne
- AU-Melbourne-PMCC — Melbourne
- … и ещё 1 центр
США · 8 центров
- US-San Francisco CA-UCSF — San Francisco
- US-Orlando FL-ORLANDOHEALTH — Orlando
- US-Atlanta GA-EMORY — Atlanta
- US-Chigago IL-UHCHICAGO — Chicago
- US-Kansas City KS-KUMC — Kansas City
- US-Baltimore MD-UMGCCC — Baltimore
- US-St Louis MO-WASHU — St Louis
- US-Cincinnati OH-CINCY — Cincinnati
Япония · 4 центра
- JP-Chuo-Ku-CHIBA — Chūōku
- JP-Nagasaki Shi-NAGASAKI — Nagasaki
- JP-Nishi-Gun-YAMAGATA — Yamagata
- JP-Yoshida-Gun-FUKUI — Yoshida
Эстония · 2 центра
- EE-Tallinn-REGIONAALHAIGLA — Tallinn
- EE-Tartu-TARTU — Tartu
Финляндия · 2 центра
- FI-Oulu-OYS — Oulu
- FI-Tampere-TAYS — Tampere
Швеция · 1 центр
- SE-Lund-Suh — Lund
Идентификаторы
NCT: NCT07223814 · HOVON 181 AML · 2025-522767-15-00