Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation

Официальное название

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation

Обзор

The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.

Вмешательства

• Препарат Revumenib
  Participants will receive revumenib orally.
• Препарат Placebo
  Participants will receive placebo (non-active agent) orally.
• Препарат Intensive Chemotherapy Regimen
  Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.

Первичные конечные точки

• Event Free Survival [Срок оценки: Up to 2 years]
• Measurable Residual Disease Complete Remission Rate [Срок оценки: Up to 2 years]

Вторичные конечные точки (9)

• Overall Survival [Срок оценки: Up to 5 years]
• Rate of Complete Remission [Срок оценки: Up to 2 years]
• Rate of Composite Complete Remission [Срок оценки: Up to 2 years]
• Overall Response Rate [Срок оценки: Up to 2 years]
• Duration of Complete Remission [Срок оценки: Up to 2 years]
• Duration of Composite Complete Remission [Срок оценки: Up to 2 years]
• Duration of Response [Срок оценки: Up to 2 years]
• Number of Participants with a Treatment-emergent Adverse Event [Срок оценки: Up to 2 years]
• Change from Baseline in Patient-reported Fatigue Questionnaire Scores [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy.
• Presence of an NPM1 mutation.
• Eastern Cooperative Oncology Group performance status ≤2 (≤1 if >65 years old); Karnofsky or Lansky ≥40.
• Have a life expectancy of ≥3 months as judged by the Investigator.
• Negative serum pregnancy test.
• Adequate liver, kidney, and cardiac function.

Критерии исключения

• Diagnosis of active acute promyelocytic leukemia.
• Active central nervous system disease.
• Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
• Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.
• Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).
• Inability to swallow oral medication.
• Pregnant or nursing females.
• Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Италия · 15 центров

• Clinical Trial Site — Monza
• Clinical Trial Site — Alessandria
• Clinical Trial Site — Bergamo
• Clinical Trial Site — Bologna
• Clinical Trial Site — Candiolo
• Clinical Trial Site — Florence
• Clinical Trial Site — Meldola
• Clinical Trial Site — Milan
• … и ещё 7 центров

Испания · 15 центров

• Clinical Trial Site — Las Palmas de Gran Canaria
• Clinical Trial Site — Oviedo
• Clinical Trial Site — Badalona
• Clinical Trial Site — Barcelona
• Clinical Trial Site — Burgos
• Clinical Trial Site — Cáceres
• Clinical Trial Site — Granada
• Clinical Trial Site — Madrid
• … и ещё 7 центров

Австралия · 5 центров

• Clinical Trial Site — Melbourne
• Clinical Trial Site — Nedlands
• Clinical Trial Site — Perth
• Clinical Trial Site — Gosford
• Clinical Trial Site — Wollongong

Грузия · 5 центров

• Clinical Trial Site — Batumi
• Clinical Trial Site — Tbilisi
• Clinical Trial Site 1 — Tbilisi
• Clinical Trial Site 2 — Tbilisi
• Clinical Trial Site — Tbilisi

Германия · 5 центров

• Clinical Trial Site — Tübingen
• Clinical Trial Site — Düsseldorf
• Clinical Trial Site — Herne
• Clinical Trial Site — Jena
• Clinical Trial Site — Hamburg

Израиль · 5 центров

• Clinical Trial Site — Petah Tikva
• Clinical Trial Site — Tel Aviv
• Clinical Trial Site — Haifa
• Clinical Trial Site — Jerusalem
• Clinical Trial Site — Jerusalem

Румыния · 5 центров

• Clinical Trial Site — Târgu Mureş
• Clinical Trial Site — Bucharest
• Clinical Trial Site — Bucharest
• Clinical Trial Site — Cluj-Napoca
• Clinical Trial Site — Iași

South Korea · 5 центров

• Clinical Trial Site — Busan
• Clinical Trial Site — Busan
• Clinical Trial Site — Goyang-si
• Clinical Trial Site — Seoul
• Clinical Trial Site — Seoul

Великобритания · 5 центров

• Clinical Trial Site — Aberdeen
• Clinical Trial Site — Derby
• … и ещё 3 центра

Австрия · 4 центра

• Clinical Trial Site — Sankt Pölten
• Clinical Trial Site — Graz
• Clinical Trial Site — Leoben
• Clinical Trial Site — Linz

Бразилия · 4 центра

• Clinical Trial Site — Fortaleza
• Clinical Trial Site — Barretos
• Clinical Trial Site — Jaú
• Clinical Trial Site — Porto Alegre

Франция · 3 центра

• Clinical Trial Site — Angers
• Clinical Trial Site — Bayonne
• Clinical Trial Site — Bordeaux

Малайзия · 3 центра

• Clinical Trial Site — Johor Bahru
• Clinical Trial Site — Petaling Jaya
• Clinical Trial Site — Subang Jaya

Канада · 2 центра

• Clinical Trial Site — Montreal
• Clinical Trial Site — Toronto

Бельгия · 1 центр

• Clinical Trial Site — Ghent

Венгрия · 1 центр

• Clinical Trial Site — Győr

Идентификаторы

NCT: NCT07211958 · SNDX-5613-0710 · 2025-522279-27-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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