Active (not recruiting) Phase 3 2024-520154-38-00

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 KMT2ARearrangements or NPM1Mutations who are Ineligible for Intensive Chemotherapy

Phase 3 – large-scale trial before approval

Conditions: Acute Myeloid Luekemia

Sponsor: Janssen Cilag International

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Overview

Trial status: Authorised Dual primary endpoints: CR and OS

Who can participate

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 246 participants

Interventions

JNJ-75276617

Drug

Venclyxto 100 mg film-coated tablets

Drug

matching the 100 mg (G030)

Drug

matching the 30 mg (G031)

Drug

Venclyxto 100 mg film-coated tablets

Drug

Venclyxto 50 mg film-coated tablets

Drug

JNJ-75276617

Drug

JNJ-75276617

Drug

matching the 50 mg (G029)

Drug

JNJ-75276617

Drug

Azacitidine betapharm 25 mg/mL powder for suspension for injection

Drug

Locations 12

Austria (1)

Belgium (1)

Czech Republic (1)

Denmark (1)

France (1)

Germany (1)

Greece (1)

Hungary (1)

Italy (1)

Poland (1)

Portugal (1)

Spain (1)

Status

Active (not recruiting)

Phase

Phase 3

Study type

INTERVENTIONAL

Sex

Male and female

Minimum age

18 Years

Healthy volunteers

Start date

11.07.2025

Registry ID

2024-520154-38-00

Source

euclinicaltrials.eu

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