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Active (not recruiting) Phase 3 2025-522767-15-00

HOVON 181 AML: 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

Phase 3 – large-scale trial before approval
Conditions: Acute Myeloid Leukemia

Sponsor: Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

trial.available_in: БГ
Overview
Trial status: Authorised EFS, defined as the time from randomization to failure to achieve CR after remission induction, hematologic relapse after achieving CR, or death, whichever occurs first.
Who can participate
Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 385 participants
Interventions
placebo to match bleximenib 100 mg
Drug
Placebo to match bleximenib 50 mg
Drug
JNJ-75276617
Drug
JNJ-75276617
Drug
Locations 12
Austria (1)
Belgium (1)
Denmark (1)
Estonia (1)
Finland (1)
Germany (1)
Italy (1)
Lithuania (1)
Netherlands (1)
Norway (1)
Poland (1)
Sweden (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.01.2026
Registry ID
2025-522767-15-00
Source
euclinicaltrials.eu
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