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A Phase 1b Study of Bleximenib in Combination with AML Directed Therapies for Participants with Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506582-58-00
Acronym
75276617ALE1002
Enrollment
86
Registered
2024-03-18
Start date
2022-07-21
Completion date
Unknown
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Brief summary

1. Incidence and severity of AEs, including DLTs, 2. Incidence and severity of Aes

Interventions

DRUGCitarabina Hikma 2 g/20mL Soluzione Iniettabile
DRUGIdarubicin Hikma 1 mg/ml Injektionslösung
DRUGVenclyxto 100 mg film-coated tablets
DRUGIdarubicin
DRUGAzacitidine
DRUGCitarabina Hikma 500mg/5mL Soluzione Iniettabile
DRUGVenclyxto 50 mg film-coated tablets
DRUGsolution injectable ou pour perfusion

Sponsors

Janssen - Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Incidence and severity of AEs, including DLTs, 2. Incidence and severity of Aes

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026