WHO ICTRP trial

Study of safety and efficacy of Venetoclax in combination with Vidaza…

CTIS2024-514878-53-00 · EU Clinical Trials Information System · Not Recruiting

Key facts

Trial ID CTIS2024-514878-53-00
Public title Study of safety and efficacy of Venetoclax in combination with Vidaza (Azacitidine) in higher-risk Chronic Myelomonocytic Leukemia (CMML)
Scientific title AVENHIR trial: Phase II study with safety run-in of Azacitidine (AZA) combined with Venetoclax (VEN) in patients with higher-risk Chronic Myelomonocytic Leukemia (CMML) - AVENHIR
Primary sponsor Groupe Francophone Des Myelodysplasies
Registry EU Clinical Trials Information System
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): Yes Therapeutic confirmatory - (Phase III): No Therapeutic use - (Phase IV): No
Countries France
Conditions Newly diagnosed, HMA-naïve, higher-risk (HR, defined as CPSS risk intermediate-2 or high) CMML patients MedDRA version: 21.0Level: LLTClassification code: 10054350Term: Chronic myelomonocytic leukemia Class: 10029104;Therapeutic area…
Interventions Product Name: Vidaza 25 mg/ml powder for suspension for injection, Product Code:PRD9244549, Pharmaceutical Form: SUSPENSION FOR INJECTION, Other descriptive name: , Strength: , Product Name: Venetoclax, Product Code:PRD2186235…
Registration date Sep 9, 2024
Target size 44
Secondary IDs NCT05768711;2021-002007-35
Registry page euclinicaltrials.eu

At a glance

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