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Active Not RecruitingNCT05768711

Azacitidine Combined With Venetoclax in Patients With Higher-risk Chronic Myelomonocytic Leukemia (AVENHIR)

Phase II Study With Safety run-in of Azacitidine (AZA) Combined With Venetoclax (VEN) in Patients With Higher-risk Chronic Myelomonocytic Leukemia (CMML)

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
44 (estimated)
Sponsor
Groupe Francophone des Myelodysplasies · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Open-label phase II, single arm, multicenter study with safety run-in to evaluate the efficacy and safety of Azacitidine combined with Venetoclax in patients with higher-risk chronic myelomonocytic leukemia

Detailed description

AVENHIR trial is an open-label phase II, single arm, multicenter study with safety run-in to evaluate the efficacy and safety of the combination of Azacitidine and Venetoclax in, hypomethylating agent-naïve, higher-risk chronic myelomonocytic leukemia patients

Conditions

Interventions

TypeNameDescription
DRUGVenetoclaxCombination of Azacitidine and Venetoclax

Timeline

Start date
2023-10-04
Primary completion
2026-05-01
Completion
2028-10-01
First posted
2023-03-14
Last updated
2026-03-05

Locations

24 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05768711. Inclusion in this directory is not an endorsement.

Azacitidine Combined With Venetoclax in Patients With Higher-risk Chronic Myelomonocytic Leukemia (AVENHIR) (NCT05768711) · Clinical Trials Directory