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

NCT05768711 Phase 2 ACTIVE_NOT_RECRUITING

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

Details

Lead sponsor	Groupe Francophone des Myelodysplasies
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	44
Start date	2023-10-04
Completion	2028-10

Conditions

• Chronic Myeloid Leukemia

Interventions

• Venetoclax

Primary outcomes

• Safety run-in — after 2 cycles of treatment of the safety run-in phase patients (each cycle is 28 days)
  Determination of dose-limiting toxicities within the first two cycles of treatment
• Overall response rate — after 3 and 6 cycles of treatment of the phase II patients (each cycle is 28 days)
  Overall response encompasses complete remission, partial remission, marrow response and clinical benefit according to protocol-defined criteria modified from MDS/MPN IWG criteria after 3 and 6 cycles of treatment

Countries

France