Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

December 16, 2024

Primary Completion Date

June 30, 2028

Study Completion Date

July 31, 2028

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Azacitidine (AZA)

"Dosing is 75 mg/m2 x 7 days (Q28days) After 2 courses, a first decision-making for allo-HCT based on bone marrow MRD assessment will be performed. After 4th course, a new MRD assessment will be performed.~For cohort 1 treatment may continue up to cycle 12 (prioritized over allo-HCT). For cohort 2 treatment may continue up to cycle 24 (prioritizing allo-HCT)"

DRUG

Venetoclax

"Dosing: 400 mg daily After 2 courses, a first decision-making for allo-HCT based on bone marrow MRD assessment will be performed. After 4th course, a new MRD assessment will be performed.~For cohort 1 treatment may continue up to cycle 12 (prioritized over allo-HCT). For cohort 2 treatment may continue up to cycle 24 (prioritizing allo-HCT)"

Trial Locations (14)

17007

RECRUITING

Institut Catala D oncologia Girona, Girona

25196

RECRUITING

Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida, Lleida

28009

RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

43005

RECRUITING

Hospital Universitari Joan XXIII De Tarragona, Tarragona

46010

RECRUITING

Hospital Clinico Universitario De Valencia, Valencia

07120

RECRUITING

University Hospital Son Espases, Palma de Mallorca

07198

RECRUITING

Hospital Son Llatzer, Palma de Mallorca

08916

RECRUITING

Institut Catala D oncologia Badalona, Badalona

08003

RECRUITING

Hospital Del Mar, Barcelona

08025

RECRUITING

Hospital De La Santa Creu I Sant Pau, Barcelona

08035

RECRUITING

Hospital Universitari Vall D Hebron, Barcelona

08036

RECRUITING

Hospital Clinic De Barcelona, Barcelona

08908

RECRUITING

Institut Catala D oncologia Hospitalet, L'Hospitalet de Llobregat

08221

RECRUITING

Fundacio Assistencial De Mutua De Terrassa, Terrassa

All Listed Sponsors
lead

Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

OTHER