RecruitingPhase 2NCT06668558

Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia

Preemptive Treatment With Venetoclax Plus Azacitidine in Patients Diagnosed With Acute Myeloid Leukemia (AML) With Persistence or Reappearance of Measurable Residual Disease (MRD) After Frontline Chemotherapy and High-level MRD Prior to Allogeneic Hematopoietic Cell Transplantation (alloHCT)

Sponsor

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

Enrollment

29 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

The VERDI study is an investigator-initiated, multicenter, multicohort, phase II trial with combination of venetoclax + azacitidine for patients treated for AML under according to an intensive chemotherapy protocol (CETLAM-20) failing to achieve or maintain MRD negativity at pre-established time-points: at chemotherapy completion for ELN favorable subtypes, and prior to alloHCT for non-favorable European LeukemiaNet (ELN) AML patients. The primary objective is to determine Ven/Aza treatment activity in MRD clearance in patients diagnosed with AML with persistent MRD or MRD reappearance after frontline chemotherapy, or prior to alloHCT.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug combination — venetoclax plus azacitidine — for people with acute myeloid leukemia (AML, a blood cancer) who have had initial intensive chemotherapy but still show traces of leukemia cells in their blood or bone marrow (called measurable residual disease, or MRD). The goal is to eliminate those remaining cancer cells before a bone marrow transplant. **You may be eligible if...** - You are 18 or older with AML that is in partial remission but still shows residual disease after intensive chemotherapy - You have not yet had a bone marrow transplant - You are in acceptable health (ECOG ≤ 2) with adequate kidney and liver function - You do not have active central nervous system involvement from AML **You may NOT be eligible if...** - Your AML is in full remission with no residual disease - You have already had a bone marrow transplant - Your organ function is outside acceptable limits - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine (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)

DRUGVenetoclax

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)

Locations(14)

University Hospital Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Institut Catala D oncologia Badalona

Badalona, Catalonia, Spain

Hospital Del Mar

Barcelona, Catalonia, Spain

Hospital De La Santa Creu I Sant Pau

Barcelona, Catalonia, Spain

Hospital Universitari Vall D Hebron

Barcelona, Catalonia, Spain

Hospital Clinic De Barcelona

Barcelona, Catalonia, Spain

Institut Catala D oncologia Girona

Girona, Catalonia, Spain

Institut Catala D oncologia Hospitalet

L'Hospitalet de Llobregat, Catalonia, Spain

Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida

Lleida, Catalonia, Spain

Hospital Universitari Joan XXIII De Tarragona

Tarragona, Catalonia, Spain

Fundacio Assistencial De Mutua De Terrassa

Terrassa, Catalonia, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Madrid, Spain

Hospital Clinico Universitario De Valencia

Valencia, Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06668558

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