Actively Recruiting
Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
Led by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias · Updated on 2025-09-19
29
Participants Needed
14
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed acute myeloid leukemia (AML) with persistent or reappearing measurable residual disease (MRD) after frontline intensive chemotherapy
- Molecular failure confirmed by a second MRD test within 2 to 4 weeks (for NPM1 mutation or core-binding factor AML)
- Age 18 years or older
- No active central nervous system disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, or Karnofsky performance status equivalent
- Adequate kidney function with creatinine clearance of 30 mL/min or higher
- Adequate liver function with AST and ALT levels up to 3 times the upper limit of normal, and bilirubin up to 1.5 times the upper limit unless due to Gilbert's syndrome
- Male patients who are not sterile must use contraception during and up to 3 months after treatment, and agree to avoid sperm donation during that time
- Women of childbearing potential must use two reliable contraception methods or abstain from heterosexual intercourse from 28 days before treatment through 6 months after treatment ends
- Signed informed consent approved by an Institutional Review Board (IRB)
You will not qualify if you...
- Previous rescue treatment for measurable residual disease (MRD)
- Known HIV infection unless viral load is undetectable and controlled
- Known hepatitis B or C infection unless viral load is undetectable
- Active central nervous system involvement by AML
- Use of steroids (≥20 mg/day prednisone or equivalent) for cancer treatment or strong/moderate CYP3A inhibitors or inducers within 7 days before treatment
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before treatment
- Significant medical conditions that may interfere with study participation, including heart failure worse than class 2, kidney, neurologic, psychiatric, endocrine, metabolic, immune, liver, heart, or bleeding disorders unrelated to leukemia
- Malabsorption syndrome or conditions preventing oral medication
- Uncontrolled infections requiring treatment
- Other cancers within the past year except certain treated skin, cervical, or prostate cancers or previously cured malignancies
- Pregnancy or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 14 locations
1
University Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120
Actively Recruiting
2
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain, 07198
Actively Recruiting
3
Institut Catala D oncologia Badalona
Badalona, Catalonia, Spain, 08916
Actively Recruiting
4
Hospital Del Mar
Barcelona, Catalonia, Spain, 08003
Actively Recruiting
5
Hospital De La Santa Creu I Sant Pau
Barcelona, Catalonia, Spain, 08025
Actively Recruiting
6
Hospital Universitari Vall D Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
7
Hospital Clinic De Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
8
Institut Catala D oncologia Girona
Girona, Catalonia, Spain, 17007
Actively Recruiting
9
Institut Catala D oncologia Hospitalet
L'Hospitalet de Llobregat, Catalonia, Spain, 08908
Actively Recruiting
10
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Lleida, Catalonia, Spain, 25196
Actively Recruiting
11
Hospital Universitari Joan XXIII De Tarragona
Tarragona, Catalonia, Spain, 43005
Actively Recruiting
12
Fundacio Assistencial De Mutua De Terrassa
Terrassa, Catalonia, Spain, 08221
Actively Recruiting
13
Hospital General Universitario Gregorio Maranon
Madrid, Madrid, Spain, 28009
Actively Recruiting
14
Hospital Clinico Universitario De Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
Research Team
A
A responsible person Designated by the sponsor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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