Acute Myeloid LeukemiaPhase 2VERDINCT06668558
Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia
A Phase 2 study testing Azacitidine (AZA) and Venetoclax in people with Acute Myeloid Leukemia, run by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias at 14 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Azacitidine (AZA) and Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 14 sitesSpain
- Study dates
- 16 Dec 2024to Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have confirmation of with acute myeloid leukemia (AML) with persistent measurable residual disease (MRD) or MRD reappearance after frontline intensive chemotherapy (including at least one cycle of cytarabine and anthracycline), and prior to allogeneic hematopoietic cell transplantation (allo-HCT).
- In patients with NPM1 mutation, qRT-PCR of NPM1 will be the method used to establish a molecular failure, defined as failure to achieve molecular response after consolidation therapy (NPM1mut/ABL1·100 \> 0.1) or MRD reappearance after molecular response. All cases of molecular failure must be confirmed with a second MRD assessment in 2 to 4 weeks.
- In patients with core-binding factor AML, qRT-BCR of RUNX1-RUNX1T1 and CBFb-MYH11 transcripts will be used. Patients failing to achieve a major MRD reduction after consolidation therapy (i.e., RUNX1-RUNX1T1/ABL1·100\>0.1 or CBFb-MYH11/ABL1·100\>0.1), a log increase in MRD between two positive samples or confirmed MRD reappearance after molecular response will be considered as molecular failures and could be included in the trial.
- In the remaining cases, an appropriate leukemia-associated immunophenotype (LAIP) measured by multiparameter flow cytometry will be used for MRD surveillance. A cutoff of 0.1% will be used to define MRD positivity.
- Age ≥18 years.
- Without clinical signs of active central nervous system disease.
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- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤2 or Karnofsky performance status (KPS) equivalent.
- Patients must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
- Patients must have adequate liver function as demonstrated by:
- aspartate aminotransferase (AST) ≤ 3.0 × upper limit normal (ULN)
- alanine aminotransferase (ALT) ≤ 3.0 × ULN
- bilirubin ≤ 1.5 × ULN, unless due to Gilbert\'s syndrome
- Non-sterile male patients must use contraceptive methods with partner(s) prior to beginning study drug administration and continuing up to 3 months after the last dose of study drug. Male patients must agree to refrain from sperm donation from initial study drug administration until 3 months after the last dose of study drug.
- WOCBP must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting therapy; 2) throughout the entire duration of treatment; 3) during dose interruptions; and 4) for at least 6 months after discontinuation of therapy (last dose of study drug).
- Patients must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed screening procedures.
Who cannot join
- Patient has received other prior rescue treatment for MRD.
- Patient is known to be positive for Human immunodeficiency virus (HIV) infection with the exception of those with an undetectable viral load under correct virological control throughout the study.
- Note: HIV testing is not required.
- Patient is known to be positive for hepatitis B (HBV) or C (HCV) infection with the exception of those with an undetectable viral load.
- Note: Hepatitis B or C testing is not required and patients with serologic evidence of prior vaccination to HBV (i.e., HBsAg-, anti-HBs+ and anti-HBc-) may participate.
- Patient has known active central nervous system (CNS) involvement from AML.
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- Patient has received within 7 days prior to the first dose of study drug: steroid therapy ≥ 20 mg/day (prednisone or equivalent) for antineoplastic intent; strong and moderate CYP3A inhibitors; strong and moderate CYP3A inducers.
- Patient has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the initiation of study treatment.
- Patient has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
- New York Heart Association heart failure \> class 2.
- Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
- Patient has a malabsorption syndrome or other condition that precludes the enteral route of administration.
- Patient exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
- Patient has a history of other malignancies within the prior year to study entry, except for:
- Adequately treated in situ carcinoma of the breast or cervix uteri.
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin.
- Prostate cancer with no plans for therapy of any kind.
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- Pregnant and breastfeeding females.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Institut Catala D oncologia Badalona
Badalona, Catalonia, 08916
Hospital Del Mar
Barcelona, Catalonia, 08003
Hospital De La Santa Creu I Sant Pau
Barcelona, Catalonia, 08025
Hospital Universitari Vall D Hebron
Barcelona, Catalonia, 08035
Hospital Clinic De Barcelona
Barcelona, Catalonia, 08036
Institut Catala D oncologia Girona
Girona, Catalonia, 17007
Institut Catala D oncologia Hospitalet
L'Hospitalet de Llobregat, Catalonia, 08908
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Lleida, Catalonia, 25196
Hospital General Universitario Gregorio Maranon
Madrid, Madrid, 28009
University Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
Hospital Universitari Joan XXIII De Tarragona
Tarragona, Catalonia, 43005
Fundacio Assistencial De Mutua De Terrassa
Terrassa, Catalonia, 08221
Hospital Clinico Universitario De Valencia
Valencia, Valencia, 46010
About this study
Official title: 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)
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.
Read the detailed description
The trial will enroll competitively between 25 and 29 patients.
Patients will be recruited in two independent cohorts depending on the pre-established time point for the intervention and ELN risk subtype:
Cohort 1: Patients diagnosed with a favorable ELN subtype AML, not intended for alloHCT in first complete remission (CR1), but who present an MRD failure by after frontline intensive chemotherapy, as defined in the 2021 update on MRD guidelines elaborated by the European LeukemiaNet MRD Working Party (Heuser et al. 2023):
In patients with persistent low-level MRD (\<2%) after consolidation chemotherapy, an increase of MRD ≥1log10 between 2 positive samples Confirmed MRD conversion of MRD negativity to MRD positivity AML during subsequent follow-up (up to 3 years after chemotherapy completion
Cohort 2: Patients diagnosed with a non-favorable ELN AML subtype, intended to undergo alloHCT, in first complete morphological remission but harboring detectable MRD at time of alloHCT (\>0.1%).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Azacitidine (AZA), Venetoclax
- Keywords
- venetoclax, azacitidine, measurable residual disease (MRD), allogeneic hematopoietic cell transplantation (alloHCT)
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine (AZA)Drug
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)
VenetoclaxDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients diagnosed with a favorable ELN subtype AML, not intended for alloHCT in CR1, but who present an MRD failure by after frontline intensive chemotherapy, as defined in the 2021 update on MRD guidelines elaborated by the European LeukemiaNet MRD Working Party (Heuser et al. 2021) Receives: Drug: Azacitidine (AZA); Drug: Venetoclax |
| Cohort 2 | Experimental | Patients diagnosed with a non-favorable ELN AML subtype, intended to undergo alloHCT, in first complete morphological remission but harboring detectable MRD at time of alloHCT (>0.1%) Receives: Drug: Azacitidine (AZA); Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MRD conversion after 2 to 4 courses of study treatment
Defined as the percentage of patients who achieve MRD clearance after 2-4 courses of study treatment. Failure to achieve MRD negativity after 4 courses will be considered a treatment failure.
Measured: After the administration of 2 and 4 cycles (i.e. approximately 2 and 4 months after. Throughout the study period (up to 3 years) the initiation of study treatment)
Secondary outcomes (4)
Duration of MRD response
Defined as the time elapsed from the first obtention of MRD clearance until MRD progression. Confirmed MRD conversion from MRD negativity to MRD positivity will be performed during subsequent follow-up.
Measured: Throughout the study period, up to 3 years after chemotherapy completion. Throughout the study period (up to 3 years)
Relapse risk after intervention
Defined as the time elapsed from the intervention for AML until confirmed hematological relapse.
Measured: Throughout the study period, up to 3 years after chemotherapy completion. Throughout the study period (up to 3 years)
Safety profile
Incidence of Treatment-Emergent Adverse Events Percentage of patients experiencing treatment-related adverse events (AEs).
Measured: Throughout the study period, up to 3 years after chemotherapy completion. Throughout the study period (up to 3 years)
Treatment Compliance
Percentage of patients experiencing AEs that lead to dose modifications, including treatment interruption, delays and dose reductions.
Measured: Throughout the study period, up to 3 years after chemotherapy completion. Throughout the study period (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start16 Dec 2024
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- investigator-initiated, multicenter, multicohort, phase II trial
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordi Esteve, M.D.; Ph.D., Study chair, Hematology department Institute Clínic of Hematological and Oncological diseases (ICMHO) Hospital Clínic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668558
- Sponsor's protocol ID
- CETLAM-LMA-AC-2024-01
- Other IDs
- 2024-510648-29-00
- Acronym
- VERDI
- Status last verified
- Sep 2026
- First submitted
- 29 Oct 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To protect confidentiality of patients the IPD will be restricted and only shared upon reasonable request if the purposes of this request complies with the conditions agreed with patients consent.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06668558
- Acronym / sponsor ID
- VERDI / CETLAM-LMA-AC-2024-01
- Conditions
- Acute Myeloid Leukemia
- Keywords
- venetoclax, azacitidine, measurable residual disease (MRD), allogeneic hematopoietic cell transplantation (alloHCT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y MielodisplasiasUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial will enroll competitively between 25 and 29 patients.
Patients will be recruited in two independent cohorts depending on the pre-established time point for the intervention and ELN risk subtype:
Cohort 1: Patients diagnosed with a favorable ELN subtype AML, not intended for alloHCT in first complete remission (CR1), but who present an MRD failure by after frontline intensive chemotherapy, as defined in the 2021 update on MRD guidelines elaborated by the European LeukemiaNet MRD Working Party (Heuser et al. 2023):
In patients with persistent low-level MRD (\<2%) after consolidation chemotherapy, an increase of MRD ≥1log10 between 2 positive samples Confirmed MRD conversion of MRD negativity to MRD positivity AML during subsequent follow-up (up to 3 years after chemotherapy completion
Cohort 2: Patients diagnosed with a non-favorable ELN AML subtype, intended to undergo alloHCT, in first complete morphological remission but harboring detectable MRD at time of alloHCT (\>0.1%).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- investigator-initiated, multicenter, multicohort, phase II trial
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Azacitidine (AZA), Drug: VenetoclaxPatients diagnosed with a favorable ELN subtype AML, not intended for alloHCT in CR1, but who present an MRD failure by after frontline intensive chemotherapy, as defined in the 2021 update on MRD guidelines elaborated by the European LeukemiaNet MRD Working Party (Heuser et al. 2021) |
| Cohort 2 | Experimental | Drug: Azacitidine (AZA), Drug: VenetoclaxPatients diagnosed with a non-favorable ELN AML subtype, intended to undergo alloHCT, in first complete morphological remission but harboring detectable MRD at time of alloHCT (>0.1%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have confirmation of with acute myeloid leukemia (AML) with persistent measurable residual disease (MRD) or MRD reappearance after frontline intensive chemotherapy (including at least one cycle of cytarabine and anthracycline), and prior to allogeneic hematopoietic cell transplantation (allo-HCT).
- Age ≥18 years.
- Without clinical signs of active central nervous system disease.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤2 or Karnofsky performance status (KPS) equivalent.
- Patients must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
Key exclusion criteria (19 listed)
- Patient has received other prior rescue treatment for MRD.
- Patient is known to be positive for Human immunodeficiency virus (HIV) infection with the exception of those with an undetectable viral load under correct virological control throughout the study.
- Note: HIV testing is not required.
- Patient is known to be positive for hepatitis B (HBV) or C (HCV) infection with the exception of those with an undetectable viral load.
- Note: Hepatitis B or C testing is not required and patients with serologic evidence of prior vaccination to HBV (i.e., HBsAg-, anti-HBs+ and anti-HBc-) may participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Cohort 1, Cohort 2 |
| VenetoclaxDosing: 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) | Drug | Cohort 1, Cohort 2 |
Primary outcome
Rate of MRD conversion after 2 to 4 courses of study treatment
Time frame: After the administration of 2 and 4 cycles (i.e. approximately 2 and 4 months after. Throughout the study period (up to 3 years) the initiation of study treatment)
Defined as the percentage of patients who achieve MRD clearance after 2-4 courses of study treatment. Failure to achieve MRD negativity after 4 courses will be considered a treatment failure.
4 secondary outcomes
Duration of MRD response
Time frame: Throughout the study period, up to 3 years after chemotherapy completion. Throughout the study period (up to 3 years)
Relapse risk after intervention
Time frame: Throughout the study period, up to 3 years after chemotherapy completion. Throughout the study period (up to 3 years)
Safety profile
Time frame: Throughout the study period, up to 3 years after chemotherapy completion. Throughout the study period (up to 3 years)
Treatment Compliance
Time frame: Throughout the study period, up to 3 years after chemotherapy completion. Throughout the study period (up to 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided. To protect confidentiality of patients the IPD will be restricted and only shared upon reasonable request if the purposes of this request complies with the conditions agreed with patients consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Esteve, M.D.; Ph.D. study chair
Hematology department Institute Clínic of Hematological and Oncological diseases (ICMHO) Hospital Clínic of Barcelona
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine (AZA) and Venetoclax in people with Acute Myeloid Leukemia, run by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MRD conversion after 2 to 4 courses of study treatment (time frame: After the administration of 2 and 4 cycles (i.e. approximately 2 and 4 months after. Throughout the study period (up to 3 years) the initiation of study treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.