AML, AdultNCT06090786
Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax
A study testing MRD assessment in people with AML, Adult and Minimal Residual Disease, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Trial summary
The goal of this no-profit, multicenter, biological, non-pharmacologic study is to evaluate minimal residual disease (MRD) in patients treated with Azacitidine and Venetoclax according to clinical practice. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult, Minimal Residual Disease
- What is being tested?
- MRD assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2027
- Phase
- Interventional
- 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
- Subject must be ≥ 18 years of age
- Subject has diagnosis of AML according to WHO 2016
- Subject has newly diagnosed, previously untreated, AML, including de novo, secondary and therapy-related (cytoreduction with hydroxyurea is admitted prior treatment start)
- Subject is planned to receive front-line therapy with Azacitidine and Venetoclax
- Subject is ineligible for intensive induction chemotherapy according to investigator assessment according to clinical practice
- Subject must have assessable MRD by flow cytometry at screening BM evaluation
- Signed written informed consent according to ICH/EU/GCP and national local laws
Who cannot join
- Diagnosis of BCR::ABL1-positive AML
- Diagnosis of APL
- AML with CNS involvement.
- AML with extra-medullary localizations
- Patients' unwillingness or inability to comply with the protocol requirements.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicentric, Prospective Study Addressing the Kinetics and Impact on Survival of Measurable Residual Disease in Acute Myeloid Leukemia Patients Receiving Azacitidine and Venetoclax
The goal of this no-profit, multicenter, biological, non-pharmacologic study is to evaluate minimal residual disease (MRD) in patients treated with Azacitidine and Venetoclax according to clinical practice.
The main questions it aims to answer are:
- kinetics of disease response on treatment with Azacitidine and Venetoclax through the evaluation of MRD with both cytofluorimetric and molecular techniques
- impact of MRD on survival outcomes. To this end, bone marrow samples will be collected at pre-defined time-points during treatment and MRD will be assessed.
Read the detailed description
This is a multicentric biological study at evaluating MRD kinetics during treatment with Azacitidine and Venetoclax as well as the impact of MRD on survival outcomes.
Newly diagnosed, previously untreated, patients with AML, including de novo, secondary and therapy-related, receiving front-line therapy with Azacitidine and Venetoclax according to clinical practice will be included.
Response assessment will be performed on BM aspirate according to ELN2022 response criteria. MRD evaluation will be performed on BM at pre-defined time-points during treatment. MRD assessment will be performed centrally in order to harmonize response evaluation.
- Conditions
- AML, Adult, Minimal Residual Disease
- Being tested
- MRD assessment
- Keywords
- Venetoclax, Azacitidine, AML, Minimal rsidual disease
- 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.
MRD assessmentDiagnostic test
Bone marrow withdrawal for MRD quantification
| Study group | Role | What they receive |
|---|---|---|
| MRD evaluation | Other | Evaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax Receives: Diagnostic Test: MRD assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of MRD-negative patients within cycle 4
Number of patients without minimal residual disease within cycle 4 on the total of subjects receiving at least one dose of study medication
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study startJul 2024 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Curti, Principal investigator, Division of Hematology IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090786
- Sponsor's protocol ID
- AML2723
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Prospective Study Addressing the Kinetics and Impact on Survival of Measurable Residual Disease in Acute Myeloid Leukemia Patients Receiving Azacitidine and Venetoclax
- ClinicalTrials.gov ID
- NCT06090786
- Acronym / sponsor ID
- AML2723
- Conditions
- AML, Adult, Minimal Residual Disease
- Keywords
- Venetoclax, Azacitidine, AML, Minimal rsidual disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Oct 2023 (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 goal of this no-profit, multicenter, biological, non-pharmacologic study is to evaluate minimal residual disease (MRD) in patients treated with Azacitidine and Venetoclax according to clinical practice.
The main questions it aims to answer are:
- kinetics of disease response on treatment with Azacitidine and Venetoclax through the evaluation of MRD with both cytofluorimetric and molecular techniques
- impact of MRD on survival outcomes. To this end, bone marrow samples will be collected at pre-defined time-points during treatment and MRD will be assessed.
Detailed description
This is a multicentric biological study at evaluating MRD kinetics during treatment with Azacitidine and Venetoclax as well as the impact of MRD on survival outcomes.
Newly diagnosed, previously untreated, patients with AML, including de novo, secondary and therapy-related, receiving front-line therapy with Azacitidine and Venetoclax according to clinical practice will be included.
Response assessment will be performed on BM aspirate according to ELN2022 response criteria. MRD evaluation will be performed on BM at pre-defined time-points during treatment. MRD assessment will be performed centrally in order to harmonize response evaluation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRD evaluation | Other | Diagnostic Test: MRD assessmentEvaluation of MRD at pre-defined timepoints in AML patients treated with Azacitidine and Venetoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be ≥ 18 years of age
- Subject has diagnosis of AML according to WHO 2016
- Subject has newly diagnosed, previously untreated, AML, including de novo, secondary and therapy-related (cytoreduction with hydroxyurea is admitted prior treatment start)
- Subject is planned to receive front-line therapy with Azacitidine and Venetoclax
- Subject is ineligible for intensive induction chemotherapy according to investigator assessment according to clinical practice
Key exclusion criteria (5 listed)
- Diagnosis of BCR::ABL1-positive AML
- Diagnosis of APL
- AML with CNS involvement.
- AML with extra-medullary localizations
- Patients' unwillingness or inability to comply with the protocol requirements.
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 |
|---|---|---|
| MRD assessmentBone marrow withdrawal for MRD quantification | Diagnostic test | MRD evaluation |
Primary outcome
Rate of MRD-negative patients within cycle 4
Time frame: 4 months
Number of patients without minimal residual disease within cycle 4 on the total of subjects receiving at least one dose of study medication
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 10 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Antonio Curti principal investigator
Division of Hematology IRCCS Azienda Ospedaliero-Universitaria di Bologna
Questions about this trial
What is this clinical trial studying?
A study testing MRD assessment in people with AML, Adult and Minimal Residual Disease, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Paola Fazi (0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of MRD-negative patients within cycle 4 (time frame: 4 months). 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 10 Apr 2024.