AML (Acute Myelogenous Leukemia)NCT06874257
Targeting Acute Myeloid Leukemia Immunosuppressive Microenvironment by combinedIDO1 Inhibition and PD-1 Blockade
An observational study of AML (Acute Myelogenous Leukemia), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The combination of azacitidine and venetoclax is currently considered a therapeutic strategy innovative in AML through the addition of new compounds (triplet therapies), including inhibitors of the immune checkpoint inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- AML (Acute Myelogenous Leukemia)
- What is being tested?
- Laboratory tests and in vitro studies
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 17 Apr 2024to 31 Oct 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The planned population size for the study is of 60 prospectively enrolled AML patients. The project outcomes will be evaluated at T2 and correlated with CR and refractoriness obtained at T2 and with survival data obtained at follow-up. Power analysis conducted using Stata 17 indicated that a sample size of n=60 allows at least 0.90 power for the estimation of a linear regression model with 4 to 10 covariates and an expected R2 of 0.30 to 0.75 with α=0.05. This linear regression model will include as dependent an immune microenvironment variable measured at T2, and as exposure the treatment variable. By including among covariates the baseline values of the dependent variable we expect to obtain high R2 values
Who may be able to join
- Subject is ≥ 18 years of age
- Subject has a new diagnosis of AML according to World Health Organization 2022 criteria
- Subject is ineligible for intensive induction chemotherapy according to investigator assessment
- Subject will undergo front-line treatment with azacitidine and venetoclax according to normal clinical practice
- Subject providing signed written informed consent according to ICH/EU/GCP and national local laws
- For healthy donors:
- Age ≥ 18 years
- Subject providing signed written informed consent according to ICH/EU/GCP and national local laws
Who cannot join
- For patients:
- Subject has acute promyelocytic leukemia
- Subject has known AML with central nervous system involvement
- Subject has not initiated treatment with azacitidine and venetoclax
- For healthy donors:
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Antonio Curti, MD, +39 0512144074, antonio.curti2@unibo.it
About this study
The combination of azacitidine and venetoclax is currently considered a therapeutic strategy innovative in AML through the addition of new compounds (triplet therapies), including inhibitors of the immune checkpoint inhibitors. Despite strong motivation, the clinical results of these approaches have been disappointing overall. The mechanisms leading to treatment failure of immunotherapies in AML are poorly elucidated as the effects on the AML microenvironment induced by basic azactidine and venetoclax therapy are largely unknown. In particular, the activity of the IDO1 enzyme as a potential mechanism of microenvironment resistance has been scarcely studied. The products of the IDO1-catalysed pathway activate the signalling of the AHR in mesenchymal stem cells and enhance their immunosuppressive effects, including the ability to reprogram the phenotype of M1/M2 macrophages. Furthermore, activation of the AHR by by products of the IDO1 pathway kinurenine-promotes tolerogenic dendritic cells and the generation of regulatory T cells. Based on this rationale, TALETE-2023 will aim to analyse the leukaemia immune microenvironment through multiomics (epigenomics transcriptomics, proteomics, metabolomics) and assess its contribution to the effect of the combination of azacitidine and venetoclax.
Read the detailed description
Study Objective: To decipher the cellular composition of the bone marrow microenvironment before and after treatment with azacitidine and venetoclax. Objective 2: To functionally validate the cellular composition of the bone marrow environment and its contribution in response to treatment using an in vitro model. Objective 3: To evaluate the association between the cellular composition of the bone marrow environment and the achievement of clinical response. Objective 4: To investigate whether the cellular composition of the bone marrow environment and its contribution in response to treatment is associated with lower survival at 18 months. The primary endpoint will be the discovery of the mechanisms of the microenvironment of susceptibility to immunotherapy and their correlation with clinical response (achievement of CR or refractoriness) and survival data. More specifically:
- Pan-tissue AHR signature - Pan-tissue AHR signature levels will be measured at T1 and T2 using iterative cycles of computational biology analysis and experimental validation. In particular, expression levels will be measured and a cut-off will be set for genes differentially expressed at log2 fold change;
- The expression level of IFN-y in AML cells (% positive cells) and IDO1 in MSCs (mRNA levels mRNA levels) will be measured at T1 and T2. The expression of IDO1 will be measured in relation to the infiltration of Treg into the bone marrow. A cutoff for IFN-y and IDO1 expression will be set at 30% with fold-change>2 at T2 over T1;
- The effects of IDO1 inhibitor on metabolic reactivation of effector T cells will be measured at T1 and T2 via mTOR activation. The following parameters will be measured in percentage: 1) glucose dependence, 2) mitochondrial dependence 3) glycolytic capacity and 4) fatty acid and AA oxidation capacity to determine the metabolic state. It will be evaluated the fold change between T2 and T1 of these 4 parameters; STUDY DESIGN This is a prospective, multicentre, tissue-based study aimed at collecting and characterising human tissues isolated from patients with acute myeloid leukaemia, who will receive azacitidine and venetoclax as the standard treatmentv as part of normal clinical practice. Specifically, in addition to the visits as part of normal clinical practice, samples of 80 mL of PB, 45 mL of BM and 1.5 mL of urine in addition to the scheduled blood samples. Samples will be collected at diagnosis (T1) and at the time of treatment response assessment = after the second cycle with azacitidine and venetoclax (T2). Treatment response will be assessed on the basis of the criteria standard response criteria for acute myeloid leukaemia according to the 2022 recommendations of a group of international experts on behalf of European LeukemiaNet25.Patients will be followed up for survival data. The source of survival data will be the patient's medical record. The study will include newly diagnosed, untreated adult patients with acute myeloid leukaemia who are not eligible for chemotherapy, candidates to receive the combination of venetoclax and azacitidine according to standard clinical practice and regardless of study participation. Patients will be enrolled at the time of disease diagnosis. For healthy donors, a total of a total of 60 buffy coats over 24 months. All patients who do not receive treatment (T2) will be excluded from the study. All 60 patients will be considered for the For objectives 2, 3 and 4, only patients who have completed both cycles of therapy will be considered. who have completed both cycles of therapy. The enrolment period of the subjects participating study subjects will be 18 months, the sample collection period will be 2 months, the clinical data analysis period will be 4 months, the clinical data analysis period will be 4 months, the follow-up period will be 12 months, for a total study duration of 36 months.
The study is funded by 'TRANSCAN-3 ERA-NET: supported collaboration of national national and regional programmes in cancer research'; Joint Transnational Call 2021 (JTC 2021) co-funded by the European Commission/DG Research and Innovation: 'Next generation cancer immunotherapy: Targeting the tumour microenvironment'.
- Conditions
- AML (Acute Myelogenous Leukemia)
- Being tested
- Laboratory tests and in vitro studies
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory tests and in vitro studiesBiological
Cell models, co-culture condition set-up and functional validation, Single-cell RNA sequencing and NGS, Metabolomics analysis, metabolomics validation and intracellular metabolomics analysis, Metabolic ImmunoProfiling and epigenetic profile, CyTOF immune and signaling profiling, Monocyte, macrophages and MSCs in vitro assays.
| Study group | Role | What they receive |
|---|---|---|
| Patien with AML | The study will include untreated and newly diagnosed unfit-to-chemotherapy, adult AML patients candidate to receive the combination of venetoclax plus azacitidine according to standard clinical practice, and independently of the participation to the study. The patients will be enrolled at the time of disease diagnosis. For healthy donors, a total of 60 buffy coats will be collected in time period of 24 months. Patients who will not receive any treatment will be excluded from the study Receives: Biological: Laboratory tests and in vitro studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pan-tissue AHR signature
Pan-tissue AHR signature levels will be measured by using iterative cycles of computational biology analyses and experimental validation (24). In particular, the levels of expression will be detected and a cutoff for differentially expressed genes will be set at log2 fold change.
Measured: At visit 1 (T1, diagnosis), and after the second cycle with azacitidine and venetoclax (T2, 2 months after treatment initiation)
IFN-y pathway response
Expression level of IFN-y in AML cells (% of positive cells) and IDO1 in MSCs (mRNA levels) will be measured. IDO1 expression will be measured in relation to BM Treg infiltration (25).A cutoff for IFN-y and IDO1 expression will be set at 30% with fold-change>2 at T2 over T1.
Measured: At visit 1 (T1), and after the second cycle with azacitidine and venetoclax (T2, 2 months after treatment initiation)
Immunometabolic shift in T-cells
The effects of IDO1 inhibitor for the metabolic re activation of effector T cells will be measured via mTOR activation. We will measure the following parameters as percentages(%): 1) glucose dependence, 2) mitochondrial dependence 3) glycolytic capacity and 4) fatty acid and AA oxidation capacity to determine the metabolic status. The fold change between T2 and T1 of these 4 parameters will be evaluated.
Measured: At visit 1 (T1), and after the second cycle with azacitidine and venetoclax (T2, 2 months after treatment initiation)
Clinical response
- Complete Remission (CR): BM blasts <5%; absence of circulating blasts or blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 x 109
- L (1,000/μL); platelet count ≥100 x 109
- L (100,000/μL)
- CR with partial hematologic recovery (CRh): ANC ≥0.5 x 109
- L (500/μL) and platelet count ≥50 x 109
- L (50,000/μL), otherwise all other CR criteria met
- CR with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia <1.0 x 109
- L (1,000/μL) or thrombocytopenia <100 x 109
- L (100,000/μL)
- Refractoriness: No CR, CRh or CRi
Measured: After the second cycle with azacitidine and venetoclax (T2, 2 months after treatement initiation )
Survival (Aim 4)
OS (%, months) and RFS (%, months)
Measured: At follow-up (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start17 Apr 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myelogenous Leukemia)Studies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Curti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874257
- Sponsor's protocol ID
- TALETE-2023
- Other IDs
- 3000506
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Acute Myeloid Leukemia Immunosuppressive Microenvironment by combinedIDO1 Inhibition and PD-1 Blockade
- ClinicalTrials.gov ID
- NCT06874257
- Acronym / sponsor ID
- TALETE-2023
- Conditions
- AML (Acute Myelogenous Leukemia)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Mar 2025 (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 combination of azacitidine and venetoclax is currently considered a therapeutic strategy innovative in AML through the addition of new compounds (triplet therapies), including inhibitors of the immune checkpoint inhibitors. Despite strong motivation, the clinical results of these approaches have been disappointing overall. The mechanisms leading to treatment failure of immunotherapies in AML are poorly elucidated as the effects on the AML microenvironment induced by basic azactidine and venetoclax therapy are largely unknown. In particular, the activity of the IDO1 enzyme as a potential mechanism of microenvironment resistance has been scarcely studied. The products of the IDO1-catalysed pathway activate the signalling of the AHR in mesenchymal stem cells and enhance their immunosuppressive effects, including the ability to reprogram the phenotype of M1/M2 macrophages. Furthermore, activation of the AHR by by products of the IDO1 pathway kinurenine-promotes tolerogenic dendritic cells and the generation of regulatory T cells. Based on this rationale, TALETE-2023 will aim to analyse the leukaemia immune microenvironment through multiomics (epigenomics transcriptomics, proteomics, metabolomics) and assess its contribution to the effect of the combination of azacitidine and venetoclax.
Detailed description
Study Objective: To decipher the cellular composition of the bone marrow microenvironment before and after treatment with azacitidine and venetoclax. Objective 2: To functionally validate the cellular composition of the bone marrow environment and its contribution in response to treatment using an in vitro model. Objective 3: To evaluate the association between the cellular composition of the bone marrow environment and the achievement of clinical response. Objective 4: To investigate whether the cellular composition of the bone marrow environment and its contribution in response to treatment is associated with lower survival at 18 months. The primary endpoint will be the discovery of the mechanisms of the microenvironment of susceptibility to immunotherapy and their correlation with clinical response (achievement of CR or refractoriness) and survival data. More specifically:
- Pan-tissue AHR signature - Pan-tissue AHR signature levels will be measured at T1 and T2 using iterative cycles of computational biology analysis and experimental validation. In particular, expression levels will be measured and a cut-off will be set for genes differentially expressed at log2 fold change;
- The expression level of IFN-y in AML cells (% positive cells) and IDO1 in MSCs (mRNA levels mRNA levels) will be measured at T1 and T2. The expression of IDO1 will be measured in relation to the infiltration of Treg into the bone marrow. A cutoff for IFN-y and IDO1 expression will be set at 30% with fold-change>2 at T2 over T1;
- The effects of IDO1 inhibitor on metabolic reactivation of effector T cells will be measured at T1 and T2 via mTOR activation. The following parameters will be measured in percentage: 1) glucose dependence, 2) mitochondrial dependence 3) glycolytic capacity and 4) fatty acid and AA oxidation capacity to determine the metabolic state. It will be evaluated the fold change between T2 and T1 of these 4 parameters; STUDY DESIGN This is a prospective, multicentre, tissue-based study aimed at collecting and characterising human tissues isolated from patients with acute myeloid leukaemia, who will receive azacitidine and venetoclax as the standard treatmentv as part of normal clinical practice. Specifically, in addition to the visits as part of normal clinical practice, samples of 80 mL of PB, 45 mL of BM and 1.5 mL of urine in addition to the scheduled blood samples. Samples will be collected at diagnosis (T1) and at the time of treatment response assessment = after the second cycle with azacitidine and venetoclax (T2). Treatment response will be assessed on the basis of the criteria standard response criteria for acute myeloid leukaemia according to the 2022 recommendations of a group of international experts on behalf of European LeukemiaNet25.Patients will be followed up for survival data. The source of survival data will be the patient's medical record. The study will include newly diagnosed, untreated adult patients with acute myeloid leukaemia who are not eligible for chemotherapy, candidates to receive the combination of venetoclax and azacitidine according to standard clinical practice and regardless of study participation. Patients will be enrolled at the time of disease diagnosis. For healthy donors, a total of a total of 60 buffy coats over 24 months. All patients who do not receive treatment (T2) will be excluded from the study. All 60 patients will be considered for the For objectives 2, 3 and 4, only patients who have completed both cycles of therapy will be considered. who have completed both cycles of therapy. The enrolment period of the subjects participating study subjects will be 18 months, the sample collection period will be 2 months, the clinical data analysis period will be 4 months, the clinical data analysis period will be 4 months, the follow-up period will be 12 months, for a total study duration of 36 months.
The study is funded by 'TRANSCAN-3 ERA-NET: supported collaboration of national national and regional programmes in cancer research'; Joint Transnational Call 2021 (JTC 2021) co-funded by the European Commission/DG Research and Innovation: 'Next generation cancer immunotherapy: Targeting the tumour microenvironment'.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patien with AML | – | Biological: Laboratory tests and in vitro studiesThe study will include untreated and newly diagnosed unfit-to-chemotherapy, adult AML patients candidate to receive the combination of venetoclax plus azacitidine according to standard clinical practice, and independently of the participation to the study. The patients will be enrolled at the time of disease diagnosis. For healthy donors, a total of 60 buffy coats will be collected in time period of 24 months. Patients who will not receive any treatment will be excluded from the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The planned population size for the study is of 60 prospectively enrolled AML patients. The project outcomes will be evaluated at T2 and correlated with CR and refractoriness obtained at T2 and with survival data obtained at follow-up. Power analysis conducted using Stata 17 indicated that a sample size of n=60 allows at least 0.90 power for the estimation of a linear regression model with 4 to 10 covariates and an expected R2 of 0.30 to 0.75 with α=0.05. This linear regression model will include as dependent an immune microenvironment variable measured at T2, and as exposure the treatment variable. By including among covariates the baseline values of the dependent variable we expect to obtain high R2 values
Key inclusion criteria (8 listed)
- Subject is ≥ 18 years of age
- Subject has a new diagnosis of AML according to World Health Organization 2022 criteria
- Subject is ineligible for intensive induction chemotherapy according to investigator assessment
- Subject will undergo front-line treatment with azacitidine and venetoclax according to normal clinical practice
- Subject providing signed written informed consent according to ICH/EU/GCP and national local laws
Key exclusion criteria (6 listed)
- Subject has acute promyelocytic leukemia
- Subject has known AML with central nervous system involvement
- Subject has not initiated treatment with azacitidine and venetoclax
- None
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 |
|---|---|---|
| Laboratory tests and in vitro studiesCell models, co-culture condition set-up and functional validation, Single-cell RNA sequencing and NGS, Metabolomics analysis, metabolomics validation and intracellular metabolomics analysis, Metabolic ImmunoProfiling and epigenetic profile, CyTOF immune and signaling profiling, Monocyte, macrophages and MSCs in vitro assays. | Biological | Patien with AML |
Primary outcome
Pan-tissue AHR signature
Time frame: At visit 1 (T1, diagnosis), and after the second cycle with azacitidine and venetoclax (T2, 2 months after treatment initiation)
Pan-tissue AHR signature levels will be measured by using iterative cycles of computational biology analyses and experimental validation (24). In particular, the levels of expression will be detected and a cutoff for differentially expressed genes will be set at log2 fold change.
IFN-y pathway response
Time frame: At visit 1 (T1), and after the second cycle with azacitidine and venetoclax (T2, 2 months after treatment initiation)
Expression level of IFN-y in AML cells (% of positive cells) and IDO1 in MSCs (mRNA levels) will be measured. IDO1 expression will be measured in relation to BM Treg infiltration (25).A cutoff for IFN-y and IDO1 expression will be set at 30% with fold-change>2 at T2 over T1.
Immunometabolic shift in T-cells
Time frame: At visit 1 (T1), and after the second cycle with azacitidine and venetoclax (T2, 2 months after treatment initiation)
The effects of IDO1 inhibitor for the metabolic re activation of effector T cells will be measured via mTOR activation. We will measure the following parameters as percentages(%): 1) glucose dependence, 2) mitochondrial dependence 3) glycolytic capacity and 4) fatty acid and AA oxidation capacity to determine the metabolic status. The fold change between T2 and T1 of these 4 parameters will be evaluated.
Clinical response
Time frame: After the second cycle with azacitidine and venetoclax (T2, 2 months after treatement initiation )
1. Complete Remission (CR): BM blasts <5%; absence of circulating blasts or blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 x 109 * L (1,000/μL); platelet count ≥100 x 109 * L (100,000/μL) 2. CR with partial hematologic recovery (CRh): ANC ≥0.5 x 109 * L (500/μL) and platelet count ≥50 x 109 * L (50,000/μL), otherwise all other CR criteria met 3. CR with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia <1.0 x 109 * L (1,000/μL) or thrombocytopenia <100 x 109 * L (100,000/μL) 4. Refractoriness: No CR, CRh or CRi
Survival (Aim 4)
Time frame: At follow-up (up to 12 months)
OS (%, months) and RFS (%, months)
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 13 Mar 2025.
Related trials for AML (Acute Myelogenous Leukemia)
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML (Acute Myelogenous Leukemia), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
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 Antonio Curti, MD (+39 0512144074, antonio.curti2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pan-tissue AHR signature (time frame: At visit 1 (T1, diagnosis), and after the second cycle with azacitidine and venetoclax (T2, 2 months after treatment initiation)). The study lists 5 primary outcomes in all. 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 13 Mar 2025.