NCT06874257 Targeting Acute Myeloid Leukemia Immunosuppressive Microenvironment by combinedIDO1 Inhibition and PD-1 Blockade
| NCT ID | NCT06874257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | AML (Acute Myelogenous Leukemia) |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2024-04-17 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: 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
Contact & Investigator
Antonio Curti, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06874257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML (Acute Myelogenous Leukemia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06874257 currently recruiting?
Yes, NCT06874257 is actively recruiting participants. Contact the research team at antonio.curti2@unibo.it for enrollment information.
Where is the NCT06874257 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06874257 clinical trial?
NCT06874257 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Antonio Curti, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 20 participants.
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