Targeting the immune environment in Acute Myeloid Leukemia
Targeting Acute Myeloid Leukemia Immunosuppressive Microenvironment by combinedIDO1 Inhibition and PD-1 Blockade
This study is testing how the bone marrow environment affects treatment outcomes in people with Acute Myeloid Leukemia who are receiving azacitidine and venetoclax, to see if understanding this can improve immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06874257 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the cellular composition of the bone marrow microenvironment in patients with Acute Myeloid Leukemia (AML) before and after treatment with azacitidine and venetoclax. It will explore the role of the IDO1 enzyme and its impact on the immune response and treatment outcomes. By analyzing the relationship between the microenvironment and clinical responses, the study seeks to uncover mechanisms that contribute to treatment resistance and survival rates. The findings may help to better understand how to enhance immunotherapy effectiveness in AML.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a new diagnosis of AML who are ineligible for intensive chemotherapy and will receive azacitidine and venetoclax.
Not a fit: Patients with acute promyelocytic leukemia or those with known AML involving the central nervous system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with AML by enhancing the effectiveness of immunotherapy.
How similar studies have performed: While there have been studies exploring immunotherapy in AML, the specific combination of IDO1 inhibition and PD-1 blockade in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Antonio Curti, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Antonio Curti, MD
- Email: antonio.curti2@unibo.it
- Phone: +39 0512144074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.