Targeting the immune environment in Acute Myeloid Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.