Targeting Acute Myeloid Leukemia Immunosuppressive Microenvironment by combinedIDO1 Inhibition and PD-1 Blockade
Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Mar 7, 2025
Trial Information
Current as of May 09, 2025
Recruiting
Keywords
ClinConnect Summary
The clinical trial, titled "Targeting Acute Myeloid Leukemia Immunosuppressive Microenvironment by combined IDO1 Inhibition and PD-1 Blockade," is studying how a combination of two treatments—azacitidine and venetoclax—can help people with acute myeloid leukemia (AML). Researchers want to understand why some patients don't respond well to these treatments, particularly looking at the role of a specific enzyme called IDO1 that might make the cancer environment less responsive to therapy. By examining various biological factors, they hope to learn more about how to improve treatment outcomes for patients with AML.
To participate in this trial, individuals must be at least 18 years old and have a new diagnosis of AML. They should not be eligible for more intensive chemotherapy and will be treated with azacitidine and venetoclax as part of their standard care. Participants can expect to undergo regular assessments and tests to help researchers gather important information about their health and the effects of the treatment. This study is currently recruiting participants, and their findings could lead to better therapies for AML in the future.
Gender
ALL
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
About Irccs Azienda Ospedaliero Universitaria Di Bologna
IRCCS Azienda Ospedaliero-Universitaria di Bologna is a prestigious research and healthcare institution in Italy, renowned for its commitment to advancing medical science and patient care through innovative clinical research. As an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), it integrates clinical practice with scientific research, facilitating the translation of laboratory findings into effective treatment strategies. The institution fosters a multidisciplinary approach, collaborating with various experts to conduct high-quality clinical trials aimed at improving health outcomes across a wide range of medical fields. With a strong emphasis on ethical standards and patient welfare, IRCCS Azienda Ospedaliero-Universitaria di Bologna plays a vital role in shaping the future of medicine through rigorous scientific inquiry and patient-centered care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bologna, , Italy
Patients applied
Trial Officials
Antonio Curti, MD
Principal Investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported