Status:
RECRUITING
Targeting Acute Myeloid Leukemia Immunosuppressive Microenvironment by combinedIDO1 Inhibition and PD-1 Blockade
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
AML (Acute Myelogenous Leukemia)
Eligibility:
All Genders
18+ years
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 im...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06874257
Start Date
April 17 2024
End Date
October 31 2026
Last Update
March 13 2025
Active Locations (1)
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1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138