Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax

Launched by GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO · Oct 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well a treatment called Azacitidine combined with Venetoclax works for patients with a type of blood cancer known as acute myeloid leukemia (AML). The main focus is on understanding minimal residual disease (MRD), which refers to tiny amounts of cancer that may remain in the body after treatment. Researchers want to see how quickly the disease responds to this treatment and how MRD affects survival rates. To find this out, they will collect samples from the bone marrow of participants at specific times during their treatment.

To be eligible for this trial, participants must be at least 18 years old and have a newly diagnosed case of AML that hasn't been treated before. They should also plan to receive the Azacitidine and Venetoclax treatment and not be suitable for more intensive chemotherapy. Participants will need to provide consent to join the study and will undergo tests to measure MRD throughout their treatment. This trial aims to help improve understanding of AML treatment and outcomes, which could lead to better care for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject must be ≥ 18 years of age
• • Subject has diagnosis of AML according to WHO 2016
• • Subject has newly diagnosed, previously untreated, AML, including de novo, secondary and therapy-related (cytoreduction with hydroxyurea is admitted prior treatment start)
• • Subject is planned to receive front-line therapy with Azacitidine and Venetoclax
• • Subject is ineligible for intensive induction chemotherapy according to investigator assessment according to clinical practice
• • Subject must have assessable MRD by flow cytometry at screening BM evaluation
• • Signed written informed consent according to ICH/EU/GCP and national local laws
• Exclusion Criteria:
• • Diagnosis of BCR::ABL1-positive AML
• • Diagnosis of APL
• • AML with CNS involvement.
• • AML with extra-medullary localizations
• • Patients' unwillingness or inability to comply with the protocol requirements.