A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Greece

Launched by ABBVIE · Apr 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called Venetoclax for treating adults with Acute Myeloid Leukemia (AML), a type of blood cancer. The trial is specifically for patients who cannot undergo intensive chemotherapy, which is a common treatment for AML. About 100 participants will be enrolled across approximately 15 sites in Greece, and they will take Venetoclax tablets daily for about 30 months. The goal is to see how well this medication helps manage their disease.

To be eligible for this trial, participants must have a new diagnosis of AML and be unable to receive intensive chemotherapy. It’s important that their doctor has already decided to start treatment with Venetoclax before they are approached to join the study. Participants can expect to follow their regular medical appointments, as there is no additional burden from the trial. This study aims to improve treatment options for patients with AML who have limited choices due to their health condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per Greek Ministry of Health (MOH) label.
• • Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study.
• Exclusion Criteria:
• • - Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.