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 Canada

Launched by ABBVIE · Jun 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called venetoclax, which is used to treat Acute Myeloid Leukemia (AML), a type of blood cancer. The focus of the trial is to see how effective venetoclax is for adults who have recently been diagnosed with AML but are not able to undergo intensive chemotherapy due to various reasons, such as age or health conditions. The study will include around 200 participants at approximately 15-20 locations across Canada.

To be eligible for this trial, participants must have a confirmed diagnosis of AML and be deemed ineligible for intensive chemotherapy by their doctor. Participants will take venetoclax tablets daily for about three years, but there won’t be any extra burdens since all study visits will happen during regular doctor appointments. It’s important to note that participants should not have been part of another clinical trial within 30 days before starting the treatment with venetoclax. Overall, this study aims to provide valuable information on how well venetoclax can help patients with AML who are unable to receive more aggressive treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of Acute Myeloid Leukemia (AML).
• • Ineligible for intensive chemotherapy, determined by the physician's assessment of age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), comorbidities, regional guidelines, and institutional practice.
• • Participant for whom the physician has decided to initiate venetoclax treatment in accordance with the local label. The decision to treat with venetoclax is made by the physician prior to any decision to approach the participant to participate in this study.
• Exclusion Criteria:
• • - Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Trial Officials