NCT Number: NCT04813263
Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. This study will assess how safe and effective oral venetoclax is in participants with AML. Adverse events and change in disease activity will be monitored under routine clinical practice.
Venetoclax is an approved drug to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan.
Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets.
There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.
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Observational
Anjou Kousei Hospital /ID# 244213, Anjo-shi, Aichi-ken, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
None
Time frame: Up to 52 weeks.
Percentage of participants with a high grade (≥ Grade 3) protocol specified neutropenia during and after treatment with venetoclax.
Time frame: Up to 52 weeks
Percentage of participants with protocol specified febrile neutropenia and thrombocytopenia during and after treatment with venetoclax.
Time frame: Up to 52 weeks
Percentage of participants with protocol specified TLS during and after treatment with venetoclax.
Time frame: Up to 52 weeks
Grade 3 and above AE/ADR are serious adverse event (SAE) that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to 52 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated.
Time frame: Up to 52 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated.
Time frame: Up to 52 weeks
Composite Complete remission (CRc) is defined as Complete Remission (CR) + CRi (CR with incomplete blood count recovery) based on protocol criteria.
Time frame: Up to 52 weeks.
Time to Best Response is measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.
Time frame: Up to 52 weeks
Median time for duration of oral venetoclax treatment in participants with Acute Myeloid Leukemia.
Time frame: Up to 52 weeks
Time from the date of first oral Venetoclax intake to the date of death from any cause.
Time frame: Up to 52 weeks
Time from the date of first oral Venetoclax intake and the date of the assessment having documented Complete Remission with incomplete Hematologic recovery (CRi).
AbbVie
Industry
A Post-marketing Observational Study for Venetoclax in Patients Diagnosed With Acute Myeloid Leukemia in Japan
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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