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
Primary completion date changed from estimate of Dec 2026 to May 29, 2026
Enrollment target: estimated 100 to confirmed 106
Secondary endpoints: details revised at 2 of 14 entries
Site details revised at 13 of 13 sites
Eligibility criteria expanded, about 2 words
MinorPrimary and study completion dates: Dec 31, 2026 to Dec 2026v21
MinorRe-verified, no change to tracked fieldsv20
MinorStudy sites: 12 to 13v19
MinorSite details revised at 10 of 12 sitesv18
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MinorStudy sites revised (12)v17
Minor3 versionsRe-verified since Mar 1, 2023, no change to tracked fieldsv14-v16
NotablePrimary completion date: May 30, 2026 to Dec 31, 2026v13
MinorPrimary completion date: Dec 31, 2026 to May 30, 2026v12
NotablePrimary completion date: May 30, 2026 to Dec 31, 2026v11
MinorPrimary completion date: Dec 31, 2026 to May 30, 2026v10
NotablePrimary completion date: May 30, 2026 to Dec 31, 2026
Study sites: 11 to 12
v9
MinorSite details revised at 1 of 11 sitesv8
MinorStudy sites: 10 to 11v7
MinorStudy sites: 9 to 10v6
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MinorStudy sites: 5 to 8v4
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Study completion date: May 30, 2026 to Dec 31, 2026
v3
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 4
Primary and study completion dates: Apr 30, 2026 to May 30, 2026
Start date changed from estimate of May 3, 2022 to May 26, 2022
v2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well Venetoclax works to treat AML in adult participants who are ineligible for intensive chemotherapy in Greece.
Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML who are ineligible for intensive chemotherapy will be enrolled.
Around 100 participants will be enrolled in the study in approximately 15 sites in Greece.
Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 30 months.
There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 30 months.