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
NCT ID: NCT05317494
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-05-26
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Venetoclax Participants
Participants treated with Venetoclax in accordance with approved local label.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Olympion General Clinic /ID# 268392
Pátrai, Achaia, Greece
General Hospital of Athens Gennimatas /ID# 245968
Athens, Attica, Greece
General Hospital of Athens Laiko /ID# 244338
Athens, Attica, Greece
University General Hospital Attikon /ID# 248265
Athens, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 244337
Heraklion, Crete, Greece
General University Hospital of Alexandroupolis /ID# 244235
Alexandroupoli, , Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339
Athens, , Greece
General Anti-cancer Hospital Agios Savvas /ID# 244408
Athens, , Greece
General Hospital of Athens Laiko - Hematology Location /ID# 244234
Athens, , Greece
University General Hospital of Ioannina /ID# 244336
Ioannina, , Greece
University General Hospital of Patras /ID# 244335
RION Patras Achaia, , Greece
Papageorgiou General Hospital /ID# 248266
Thessaloniki, , Greece
General Hospital of Thessaloniki George Papanikolaou /ID# 244237
Thessaloniki, , Greece
Countries
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Central Contacts
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Related Links
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Related Info.
Other Identifiers
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P22-535
Identifier Type: -
Identifier Source: org_study_id
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