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RECRUITING
NCT05317494

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

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective Non-Interventional Study to Describe the Effectiveness and Safety of Venetoclax as a First-Line Treatment in Acute Myeloid Leukemia (AML) Patients Who Are Ineligible to Intensive Chemotherapy in Routine Clinical Practice in Greece

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2022-05-26

Completion Date

2026-12

Last Updated

2025-07-16

Healthy Volunteers

No

Locations (13)

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