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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

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

Study ID: NCT05317494

Interventions

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

General Hospital of Athens Gennimatas /ID# 245968, Athens, Attiki, Greece

General Hospital of Athens Laiko /ID# 244338, Athens, Attiki, Greece

University General Hospital Attikon /ID# 248265, Athens, Attiki, Greece

University General Hospital of Heraklion PA.G.N.I /ID# 244337, Heraklion, Kriti, Greece

General University Hospital of Alexandroupolis /ID# 244235, Alexandroupolis, , 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

Contact Details

Name: ABBVIE INC.

Affiliation: AbbVie

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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