RecruitingNCT05317494

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

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


Sponsor

AbbVie

Enrollment

100 participants

Start Date

May 26, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an observational study in Greece tracking how AML (acute myeloid leukemia) patients who are unable to tolerate intensive chemotherapy respond to venetoclax — a targeted oral medication approved as a first-line treatment for this patient group. The study collects real-world data on how the drug performs outside of clinical trials. **You may be eligible if...** - You have been diagnosed with AML - Your doctor has determined you are not a candidate for intensive chemotherapy - Your doctor has already decided to prescribe venetoclax as part of your standard care, in line with the Greek Ministry of Health approved label **You may NOT be eligible if...** - You are currently participating in another interventional clinical trial within 30 days of starting venetoclax Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT05317494


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