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

Last updated: July 15, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Platelet Disorders

Acute Myeloid Leukemia

Treatment

N/A

Clinical Study ID

NCT05317494
P22-535
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensivechemotherapy and is eligible to receive venetoclax as a first-line therapy, as perGreek Ministry of Health (MOH) label.

  • Physician has decided to initiate venetoclax treatment. The decision to treat withvenetoclax is made by the physician in accordance with the local label prior to anydecision to approach the patient to participate in this study.

Exclusion

Exclusion Criteria:

  • Participating in an interventional clinical trial within 30 days prior to venetoclaxtreatment initiation.

Study Design

Total Participants: 100
Study Start date:
May 26, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Olympion General Clinic /ID# 268392

    Patras, Achaia 25443
    Greece

    Site Not Available

  • General Hospital of Athens Gennimatas /ID# 245968

    Athens, Attiki 11527
    Greece

    Site Not Available

  • General Hospital of Athens Laiko /ID# 244338

    Athens, Attiki 11527
    Greece

    Site Not Available

  • University General Hospital Attikon /ID# 248265

    Athens, Attiki 12462
    Greece

    Site Not Available

  • University General Hospital of Heraklion PA.G.N.I /ID# 244337

    Heraklion, Kriti 71500
    Greece

    Completed

  • Papageorgiou General Hospital Thessaloniki /ID# 248266

    Stavroupoli (Thessalonikis), Thessaloniki 55536
    Greece

    Site Not Available

  • General University Hospital of Alexandroupolis /ID# 244235

    Alexandroupolis, 68100
    Greece

    Site Not Available

  • General Anti-cancer Hospital Agios Savvas /ID# 244408

    Athens, 11522
    Greece

    Site Not Available

  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339

    Athens, 10676
    Greece

    Site Not Available

  • General Hospital of Athens Laiko - Hematology Location /ID# 244234

    Athens, 11527
    Greece

    Site Not Available

  • University General Hospital of Ioannina /ID# 244336

    Ioannina, 45500
    Greece

    Site Not Available

  • University General Hospital of Patras /ID# 244335

    RION Patras Achaia, 26504
    Greece

    Completed

  • General Hospital of Thessaloniki George Papanikolaou /ID# 244237

    Thessaloniki, 57010
    Greece

    Site Not Available

  • Papageorgiou General Hospital /ID# 248266

    Thessaloniki, 56429
    Greece

    Active - Recruiting

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