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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-26

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Acute Myeloid Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* Participant diagnosed Acute Myeloid Leukemia (AML) who is ineligible to intensive chemotherapy and is eligible to receive venetoclax as a first-line therapy, as per Greek Ministry of Health (MOH) label.
* 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

\- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status ACTIVE_NOT_RECRUITING

General Hospital of Athens Gennimatas /ID# 245968

Athens, Attica, Greece

Site Status ACTIVE_NOT_RECRUITING

General Hospital of Athens Laiko /ID# 244338

Athens, Attica, Greece

Site Status ACTIVE_NOT_RECRUITING

University General Hospital Attikon /ID# 248265

Athens, Attica, Greece

Site Status ACTIVE_NOT_RECRUITING

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

Heraklion, Crete, Greece

Site Status COMPLETED

General University Hospital of Alexandroupolis /ID# 244235

Alexandroupoli, , Greece

Site Status ACTIVE_NOT_RECRUITING

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

Athens, , Greece

Site Status ACTIVE_NOT_RECRUITING

General Anti-cancer Hospital Agios Savvas /ID# 244408

Athens, , Greece

Site Status ACTIVE_NOT_RECRUITING

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

Athens, , Greece

Site Status ACTIVE_NOT_RECRUITING

University General Hospital of Ioannina /ID# 244336

Ioannina, , Greece

Site Status ACTIVE_NOT_RECRUITING

University General Hospital of Patras /ID# 244335

RION Patras Achaia, , Greece

Site Status COMPLETED

Papageorgiou General Hospital /ID# 248266

Thessaloniki, , Greece

Site Status RECRUITING

General Hospital of Thessaloniki George Papanikolaou /ID# 244237

Thessaloniki, , Greece

Site Status ACTIVE_NOT_RECRUITING

Countries

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Greece

Central Contacts

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ABBVIE CALL CENTER

Role: CONTACT

844-663-3742

Related Links

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Other Identifiers

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P22-535

Identifier Type: -

Identifier Source: org_study_id

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