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

NCT05317494 | Recruiting

• 1 other identifier: P22-535
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 13

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Venetoclax; Venclexta; Venclyxto; ABT-199; Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Overall Survival (OS)

  OS is defined as the time from treatment initiation to death from any cause.

  Up to 30 Months

Secondary Outcomes (14)

• Percentage of Participants Achieving Composite Complete Remission

  Up to 30 Months

• Total Time of Treatment with Venetoclax Combination Therapy

  Up to 30 Months

• Time to Transfusion Independence

  Up to 30 Months

• Post Baseline RBC and Platelet Transfusion Independence Rate

  Up to 30 Months

• Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important

  Up to 30 Months

Study Arms (1)

Venetoclax Participants

Participants treated with Venetoclax in accordance with approved local label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Greece.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (13)

Olympion General Clinic /ID# 268392

Pátrai, Achaia, 25443, Greece

ACTIVE NOT RECRUITING

General Hospital of Athens Gennimatas /ID# 245968

Athens, Attica, 11527, Greece

ACTIVE NOT RECRUITING

General Hospital of Athens Laiko /ID# 244338

Athens, Attica, 11527, Greece

ACTIVE NOT RECRUITING

University General Hospital Attikon /ID# 248265

Athens, Attica, 12462, Greece

ACTIVE NOT RECRUITING

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

Heraklion, Crete, 71500, Greece

COMPLETED

General University Hospital of Alexandroupolis /ID# 244235

Alexandroupoli, 68100, Greece

ACTIVE NOT RECRUITING

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

Athens, 10676, Greece

ACTIVE NOT RECRUITING

General Anti-cancer Hospital Agios Savvas /ID# 244408

Athens, 11522, Greece

ACTIVE NOT RECRUITING

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

Athens, 11527, Greece

ACTIVE NOT RECRUITING

University General Hospital of Ioannina /ID# 244336

Ioannina, 45500, Greece

ACTIVE NOT RECRUITING

University General Hospital of Patras /ID# 244335

RION Patras Achaia, 26504, Greece

COMPLETED

Papageorgiou General Hospital /ID# 248266

Thessaloniki, 56429, Greece

RECRUITING

General Hospital of Thessaloniki George Papanikolaou /ID# 244237

Thessaloniki, 57010, Greece

ACTIVE NOT RECRUITING

Related Links

• Related Info.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 7, 2022
• Study Start: May 26, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

GR (13)