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

Status: Recruiting
Location: See all (13) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Greece
General University Hospital of Alexandroupolis /ID# 244235
ACTIVE_NOT_RECRUITING
Alexandroupoli
General Anti-cancer Hospital Agios Savvas /ID# 244408
ACTIVE_NOT_RECRUITING
Athens
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339
ACTIVE_NOT_RECRUITING
Athens
General Hospital of Athens Gennimatas /ID# 245968
ACTIVE_NOT_RECRUITING
Athens
General Hospital of Athens Laiko - Hematology Location /ID# 244234
ACTIVE_NOT_RECRUITING
Athens
General Hospital of Athens Laiko /ID# 244338
ACTIVE_NOT_RECRUITING
Athens
University General Hospital Attikon /ID# 248265
ACTIVE_NOT_RECRUITING
Athens
University General Hospital of Heraklion PA.G.N.I /ID# 244337
COMPLETED
Heraklion
University General Hospital of Ioannina /ID# 244336
ACTIVE_NOT_RECRUITING
Ioannina
Olympion General Clinic /ID# 268392
ACTIVE_NOT_RECRUITING
Pátrai
University General Hospital of Patras /ID# 244335
COMPLETED
Rion Patras Achaia
General Hospital of Thessaloniki George Papanikolaou /ID# 244237
ACTIVE_NOT_RECRUITING
Thessaloniki
Papageorgiou General Hospital /ID# 248266
RECRUITING
Thessaloniki
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2022-05-26
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
Venetoclax Participants
Participants treated with Venetoclax in accordance with approved local label.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov