Clinical trial NCT05317494: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Venetoclax
Venclexta
Venclyxto
ABT-199
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Greece.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Overall Survival (OS)
timeFrame: Up to 30 Months
Secondary outcomes:
measure: Percentage of Participants Achieving Composite Complete Remission
timeFrame: Up to 30 Months
measure: Total Time of Treatment with Venetoclax Combination Therapy
timeFrame: Up to 30 Months
measure: Time to Transfusion Independence
timeFrame: Up to 30 Months
measure: Post Baseline RBC and Platelet Transfusion Independence Rate
timeFrame: Up to 30 Months
measure: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important
timeFrame: Up to 30 Months
measure: Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs)
timeFrame: Up to 30 Months
measure: Healthcare Resource Utilization as the Number of Transfusions (Red Blood Cell [RBC] or Platelets) Received during First-line Treatment in an Outpatient Setting
timeFrame: Up to 30 Months
measure: Healthcare Resource Utilization as the Number of Hospitalizations during First-line Treatment
timeFrame: Up to 30 Months
measure: Healthcare Resource Utilization as the Number of Intensive Care Unit (ICU) Admissions during First-line Treatment
timeFrame: Up to 30 Months
measure: Healthcare Resource Utilization as the Number of Visits in a Private Healthcare Practitioner
timeFrame: Up to 30 Months
measure: Healthcare Resource Utilization as the Name of Relevant Medication due to Infections (Antibiotics or Other)
timeFrame: Up to 30 Months
measure: Healthcare Resource Utilization as the Dosing Scheme of Relevant Medication due to Infections (Antibiotics or Other)
timeFrame: Up to 30 Months
measure: Healthcare Resource Utilization as the Number of Laboratory Tests
timeFrame: Up to 30 Months
measure: Healthcare Resource Utilization as the Type of Laboratory Tests
timeFrame: Up to 30 Months
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Olympion General Clinic /ID# 268392
state: Achaia
city: Athens
country: Greece
facility: General Hospital of Athens Gennimatas /ID# 245968
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 244338
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 248265
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 244337
state: Kriti
city: Alexandroupolis
country: Greece
facility: General University Hospital of Alexandroupolis /ID# 244235
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339
city: Athens
country: Greece
facility: General Anti-cancer Hospital Agios Savvas /ID# 244408
city: Athens
country: Greece
facility: General Hospital of Athens Laiko - Hematology Location /ID# 244234
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina /ID# 244336
city: RION Patras Achaia
country: Greece
facility: University General Hospital of Patras /ID# 244335
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital /ID# 248266
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki George Papanikolaou /ID# 244237
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: