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

Acute Myeloid Leukemia Clinical Trial

— SURVIVE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05317494
• Other study ID #: P22-535
• Status: Recruiting
• Start date: May 26, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Greece	General University Hospital of Alexandroupolis /ID# 244235	Alexandroupolis
Greece	General Anti-cancer Hospital Agios Savvas /ID# 244408	Athens
Greece	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339	Athens
Greece	General Hospital of Athens Gennimatas /ID# 245968	Athens	Attiki
Greece	General Hospital of Athens Laiko - Hematology Location /ID# 244234	Athens
Greece	General Hospital of Athens Laiko /ID# 244338	Athens	Attiki
Greece	University General Hospital Attikon /ID# 248265	Athens	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 244337	Heraklion	Kriti
Greece	University General Hospital of Ioannina /ID# 244336	Ioannina
Greece	University General Hospital of Patras /ID# 244335	RION Patras Achaia
Greece	General Hospital of Thessaloniki George Papanikolaou /ID# 244237	Thessaloniki
Greece	Papageorgiou General Hospital /ID# 248266	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Achieving Composite Complete Remission	Composite complete remission is defined as the proportion of participants with complete remission (CR) or complete remission with incomplete marrow recovery (CRi).	Up to 30 Months
Secondary	Total Time of Treatment with Venetoclax Combination Therapy	The total time of treatment with venetoclax combination therapy.	Up to 30 Months
Secondary	Time to Transfusion Independence	Total duration of transfusion independence is defined as the period of at least 56 days with no Red Blood Cell (RBC) or platelet transfusion between the first dose of study drug and the last dose of study drug plus 30 days.	Up to 30 Months
Secondary	Post Baseline RBC and Platelet Transfusion Independence Rate	Post baseline RBC and platelet transfusion independence rate will be calculated as the proportion of participants who achieved RBC and platelet, respectively, transfusion independence post baseline.	Up to 30 Months
Secondary	Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important	The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.	Up to 30 Months
Secondary	Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs)	Treatment patterns defined by the proportion of participants treated with venetoclax in combination with HMAs (dosing with venetoclax and any modifications/interruptions/titrations, type and dosing of each HMA, frequency of response assessment, cycle length, dosing, concomitant medications, etc).	Up to 30 Months
Secondary	Healthcare Resource Utilization as the Number of Transfusions (Red Blood Cell [RBC] or Platelets) Received during First-line Treatment in an Outpatient Setting	Healthcare resource utilization as the number of transfusions (red blood cell [RBC] or platelets) received during first-line treatment in an outpatient setting.	Up to 30 Months
Secondary	Healthcare Resource Utilization as the Number of Hospitalizations during First-line Treatment	Healthcare resource utilization as the number of hospitalizations during first-line treatment.	Up to 30 Months
Secondary	Healthcare Resource Utilization as the Number of Intensive Care Unit (ICU) Admissions during First-line Treatment	Healthcare resource utilization as the number of intensive care unit (ICU) admissions during first-line treatment.	Up to 30 Months
Secondary	Healthcare Resource Utilization as the Number of Visits in a Private Healthcare Practitioner	Healthcare resource utilization as the number of visits in a private healthcare practitioner.	Up to 30 Months
Secondary	Healthcare Resource Utilization as the Name of Relevant Medication due to Infections (Antibiotics or Other)	Healthcare resource utilization as the name of relevant medication due to infections (antibiotics or other).	Up to 30 Months
Secondary	Healthcare Resource Utilization as the Dosing Scheme of Relevant Medication due to Infections (Antibiotics or Other)	Healthcare resource utilization as the dosing scheme of relevant medication due to infections (antibiotics or other).	Up to 30 Months
Secondary	Healthcare Resource Utilization as the Number of Laboratory Tests	Healthcare resource utilization as the number of laboratory tests.	Up to 30 Months
Secondary	Healthcare Resource Utilization as the Type of Laboratory Tests	Healthcare resource utilization as the type of laboratory tests.	Up to 30 Months

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