SURVIVE: 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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05317494

Collaborator

(none)

100

Enrollment

Locations

55.2

Anticipated Duration (Months)

9.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

May 26, 2022

Anticipated Primary Completion Date :

May 30, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Venetoclax Participants Participants treated with Venetoclax in accordance with approved local label.

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Overall Survival (OS) [Up to 30 Months]
OS is defined as the time from treatment initiation to death from any cause.

Secondary Outcome Measures

Percentage of Participants Achieving Composite Complete Remission [Up to 30 Months]
Composite complete remission is defined as the proportion of participants with complete remission (CR) or complete remission with incomplete marrow recovery (CRi).
Total Time of Treatment with Venetoclax Combination Therapy [Up to 30 Months]
The total time of treatment with venetoclax combination therapy.
Time to Transfusion Independence [Up to 30 Months]
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.
Post Baseline RBC and Platelet Transfusion Independence Rate [Up to 30 Months]
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.
Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Considered Minimally Clinical Important [Up to 30 Months]
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.
Treatment Patterns Venetoclax in Combination with Hypomethylating Agents (HMAs) [Up to 30 Months]
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).
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]
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 Hospitalizations during First-line Treatment [Up to 30 Months]
Healthcare resource utilization as the number of hospitalizations during first-line treatment.
Healthcare Resource Utilization as the Number of Intensive Care Unit (ICU) Admissions during First-line Treatment [Up to 30 Months]
Healthcare resource utilization as the number of intensive care unit (ICU) admissions during first-line treatment.
Healthcare Resource Utilization as the Number of Visits in a Private Healthcare Practitioner [Up to 30 Months]
Healthcare resource utilization as the number of visits in a private healthcare practitioner.
Healthcare Resource Utilization as the Name of Relevant Medication due to Infections (Antibiotics or Other) [Up to 30 Months]
Healthcare resource utilization as the name 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]
Healthcare resource utilization as the dosing scheme of relevant medication due to infections (antibiotics or other).
Healthcare Resource Utilization as the Number of Laboratory Tests [Up to 30 Months]
Healthcare resource utilization as the number of laboratory tests.
Healthcare Resource Utilization as the Type of Laboratory Tests [Up to 30 Months]
Healthcare resource utilization as the type of laboratory tests.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of Athens Gennimatas /ID# 245968	Athens	Attiki	Greece	11527
2	General Hospital of Athens Laiko /ID# 244338	Athens	Attiki	Greece	11527
3	University General Hospital Attikon /ID# 248265	Athens	Attiki	Greece	12462
4	University General Hospital of Heraklion PA.G.N.I /ID# 244337	Heraklion	Kriti	Greece	71500
5	General University Hospital of Alexandroupolis /ID# 244235	Alexandroupolis		Greece	68100
6	General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339	Athens		Greece	10676
7	General Anti-cancer Hospital Agios Savvas /ID# 244408	Athens		Greece	11522
8	General Hospital of Athens Laiko - Hematology Location /ID# 244234	Athens		Greece	11527
9	University General Hospital of Ioannina /ID# 244336	Ioannina		Greece	45500
10	University General Hospital of Patras /ID# 244335	RION Patras Achaia		Greece	26504
11	General Hospital of Thessaloniki George Papanikolaou /ID# 244237	Thessaloniki		Greece	57010