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 (SURVIVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Greece
  • Alexandroupolis, Greece, 68100
    • Active, not recruiting
    • General University Hospital of Alexandroupolis /ID# 244235
  • Athens, Greece, 10676
    • Active, not recruiting
    • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 244339
  • Athens, Greece, 11522
    • Active, not recruiting
    • General Anti-cancer Hospital Agios Savvas /ID# 244408
  • Athens, Greece, 11527
    • Active, not recruiting
    • General Hospital of Athens Laiko - Hematology Location /ID# 244234
  • Ioannina, Greece, 45500
    • Active, not recruiting
    • University General Hospital of Ioannina /ID# 244336
  • RION Patras Achaia, Greece, 26504
    • Active, not recruiting
    • University General Hospital of Patras /ID# 244335
  • Thessaloniki, Greece, 56429
    • Recruiting
    • Papageorgiou General Hospital /ID# 248266
  • Thessaloniki, Greece, 57010
    • Active, not recruiting
    • General Hospital of Thessaloniki George Papanikolaou /ID# 244237
  • Attiki
    • Athens, Attiki, Greece, 11527
      • Active, not recruiting
      • General Hospital of Athens Gennimatas /ID# 245968
    • Athens, Attiki, Greece, 11527
      • Active, not recruiting
      • General Hospital of Athens Laiko /ID# 244338
    • Athens, Attiki, Greece, 12462
      • Active, not recruiting
      • University General Hospital Attikon /ID# 248265
  • Kriti
    • Heraklion, Kriti, Greece, 71500
      • Recruiting
      • University General Hospital of Heraklion PA.G.N.I /ID# 244337

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Venetoclax Participants; Participants treated with Venetoclax in accordance with approved local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Total Time of Treatment with Venetoclax Combination Therapy	The total time of treatment with venetoclax combination therapy.	Up to 30 Months
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
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
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
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
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
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
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
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
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
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
Healthcare Resource Utilization as the Number of Laboratory Tests	Healthcare resource utilization as the number of laboratory tests.	Up to 30 Months
Healthcare Resource Utilization as the Type of Laboratory Tests	Healthcare resource utilization as the type of laboratory tests.	Up to 30 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Acute Myeloid Leukemia; Venetoclax; ABT-199; Venclexta; Venclyxto
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: P22-535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No