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 Canada (LIVEN)

Capturing Canadian Real-World Data for AML Chemotherapy Ineligible Patients on Venetoclax (LIVEN)

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 induction chemotherapy in Canada.

Venetoclax is a drug approved to treat Acute Myeloid Leukemia (AML). 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 induction chemotherapy will be enrolled. Around 270 participants will be enrolled in the study in approximately 15 sites in Canada.

Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 36 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 36 months.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia

• Study Type: Observational
• Enrollment (Estimated): 270

Contacts and Locations

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

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Recruiting
      • Tom Baker Cancer Centre /ID# 248113
    • Edmonton, Alberta, Canada, T6G 2B7
      • Recruiting
      • University of Alberta Hospital /ID# 251531
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • Recruiting
      • BC Cancer - Surrey /ID# 257515
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • Vancouver General Hospital /ID# 245438
    • Victoria, British Columbia, Canada, V8R 6V5
      • Recruiting
      • BC Cancer - Victoria /ID# 257339
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Recruiting
      • CancerCare Manitoba /ID# 246414
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Recruiting
      • The Moncton Hospital /ID# 247277
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Recruiting
      • Eastern Regional Health Authority /ID# 250241
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Recruiting
      • QEII - Health Sciences Centre /ID# 246514
  • Ontario
    • Hamilton, Ontario, Canada, L8V 1C3
      • Recruiting
      • Juravinski Cancer Centre /ID# 247183
      • Contact: Site Coordinator; Phone Number: 9055212100
    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
      • Kingston Health Sciences Centre /ID# 253439
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Center- University Hospital /ID# 248027
    • Oshawa, Ontario, Canada, L1G 2B9
      • Recruiting
      • Lakeridge Health - Oshawa /ID# 246412
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Recruiting
      • Thunder Bay Regional Research Institute /ID# 249163
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Ctr /ID# 251966
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre /ID# 249607
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Royal Victoria Hospital / McGill University Health Centre /ID# 249704
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • Recruiting
      • CIUSSS de l'Estrie - CHUS /ID# 248915
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Recruiting
      • Allan Blair Cancer Centre /ID# 247663
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Recruiting
      • Saskatoon Cancer Centre /ID# 247181

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 Canada.

Description

Inclusion Criteria:

• Diagnosis of Acute Myeloid Leukemia (AML).
• Ineligible for intensive chemotherapy, determined by the physician's assessment of age, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), comorbidities, regional guidelines, and institutional practice.
• Participant for whom the physician has decided to initiate venetoclax treatment in accordance with the local label. The decision to treat with venetoclax is made by the physician prior to any decision to approach the participant to participate in this study.

Exclusion Criteria:

- Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Study Plan

How is the study designed?

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
Overall Survival (OS)	OS as defined by number of days from start of treatment to the completion of treatment or death from any cause.	Up to 36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Composite Complete Remission Rate	Composite Complete Remission Rate is defined as complete remission (CR) plus complete remission with incomplete hematologic recovery (CRi) as described by the modified International Working Group (IWG) criteria.	Up to 36 Months
Event-Free Survival (EFS)	EFS as defined by number of days from start of treatment to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause.	Up to 36 Months
Percentage of Participants with Presence Transfusion Independence	Transfusion Independence is defined as at least 8 and/or 16 consecutive weeks without an Red Blood Cell (RBC) or platelet transfusion during the treatment period.	Up to 36 Months
Number of Participants with Transfusions	Number of Participants with transfusions (red blood cells and platelets).	Up to 36 Months
Number of Participants with Change in Venetoclax Dose	Number of participants with change in venetoclax dose.	Up to 36 Months
Number of Participants with Change in Other Medications	Number of participants with change in other medications.	Up to 36 Months
Venetoclax Administration Setting	Venetoclax administration setting (in-patient vs. out-patient vs. at home).	Up to 36 Months
Number of Hospital Admission	Number of hospital admission.	Up to 36 Months
Number of Participants with Change in use of Antiinfectives	Number of participants with change in use of antiinfectives.	Up to 36 Months
Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk	Number of participants with change in TLS risk.	Up to 36 Months
Occurrence of any Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment as graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).	Up to 36 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): September 7, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 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: P23-363

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