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

Acute Myeloid Leukemia Clinical Trial

— LIVEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424562
• Other study ID #: P23-363
• Status: Recruiting
• Start date: September 7, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: June 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 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 200 participants will be enrolled in the study in approximately 15-20 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre /ID# 248113	Calgary	Alberta
Canada	University of Alberta Hospital /ID# 251531	Edmonton	Alberta
Canada	QEII - Health Sciences Centre /ID# 246514	Halifax	Nova Scotia
Canada	Juravinski Cancer Centre /ID# 247183	Hamilton	Ontario
Canada	Kingston Health Sciences Centre /ID# 253439	Kingston	Ontario
Canada	London Health Sciences Center- University Hospital /ID# 248027	London	Ontario
Canada	The Moncton Hospital /ID# 247277	Moncton	New Brunswick
Canada	Royal Victoria Hospital / McGill University Health Centre /ID# 249704	Montreal	Quebec
Canada	Lakeridge Health - Oshawa /ID# 246412	Oshawa	Ontario
Canada	Allan Blair Cancer Centre /ID# 247663	Regina	Saskatchewan
Canada	Saskatoon Cancer Centre /ID# 247181	Saskatoon	Saskatchewan
Canada	CIUSSS de l'Estrie - CHUS /ID# 248915	Sherbrooke	Quebec
Canada	Eastern Regional Health Authority /ID# 250241	St. John's	Newfoundland and Labrador
Canada	BC Cancer - Surrey /ID# 257515	Surrey	British Columbia
Canada	Thunder Bay Regional Research Institute /ID# 249163	Thunder Bay	Ontario
Canada	Princess Margaret Cancer Centre /ID# 249607	Toronto	Ontario
Canada	Sunnybrook Health Sciences Ctr /ID# 251966	Toronto	Ontario
Canada	Vancouver General Hospital /ID# 245438	Vancouver	British Columbia
Canada	BC Cancer - Victoria /ID# 257339	Victoria	British Columbia
Canada	CancerCare Manitoba /ID# 246414	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of Participants with Transfusions	Number of Participants with transfusions (red blood cells and platelets).	Up to 36 Months
Secondary	Number of Participants with Change in Venetoclax Dose	Number of participants with change in venetoclax dose.	Up to 36 Months
Secondary	Number of Participants with Change in Other Medications	Number of participants with change in other medications.	Up to 36 Months
Secondary	Venetoclax Administration Setting	Venetoclax administration setting (in-patient vs. out-patient vs. at home).	Up to 36 Months
Secondary	Number of Hospital Admission	Number of hospital admission.	Up to 36 Months
Secondary	Number of Participants with Change in use of Antiinfectives	Number of participants with change in use of antiinfectives.	Up to 36 Months
Secondary	Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk	Number of participants with change in TLS risk.	Up to 36 Months
Secondary	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

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