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
NCT ID: NCT05424562
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
210 participants
OBSERVATIONAL
2022-09-07
2027-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Venetoclax Participants
Participants treated with Venetoclax in accordance with approved local label.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Tom Baker Cancer Centre /ID# 248113
Calgary, Alberta, Canada
University of Alberta Hospital /ID# 251531
Edmonton, Alberta, Canada
BC Cancer - Surrey /ID# 257515
Surrey, British Columbia, 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, Canada
The Moncton Hospital /ID# 247277
Moncton, New Brunswick, Canada
Eastern Regional Health Authority /ID# 250241
St. John's, Newfoundland and Labrador, Canada
Queen Elizabeth II Health Sciences Centre - Victoria General /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
Lakeridge Health - Oshawa /ID# 246412
Oshawa, Ontario, Canada
Thunder Bay Regional Research Institute /ID# 249163
Thunder Bay, Ontario, Canada
Sunnybrook Health Sciences Centre /ID# 251966
Toronto, Ontario, Canada
University Health Network_Princess Margaret Cancer Centre /ID# 249607
Toronto, Ontario, Canada
Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 249704
Montreal, Quebec, Canada
CIUSSS de l'Estrie - CHUS /ID# 248915
Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre /ID# 247663
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre /ID# 247181
Saskatoon, Saskatchewan, Canada
Countries
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Related Links
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Related Info.
Other Identifiers
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P23-363
Identifier Type: -
Identifier Source: org_study_id
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