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
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT05424562
- Lead Sponsor
- AbbVie
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 270
- 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.
- Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 36 Months OS as defined by number of days from start of treatment to the completion of treatment or death from any cause.
- Secondary Outcome Measures
Name Time Method Number of Participants with Change in Venetoclax Dose Up to 36 Months Number of participants with change in venetoclax dose.
Number of Hospital Admission Up to 36 Months Number of hospital admission.
Number of Participants with Change in use of Antiinfectives Up to 36 Months Number of participants with change in use of antiinfectives.
Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk Up to 36 Months Number of participants with change in TLS risk.
Occurrence of any Adverse Events Up to 36 Months 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).
Change in Composite Complete Remission Rate Up to 36 Months 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.
Event-Free Survival (EFS) Up to 36 Months 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.
Number of Participants with Change in Other Medications Up to 36 Months Number of participants with change in other medications.
Venetoclax Administration Setting Up to 36 Months Venetoclax administration setting (in-patient vs. out-patient vs. at home).
Percentage of Participants with Presence Transfusion Independence Up to 36 Months 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.
Number of Participants with Transfusions Up to 36 Months Number of Participants with transfusions (red blood cells and platelets).
Trial Locations
- Locations (20)
BC Cancer - Victoria /ID# 257339
🇨🇦Victoria, British Columbia, Canada
BC Cancer - Surrey /ID# 257515
🇨🇦Surrey, British Columbia, Canada
Vancouver General Hospital /ID# 245438
🇨🇦Vancouver, British Columbia, Canada
The Moncton Hospital /ID# 247277
🇨🇦Moncton, New Brunswick, 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
Thunder Bay Regional Research Institute /ID# 249163
🇨🇦Thunder Bay, Ontario, Canada
Lakeridge Health - Oshawa /ID# 246412
🇨🇦Oshawa, Ontario, Canada
Sunnybrook Health Sciences Ctr /ID# 251966
🇨🇦Toronto, Ontario, Canada
Princess Margaret Cancer Centre /ID# 249607
🇨🇦Toronto, Ontario, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 249704
🇨🇦Montreal, Quebec, Canada
Saskatoon Cancer Centre /ID# 247181
🇨🇦Saskatoon, Saskatchewan, Canada
Allan Blair Cancer Centre /ID# 247663
🇨🇦Regina, Saskatchewan, Canada
CIUSSS de l'Estrie - CHUS /ID# 248915
🇨🇦Sherbrooke, Quebec, Canada
Tom Baker Cancer Centre /ID# 248113
🇨🇦Calgary, Alberta, Canada
University of Alberta Hospital /ID# 251531
🇨🇦Edmonton, Alberta, Canada
Eastern Regional Health Authority /ID# 250241
🇨🇦St. John's, Newfoundland and Labrador, Canada
CancerCare Manitoba /ID# 246414
🇨🇦Winnipeg, Manitoba, Canada