Assessing the effects of venetoclax in adults with acute myeloid leukemia who can't undergo intensive chemotherapy
Capturing Canadian Real-World Data for AML Chemotherapy Ineligible Patients on Venetoclax (LIVEN)
This study is testing if an oral medication called venetoclax can help adults with acute myeloid leukemia who can't have intensive chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 20 sites (Calgary, Alberta and 19 other locations) |
| Trial ID | NCT05424562 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of venetoclax, an oral medication, in treating adult patients diagnosed with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Approximately 200 participants will be enrolled across 15-20 sites in Canada, where they will receive venetoclax as prescribed by their physicians. The study will monitor changes in disease state over a duration of about 36 months, with all visits occurring during routine clinical practice, ensuring minimal additional burden on participants.
Who should consider this trial
Good fit: Ideal candidates are adults with a new diagnosis of acute myeloid leukemia who are deemed ineligible for intensive chemotherapy based on physician assessment.
Not a fit: Patients who are eligible for intensive chemotherapy or those participating in other interventional clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with AML who cannot tolerate intensive chemotherapy.
How similar studies have performed: Other studies have shown promising results with venetoclax in treating AML, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Calgary, Alberta and 19 other locations
- Tom Baker Cancer Centre /ID# 248113 — Calgary, Alberta, Canada (Recruiting)
- University of Alberta Hospital /ID# 251531 — Edmonton, Alberta, Canada (Recruiting)
- BC Cancer - Surrey /ID# 257515 — Surrey, British Columbia, Canada (Recruiting)
- Vancouver General Hospital /ID# 245438 — Vancouver, British Columbia, Canada (Recruiting)
- BC Cancer - Victoria /ID# 257339 — Victoria, British Columbia, Canada (Recruiting)
- CancerCare Manitoba /ID# 246414 — Winnipeg, Manitoba, Canada (Recruiting)
- The Moncton Hospital /ID# 247277 — Moncton, New Brunswick, Canada (Recruiting)
- Eastern Regional Health Authority /ID# 250241 — St. John's, Newfoundland and Labrador, Canada (Recruiting)
- QEII - Health Sciences Centre /ID# 246514 — Halifax, Nova Scotia, Canada (Recruiting)
- Juravinski Cancer Centre /ID# 247183 — Hamilton, Ontario, Canada (Recruiting)
- Kingston Health Sciences Centre /ID# 253439 — Kingston, Ontario, Canada (Recruiting)
- London Health Sciences Center- University Hospital /ID# 248027 — London, Ontario, Canada (Recruiting)
- Lakeridge Health - Oshawa /ID# 246412 — Oshawa, Ontario, Canada (Recruiting)
- Thunder Bay Regional Research Institute /ID# 249163 — Thunder Bay, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Ctr /ID# 251966 — Toronto, Ontario, Canada (Recruiting)
- Princess Margaret Cancer Centre /ID# 249607 — Toronto, Ontario, Canada (Recruiting)
- Royal Victoria Hospital / McGill University Health Centre /ID# 249704 — Montreal, Quebec, Canada (Recruiting)
- CIUSSS de l'Estrie - CHUS /ID# 248915 — Sherbrooke, Quebec, Canada (Recruiting)
- Allan Blair Cancer Centre /ID# 247663 — Regina, Saskatchewan, Canada (Recruiting)
- Saskatoon Cancer Centre /ID# 247181 — Saskatoon, Saskatchewan, Canada (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.