Acute Myeloid LeukemiaLIVENNCT05424562
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
An observational study of Acute Myeloid Leukemia, run by AbbVie at 20 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- How many people
- 210 participants
- Where
- 20 sitesCanada
- Study dates
- 7 Sep 2022to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Canada.
Who may be able to join
- 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.
Who cannot join
- Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Canada20 sites
Tom Baker Cancer Centre /ID# 248113
Calgary, Alberta, T2N 4N2
University of Alberta Hospital /ID# 251531
Edmonton, Alberta, T6G 2B7
Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 246514
Halifax, Nova Scotia, B3H 2Y9
Juravinski Cancer Centre /ID# 247183
Hamilton, Ontario, L8V 1C3
Kingston Health Sciences Centre /ID# 253439
Kingston, Ontario, K7L 2V7
London Health Sciences Center- University Hospital /ID# 248027
London, Ontario, N6A 5W9
The Moncton Hospital /ID# 247277
Moncton, New Brunswick, E1C 6Z8
Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 249704
Montreal, Quebec, H4A 3J1
Lakeridge Health - Oshawa /ID# 246412
Oshawa, Ontario, L1G 2B9
Allan Blair Cancer Centre /ID# 247663
Regina, Saskatchewan, S4T 7T1
Saskatoon Cancer Centre /ID# 247181
Saskatoon, Saskatchewan, S7N 4H4
CIUSSS de l'Estrie - CHUS /ID# 248915
Sherbrooke, Quebec, J1G 2E8
Eastern Regional Health Authority /ID# 250241
St. John's, Newfoundland and Labrador, A1B 3V6
BC Cancer - Surrey /ID# 257515
Surrey, British Columbia, V3V 1Z2
Thunder Bay Regional Research Institute /ID# 249163
Thunder Bay, Ontario, P7B 6V4
Sunnybrook Health Sciences Centre /ID# 251966
Toronto, Ontario, M4N 3M5
University Health Network_Princess Margaret Cancer Centre /ID# 249607
Toronto, Ontario, M5G 2M9
Vancouver General Hospital /ID# 245438
Vancouver, British Columbia, V5Z 1M9
BC Cancer - Victoria /ID# 257339
Victoria, British Columbia, V8R 6V5
CancerCare Manitoba /ID# 246414
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: 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 200 participants will be enrolled in the study in approximately 15-20 sites in Canada.
Read more
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.
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, ABT-199, Cancer
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax Participants | Participants treated with Venetoclax in accordance with approved local label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS as defined by number of days from start of treatment to the completion of treatment or death from any cause.
Measured: Up to 36 Months
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: Up to 36 Months
Number of Participants with Transfusions
Number of Participants with transfusions (red blood cells and platelets).
Measured: Up to 36 Months
Number of Participants with Change in Venetoclax Dose
Number of participants with change in venetoclax dose.
Measured: Up to 36 Months
Number of Participants with Change in Other Medications
Number of participants with change in other medications.
Measured: Up to 36 Months
Venetoclax Administration Setting
Venetoclax administration setting (in-patient vs. out-patient vs. at home).
Measured: Up to 36 Months
Number of Hospital Admission
Number of hospital admission.
Measured: Up to 36 Months
Number of Participants with Change in use of Antiinfectives
Number of participants with change in use of antiinfectives.
Measured: Up to 36 Months
Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk
Number of participants with change in TLS risk.
Measured: 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).
Measured: Up to 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start7 Sep 2022
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Why it stopped: Strategic Considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424562
- Sponsor's protocol ID
- P23-363
- Acronym
- LIVEN
- Status last verified
- Nov 2025
- First submitted
- 15 Jun 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capturing Canadian Real-World Data for AML Chemotherapy Ineligible Patients on Venetoclax (LIVEN)
- ClinicalTrials.gov ID
- NCT05424562
- Acronym / sponsor ID
- LIVEN / P23-363
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Venetoclax, Venclexta, Venclyxto, ABT-199, Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Strategic Considerations
- Enrolment
- 210 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax Participants | – | –Participants treated with Venetoclax in accordance with approved local label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Canada.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: 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.
11 secondary outcomes
Change in Composite Complete Remission Rate
Time frame: Up to 36 Months
Event-Free Survival (EFS)
Time frame: Up to 36 Months
Percentage of Participants with Presence Transfusion Independence
Time frame: Up to 36 Months
Number of Participants with Transfusions
Time frame: Up to 36 Months
Number of Participants with Change in Venetoclax Dose
Time frame: Up to 36 Months
Number of Participants with Change in Other Medications
Time frame: Up to 36 Months
Venetoclax Administration Setting
Time frame: Up to 36 Months
Number of Hospital Admission
Time frame: Up to 36 Months
Number of Participants with Change in use of Antiinfectives
Time frame: Up to 36 Months
Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk
Time frame: Up to 36 Months
Occurrence of any Adverse Events
Time frame: Up to 36 Months
Results and safety
The study was stopped early (reason given: Strategic Considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Related Info.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by AbbVie at 20 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Strategic Considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.