Clinical trial NCT05424562: 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
Official title: Capturing Canadian Real-World Data for AML Chemotherapy Ineligible Patients on Venetoclax (LIVEN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Venetoclax
Venclexta
Venclyxto
ABT-199
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Canada.

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.


Eligibility 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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 36 Months
Secondary outcomes:
measure: Change in Composite Complete Remission Rate
timeFrame: Up to 36 Months
measure: Event-Free Survival (EFS)
timeFrame: Up to 36 Months
measure: Percentage of Participants with Presence Transfusion Independence
timeFrame: Up to 36 Months
measure: Number of Participants with Transfusions
timeFrame: Up to 36 Months
measure: Number of Participants with Change in Venetoclax Dose
timeFrame: Up to 36 Months
measure: Number of Participants with Change in Other Medications
timeFrame: Up to 36 Months
measure: Venetoclax Administration Setting
timeFrame: Up to 36 Months
measure: Number of Hospital Admission
timeFrame: Up to 36 Months
measure: Number of Participants with Change in use of Antiinfectives
timeFrame: Up to 36 Months
measure: Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk
timeFrame: Up to 36 Months
measure: Occurrence of any Adverse Events
timeFrame: Up to 36 Months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre /ID# 248113
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital /ID# 251531
state: Alberta
city: Surrey
country: Canada
facility: BC Cancer - Surrey /ID# 257515
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital /ID# 245438
state: British Columbia
city: Victoria
country: Canada
facility: BC Cancer - Victoria /ID# 257339
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba /ID# 246414
state: Manitoba
city: Moncton
country: Canada
facility: The Moncton Hospital /ID# 247277
state: New Brunswick
city: St. John's
country: Canada
facility: Eastern Regional Health Authority /ID# 250241
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QEII - Health Sciences Centre /ID# 246514
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre /ID# 247183
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre /ID# 253439
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center- University Hospital /ID# 248027
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health - Oshawa /ID# 246412
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Research Institute /ID# 249163
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Ctr /ID# 251966
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre /ID# 249607
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital / McGill University Health Centre /ID# 249704
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS /ID# 248915
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre /ID# 247663
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre /ID# 247181
state: Saskatchewan
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: