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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 (LIVEN)

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ClinicalTrials.gov Identifier: NCT05424562
Recruitment Status : Recruiting
First Posted : June 21, 2022
Last Update Posted : September 15, 2022
Sponsor:
Information provided by (Responsible Party):
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 270 participants will be enrolled in the study in approximately 15 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.


Condition or disease
Acute Myeloid Leukemia

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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Capturing Canadian Real-World Data for AML Chemotherapy Ineligible Patients on Venetoclax (LIVEN)
Actual Study Start Date : September 7, 2022
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026


Group/Cohort
Venetoclax Participants
Participants treated with Venetoclax in accordance with approved local label.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Composite Complete Remission Rate [ Time Frame: 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.

  2. Event-Free Survival (EFS) [ Time Frame: 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.

  3. Percentage of Participants with Presence Transfusion Independence [ Time Frame: 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.

  4. Number of Participants with Transfusions [ Time Frame: Up to 36 Months ]
    Number of Participants with transfusions (red blood cells and platelets).

  5. Number of Participants with Change in Venetoclax Dose [ Time Frame: Up to 36 Months ]
    Number of participants with change in venetoclax dose.

  6. Number of Participants with Change in Other Medications [ Time Frame: Up to 36 Months ]
    Number of participants with change in other medications.

  7. Venetoclax Administration Setting [ Time Frame: Up to 36 Months ]
    Venetoclax administration setting (in-patient vs. out-patient vs. at home).

  8. Number of Hospital Admission [ Time Frame: Up to 36 Months ]
    Number of hospital admission.

  9. Number of Participants with Change in use of Antiinfectives [ Time Frame: Up to 36 Months ]
    Number of participants with change in use of antiinfectives.

  10. Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk [ Time Frame: Up to 36 Months ]
    Number of participants with change in TLS risk.

  11. Occurrence of any Adverse Events [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Canada.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05424562


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Canada, Alberta
Tom Baker Cancer Centre /ID# 248113 Not yet recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Vancouver General Hospital /ID# 245438 Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
CancerCare Manitoba /ID# 246414 Not yet recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
The Moncton Hospital /ID# 247277 Not yet recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Newfoundland and Labrador
Eastern Regional Health Authority /ID# 250241 Not yet recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
QEII - Health Sciences Centre /ID# 246514 Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Juravinski Cancer Centre /ID# 247183 Not yet recruiting
Hamilton, Ontario, Canada, L8V 1C3
London Health Sciences Center /ID# 248027 Not yet recruiting
London, Ontario, Canada, N6A 5W9
Lakeridge Health - Oshawa /ID# 246412 Not yet recruiting
Oshawa, Ontario, Canada, L1G 2B9
Princess Margaret Cancer Centre /ID# 249607 Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Royal Victoria Hospital / McGill University Health Centre /ID# 249704 Not yet recruiting
Montreal, Quebec, Canada, H4A 3J1
CIUSSS de l'Estrie - CHUS /ID# 248915 Not yet recruiting
Sherbrooke, Quebec, Canada, J1G 2E8
Canada, Saskatchewan
Allan Blair Cancer Centre /ID# 247663 Not yet recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre /ID# 247181 Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05424562    
Other Study ID Numbers: P23-363
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Acute Myeloid Leukemia
Venetoclax
Venclexta
Venclyxto
ABT-199
Cancer
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms