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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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 ID: NCT05424562

Interventions

Study Description

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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Tom Baker Cancer Centre /ID# 248113, Calgary, Alberta, Canada

University of Alberta Hospital /ID# 251531, Edmonton, Alberta, Canada

BC Cancer - Surrey /ID# 257515, Surrey, British Columbia, Canada

Vancouver General Hospital /ID# 245438, Vancouver, British Columbia, Canada

BC Cancer - Victoria /ID# 257339, Victoria, British Columbia, Canada

CancerCare Manitoba /ID# 246414, Winnipeg, Manitoba, Canada

The Moncton Hospital /ID# 247277, Moncton, New Brunswick, Canada

Eastern Regional Health Authority /ID# 250241, St. John's, Newfoundland and Labrador, 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

Lakeridge Health - Oshawa /ID# 246412, Oshawa, Ontario, Canada

Thunder Bay Regional Research Institute /ID# 249163, Thunder Bay, 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

CIUSSS de l'Estrie - CHUS /ID# 248915, Sherbrooke, Quebec, Canada

Allan Blair Cancer Centre /ID# 247663, Regina, Saskatchewan, Canada

Saskatoon Cancer Centre /ID# 247181, Saskatoon, Saskatchewan, Canada

Contact Details

Name: ABBVIE INC.

Affiliation: AbbVie

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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