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

NCT05424562 | Active Not Recruiting

• 1 other identifier: P23-363
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 20

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Venetoclax; Venclexta; Venclyxto; ABT-199; Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS as defined by number of days from start of treatment to the completion of treatment or death from any cause.

  Up to 36 Months

Secondary Outcomes (11)

• Change in Composite Complete Remission Rate

  Up to 36 Months

• Event-Free Survival (EFS)

  Up to 36 Months

• Percentage of Participants with Presence Transfusion Independence

  Up to 36 Months

• Number of Participants with Transfusions

  Up to 36 Months

• Number of Participants with Change in Venetoclax Dose

  Up to 36 Months

Study Arms (1)

Venetoclax Participants

Participants treated with Venetoclax in accordance with approved local label.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with acute myeloid leukemia (AML) treated with venetoclax per approved local label in Canada.

You may qualify if:

• 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.

You may not qualify if:

• \- Participation in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (20)

Tom Baker Cancer Centre /ID# 248113

Calgary, Alberta, T2N 4N2, Canada

Location

University of Alberta Hospital /ID# 251531

Edmonton, Alberta, T6G 2B7, Canada

Location

BC Cancer - Surrey /ID# 257515

Surrey, British Columbia, V3V 1Z2, Canada

Location

Vancouver General Hospital /ID# 245438

Vancouver, British Columbia, V5Z 1M9, Canada

Location

BC Cancer - Victoria /ID# 257339

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba /ID# 246414

Winnipeg, Manitoba, R3E 0V9, Canada

Location

The Moncton Hospital /ID# 247277

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Eastern Regional Health Authority /ID# 250241

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 246514

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Juravinski Cancer Centre /ID# 247183

Hamilton, Ontario, L8V 1C3, Canada

Location

Kingston Health Sciences Centre /ID# 253439

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Center- University Hospital /ID# 248027

London, Ontario, N6A 5W9, Canada

Location

Lakeridge Health - Oshawa /ID# 246412

Oshawa, Ontario, L1G 2B9, Canada

Location

Thunder Bay Regional Research Institute /ID# 249163

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Sunnybrook Health Sciences Centre /ID# 251966

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network_Princess Margaret Cancer Centre /ID# 249607

Toronto, Ontario, M5G 2M9, Canada

Location

Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 249704

Montreal, Quebec, H4A 3J1, Canada

Location

CIUSSS de l'Estrie - CHUS /ID# 248915

Sherbrooke, Quebec, J1G 2E8, Canada

Location

Allan Blair Cancer Centre /ID# 247663

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre /ID# 247181

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Links

• Related Info.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: September 7, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CA (20)