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

Last updated: June 11, 2024
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Myeloid Leukemia

Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT05424562
P23-363
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Diagnosis of Acute Myeloid Leukemia (AML).

  • Ineligible for intensive chemotherapy, determined by the physician's assessment ofage, 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 inaccordance with the local label. The decision to treat with venetoclax is made bythe physician prior to any decision to approach the participant to participate inthis study.

Exclusion

Exclusion Criteria:

  • Participation in an interventional clinical trial within 30 days prior to venetoclaxtreatment initiation.

Study Design

Total Participants: 270
Study Start date:
September 07, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Tom Baker Cancer Centre /ID# 248113

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • University of Alberta Hospital - Division of Hematology /ID# 251531

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • University of Alberta Hospital /ID# 251531

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

  • BC Cancer - Surrey /ID# 257515

    Surrey, British Columbia V3V 1Z2
    Canada

    Active - Recruiting

  • Vancouver General Hospital /ID# 245438

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • BC Cancer - Victoria /ID# 257339

    Victoria, British Columbia V8R 6V5
    Canada

    Active - Recruiting

  • CancerCare Manitoba /ID# 246414

    Winnipeg, Manitoba R3E 0V9
    Canada

    Active - Recruiting

  • The Moncton Hospital /ID# 247277

    Moncton, New Brunswick E1C 6Z8
    Canada

    Active - Recruiting

  • Eastern Regional Health Authority /ID# 250241

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

    Active - Recruiting

  • QEII - Health Sciences Centre /ID# 246514

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Juravinski Cancer Centre /ID# 247183

    Hamilton, Ontario L8V 1C3
    Canada

    Active - Recruiting

  • Kingston Health Sciences Centre /ID# 253439

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • London Health Sciences Center /ID# 248027

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • London Health Sciences Center- University Hospital /ID# 248027

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Lakeridge Health - Oshawa /ID# 246412

    Oshawa, Ontario L1G 2B9
    Canada

    Active - Recruiting

  • Thunder Bay Regional Research Institute /ID# 249163

    Thunder Bay, Ontario P7B 6V4
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre /ID# 249607

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Ctr /ID# 251966

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 253539

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Royal Victoria Hospital / McGill University Health Centre /ID# 249704

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • CHUQ- Hôpital de l'Enfant-Jesus /ID# 247278

    Quebec City, Quebec G1J 1Z4
    Canada

    Site Not Available

  • CIUSSS de l'Estrie - CHUS /ID# 248915

    Sherbrooke, Quebec J1G 2E8
    Canada

    Active - Recruiting

  • Allan Blair Cancer Centre /ID# 247663

    Regina, Saskatchewan S4T 7T1
    Canada

    Active - Recruiting

  • Saskatoon Cancer Centre /ID# 247181

    Saskatoon, Saskatchewan S7N 4H4
    Canada

    Active - Recruiting

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