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NCT Number: 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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Capturing Canadian Real-World Data for AML Chemotherapy Ineligible Patients on Venetoclax (LIVEN)

Acronym: LIVEN

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 21, 2022
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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