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

N/AActive Not RecruitingNCT05424562

AbbVie210 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

210

Conditions

Acute Myeloid Leukemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (20)

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

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

Halifax, Nova Scotia, Canada

Juravinski Cancer Centre /ID# 247183

Hamilton, Ontario, Canada

...and 10 more locations

Outcomes

Primary Outcomes

Overall Survival (OS)

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

Time frame: Up to 36 Months

Secondary Outcomes

Change in Composite Complete Remission Rate

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.

Time frame: Up to 36 Months

Event-Free Survival (EFS)

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.

Time frame: Up to 36 Months

Percentage of Participants with Presence Transfusion Independence

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.

Time frame: Up to 36 Months

Number of Participants with Transfusions

Number of Participants with transfusions (red blood cells and platelets).

Time frame: Up to 36 Months

Number of Participants with Change in Venetoclax Dose

Number of participants with change in venetoclax dose.

Time frame: Up to 36 Months

Number of Participants with Change in Other Medications

Number of participants with change in other medications.

Time frame: Up to 36 Months

Venetoclax Administration Setting

Venetoclax administration setting (in-patient vs. out-patient vs. at home).

Time frame: Up to 36 Months

Number of Hospital Admission

Number of hospital admission.

Time frame: Up to 36 Months

Number of Participants with Change in use of Antiinfectives

Number of participants with change in use of antiinfectives.

Time frame: Up to 36 Months

Number of Participants with Change in Tumor Lysis Syndrome (TLS) Risk

Number of participants with change in TLS risk.

Time frame: Up to 36 Months

Occurrence of any Adverse Events

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).

Time frame: Up to 36 Months