LIVEN

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

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.

Observational study

Status:
Not yet recruiting
Conditions:
Acute Myeloid Leukemia
Enrollment:
270 patients
Protocol ID:
P23-363
Observational model:
Cohort
Time perspective:
Prospective

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

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.

All the cities where the clinical studies are located

Calgary - T2N 4N2
Vancouver - V5Z 1M9
Halifax - B3H 2Y9
Hamilton - L8V 1C3
Oshawa - L1G 2B9
Quebec City - G1J 1Z4
Quebec City - G1J 1Z4
Moncton - E1C 6Z8
Winnipeg - R3E 0V9

Alberta

British Columbia

Manitoba

New Brunswick

Nova Scotia

Quebec

Saskatchewan