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A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy in Switzerland and Austria Receiving Oral Venetoclax Tablets (VALOR)

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AbbVie

Status

Completed

Conditions

Acute Myeloid Leukemia

Study type

Observational

Funder types

Industry

Identifiers

NCT05215639
P21-937

Details and patient eligibility

About

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 chemotherapy in Switzerland & Austria.

Venetoclax is a drug approved to treat acute myeloid leukemia. 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 chemotherapy will be enrolled. Around 120 participants will be enrolled in the study in approximately 15 sites in Switzerland & Austria.

Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 24 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 24 months.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Newly-diagnosed AML and eligible to receive venetoclax as per local label.
  • Physician has decided to initiate venetoclax treatment. The decision to treat with venetoclax is made by the physician in accordance with the local label prior to any decision to approach the patient to participate in this study.

Exclusion criteria

- Participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Trial design

120 participants in 1 patient group

Venetoclax Participants
Description:
Participants treated with Venetoclax in accordance with approved local label.

Trial contacts and locations

19

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Central trial contact

ABBVIE CALL CENTER

Data sourced from clinicaltrials.gov

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