A Study of the Effectiveness of Venetoclax Tablets in Adult Acute Myeloid Leukemia Participants Ineligible for Standard Induction Therapy in Russian Federation

  • STATUS
    Recruiting
  • participants needed
    50
  • sponsor
    AbbVie
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Updated on 19 February 2024
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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 standard induction therapy in Russian Federation.

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 diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation.

Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.

Details
Condition Acute myeloid leukemia, Acute myeloid leukemia
Age 18years - 100years
Clinical Study IdentifierNCT04253314
SponsorAbbVie
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Newly diagnosed acute myeloid leukemia (AML) (de novo or secondary) and eligible to receive Venetoclax as per Russian Ministry of Health label
Ineligible for standard induction therapy with cytarabine and anthracycline
Eastern Cooperative Oncology Group (ECOG) score >2
White blood cell counts <25 x 109 per liter
Started Venetoclax within 4 weeks of enrolling in study

Exclusion Criteria

Acute promyelocytic leukemia
Contraindications to Venetoclax as listed on the approved local label in Russian Federation
Neuroleukemia - active central nervous system (CNS) involvement
Participation in a clinical trial with an investigational drug for AML within 30 days prior to Venetoclax treatment initiation
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