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Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML
Sponsor: The First Affiliated Hospital of Soochow University
Summary
This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.
Official title: Venetoclax in Combination With Homoharringtonine and Cytarabine in Newly Diagnosed Subjects With Acute Myeloid Leukemia: a Phase 2/3, the Single-arm, Open-label, Monocentric Study
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-03-01
Completion Date
2028-03-01
Last Updated
2023-04-07
Healthy Volunteers
No
Conditions
Interventions
Venetoclax
Starting on day 1, venetoclax will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2 and 400 mg on day 3. The patient then continues to take the 400mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day.
Homoharringtonine
On day 1, homoharringtonine 1 mg/m2 IV will be given, and will continue for 5 days.
Cytarabine
On day 1, cytarabine 100 mg/m2 IV will be given, and will continue for 5 days.
Locations (1)
Qiu Huiying
Suzhou, Jiangsu, China