Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML
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
The First Affiliated Hospital of Soochow University
60 participants
Mar 1, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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.
On day 1, homoharringtonine 1 mg/m2 IV will be given, and will continue for 5 days.
On day 1, cytarabine 100 mg/m2 IV will be given, and will continue for 5 days.
Locations(1)
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NCT05805098