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Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML
Sponsor: First Affiliated Hospital of Zhejiang University
Summary
This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).
Official title: A Prospective, Single-arm, Multi-center, Phase 2 Clinical Study of Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML
Key Details
Gender
All
Age Range
60 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2024-07-08
Completion Date
2027-12-31
Last Updated
2024-10-01
Healthy Volunteers
No
Conditions
Interventions
Mitoxantrone hydrochloride liposome
Mitoxantrone hydrochloride liposome 24 mg/m\^2 on day 1, every 4 weeks
Cytarabine
Cytarabine 100 mg/m\^2 on day 1-5, every 4 weeks
Venetoclax
Venetoclax 100 mg on day 2,200 mg on day 3,400 mg on day 4-10, every 4 weeks
Locations (1)
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China