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RECRUITING
NCT06621199
PHASE2

Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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

Interventions

DRUG

Mitoxantrone hydrochloride liposome

Mitoxantrone hydrochloride liposome 24 mg/m\^2 on day 1, every 4 weeks

DRUG

Cytarabine

Cytarabine 100 mg/m\^2 on day 1-5, every 4 weeks

DRUG

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