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RECRUITING
NCT06434662
PHASE2

Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy. The main questions it aims to answer are:Dose the combination regimen of MAV enhanced the composite complete remission in R/R AML? Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.

Official title: A Phase II Study of the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection, Cytarabine and Venetoclax in Patients With Relapsed/Refractory AML

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2024-02-29

Completion Date

2026-06

Last Updated

2024-05-30

Healthy Volunteers

No

Interventions

DRUG

mitoxantrone hydrochloride liposome

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

DRUG

Cytarabine

Cytarabine (1.0 g/m\^2, q12h ) on day 1,3,5, 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