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

NCT06434662 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-05-30

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory Acute Myeloid Leukaemia
  • Myeloid Malignancy

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

Sponsors & Collaborators

  • CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

    collaborator INDUSTRY

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • Jie Jin, M.D. · Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06434662 on ClinicalTrials.gov