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Mitoxantrone Hydrochloride Liposome Combined With Chemotherapy in Untreated de Novo Acute Myeloid Leukemia

NCT05941585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-03

No results posted yet for this study

Summary

The purpose of this study is to determine the safety, efficacy and pharmacokinetics of mitoxantrone hydrochloride liposome injection combined with chemotherapy in previously untreated de novo acute myeloid leukemia.

Conditions

Interventions

DRUG

Mitoxantrone hydrochloride liposome injection30mg/m2

Mitoxantrone hydrochloride liposome intravenous infusion on day 1 (30mg/m2)

DRUG

HomoharringtonineD1-D7(2mg/m2/day)

Homoharringtonine intravenous infusion on D1-D7,2mg/m2/day in a 4-week treatment cycle.

DRUG

Venetoclax (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day)

Venetoclax d4-d12 (d4 100mg/day, d5200mg/day ,d6-d12 400mg/day)in a 4-week treatment cycle.

DRUG

Cytarabine(standard-dose:d1-d7100mg/m2/day)

Cytarabine intravenous infusion on d1-d7 ,100mg/m2/day

DRUG

Cytarabine(intermediate-dose:d1-d4100mg/m2/day, d5-d7 1g/m2)

d1-d4100mg/m2/day, d5-d7 1g/m2

DRUG

Mitoxantrone hydrochloride liposome injection24mg/m2

Mitoxantrone hydrochloride liposome intravenous infusion on day 1 (24mg/m2)

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • wang jianxiang, MD · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-08
Primary Completion
2025-01-17
Completion
2025-01-17

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05941585 on ClinicalTrials.gov