NCT05941585View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 8, 2023

Primary Completion Date

January 17, 2025

Study Completion Date

January 17, 2025

Conditions
Acute Myeloid Leukemia
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)

Trial Locations (1)

300020

Institute of Hematology & Blood Diseases Hospital, Tianjin

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER