NCT05941585

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

A Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection Combined With Chemotherapy in Previously Untreated de Novo Acute Myeloid Leukemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multi-center, randomized, open-label, three-arm clinical study to explore the efficacy among three chemotherapy regimens combined with mitoxantrone hydrochloride liposome in previously untreated de novo acute myeloid leukemia. Patients will be randomized to different treatment group and be given different induction therapy in the first cycle. If patients do not achieve Morphologic Leukemia-free State (MLFS) after the first induction cycle, they will receive the second induction therapy with mitoxantrone hydrochloride liposome, cytarabine and venetoclax. Mitoxantrone hydrochloride liposome will be given on day 1 at the dose of 24 mg/m2 or 30 mg/m2 and be combined with cytarabine, venetoclax or homoharringtonine. A maximum of 2 cycles of induction therapy are planned.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-08-08
• Primary completion: 2025-01-17
• Completion: 2025-01-17
• First posted: 2023-07-12
• Last updated: 2025-06-03

Locations

1 site across 1 country: China