NCT06621199

Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

A Prospective, Single-arm, Multi-center, Phase 2 Clinical Study of Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 60 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).

Detailed description

The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Mitoxantrone hydrochloride liposome (Lipo-MIT) is an innovative anthracycline nano-drug, which has been demonstrated favorable pharmacokinetic characteristics, high cardiac safety, and shown preliminary efficacy in adult AML. Thus, we designed a prospective, single-arm, phase 2 trial to explore the efficacy and safety of Lipo-MIT in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. The induction therapy is a combination of Lipo-MIT (24 mg/m\^2, day 1), cytarabine(100mg/m\^2, day 1-5) and venetoclax (200mg day 2, 300mg day 3, 400mg day 4-10,), and would be applied for two cycles. Patients who achieve CR/CRi after using MAV induction regimen will receive the consolidation therapy according to the patients' cytogenetic-molecular risk stratification and maintenance therapy. After completion of the treatment phase, patients entered the follow-up period.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Mitoxantrone hydrochloride liposome	Mitoxantrone hydrochloride liposome 24 mg/m\^2 on day 1, every 4 weeks
DRUG	Cytarabine	Cytarabine 100 mg/m\^2 on day 1-5, 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

Timeline

• Start date: 2024-07-08
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

1 site across 1 country: China