NCT06621212

Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML

A Prospective, Multi-center, Phase 2 Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Standard-dose Cytarabine and Venetoclax in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this prospective, multi-center, single-arm, phase 2 study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, standard-dose of cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. The study plan to enroll 72 R/R AML patients who are expected to receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.

Detailed description

For patients with R/R AML, there is currently no established standard treatment. Previous research suggests that mitoxantrone could against venetoclax-resistant leukemia stem cells (LSCs) by modulating mitochondrial calcium levels. Based on the potentially synergistic killing effect of mitoxantrone and venetoclax, a phase 2 study is underway in R/R AML. Patients receive mitoxantrone hydrochloride liposome, moderate-dose of cytarabine (1.0 g/m\^2, IV, q12h, d1, 3, 5) and venetoclax (MAV) when they were enrolled. Here the investigator also conduct another phase 2 study of MAV regimen with standard-dose of cytarabine in relapsed or refractory (R/R) AML, aiming to evaluate the efficacy and safety of MAV regimen. All participants will receive MAV treatment including 30 mg/m\^2 mitoxantrone hydrochloride liposome on day 1, 100 mg/m\^2 cytarabine on days 1-7 and 400 mg venetoclax on days 2-8 with a dose escalation on days 2-4. Each cycle consists of 4 weeks. A maximum of 2 cycles of therapy are planned.

Conditions

• Relapsed/Refractory Acute Myeloid Leukaemia
• Myeloid Malignancy

Interventions

Type	Name	Description
DRUG	mitoxantrone hydrochloride liposome	Mitoxantrone hydrochloride liposome (30 mg/m\^2) on day 1, every 4 weeks
DRUG	Cytarabine	Cytarabine (100 mg/m\^2 ) on day 1-7, every 4 weeks
DRUG	Venetoclax	Venetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-8, every 4 weeks

Timeline

• Start date: 2024-07-05
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2024-10-01
• Last updated: 2025-09-16

Locations

1 site across 1 country: China