NCT05345938

A Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia

A Phase I/II Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label, single-arm, phase I/II study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of mitoxantrone hydrochloride liposome injection in subjects with acute myeloid leukemia (AML).

Detailed description

This study will have two stages. Stage 1: Dose escalation, about 9-18 subjects, who are either refractory to induction therapy or have relapsed (R/R) after achieving remission with prior therapy will be recruited. The enrolled subjects will receive Mitoxantrone Hydrochloride Liposome injection in one of three dose-escalation (30 mg/m\^2, 36 mg/m\^2, 40 mg/m\^2) by intravenous infusion (IV), every 28 days (q4w, 1 cycle). If the patient achieves remission (at least PR) after at most 2 cycles of induction, the original regimen of consolidation therapy can be continued for 2-4 cycles, with a total course of no more than 6 cycles. The DLT observation period is 28 days after the first dose in cycle 1, and including the first 28 days treatment cycle. Subjects in Cycle 1 will have PK sampling performed. Stage 2: Dose expansion, about 35-72 subjects with R/R AML or unfit AML will be recruited. The subjects will receive Mitoxantrone Hydrochloride Liposome dose according to the results of stage 1. If the patient achieves remission (at least PR) after at most 2 cycles of induction, the original regimen of consolidation therapy can be continued for 2-4 cycles, with a total course of no more than 6 cycles.

Conditions

• Relapsed or Refractory Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome	Intravenous injection (IV), on day 1 of each 28-day cycle (q4w)

Timeline

• Start date: 2022-06-14
• Primary completion: 2022-11-19
• Completion: 2022-11-19
• First posted: 2022-04-26
• Last updated: 2024-02-23

Locations

1 site across 1 country: China