NCT05875428

Mitoxantrone Hydrochloride Liposome Injection in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

A Phase 2, Single-arm, Multicenter Trial to Evaluate the Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, single-arm, phase 2 study of mitoxantrone hydrochloride liposome injection in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Detailed description

This is a phase 2, single-arm, multicenter trial to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in patients with R/R DLBCL. The eligible patients will receive mitoxantrone hydrochloride liposome injection (20 mg/m\^2) once every 4 weeks for a maximum of 8 cycles. Patients will receive treatment until the completion of 8 cycles of treatment, disease progression, intolerable toxicity, death, loss to follow-up, withdrawal (patient's decision or investigator's decision), whichever comes first. All patients will have post-treatment follow-up for disease status until disease progression/recurrence, initiation of new antitumor therapy, or being lost to follow-up.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Mitoxantrone Hydrochloride Liposome Injection	Be given intravenously at 20 mg/m\^2 on days 1 of each treatment cycle.

Timeline

• Start date: 2023-07-10
• Primary completion: 2024-12-31
• Completion: 2025-09-30
• First posted: 2023-05-25
• Last updated: 2024-02-08

Locations

1 site across 1 country: China