CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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).
Diffuse Large B-Cell Lymphoma
Mitoxantrone Hydrochloride Liposome Injection
Phase 2
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 104 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | 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) |
Actual Study Start Date : | July 10, 2023 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | September 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Mitoxantrone Hydrochloride Liposome Injection The eligible patients will receive mitoxantrone hydrochloride liposome injection (20 mg/m^2) once every 4 weeks for a maximum of 8 cycles. |
Drug: Mitoxantrone Hydrochloride Liposome Injection |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Affiliated Cancer Hospital of Shandong First Medical University
women, Shandong, China, 250117