Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT05464433
Brief Summary:
This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy in combination with tislelizumab and mitoxantrone hydrochloride liposome combination treatment in patients with relapsed or refractory Extranodal Natural Killer/T Cell Lymphoma（NKTCL）
Detailed Description:
This is a prospective, open-label, single arm, multicenter clinical study to explore the maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride when combined with tislelizumab in patients with relapsed or refractory Extranodal Natural Killer/T Cell Lymphoma（NKTCL）. Liposomal mitoxantrone hydrochloride will be given on day 1 at two different doses (16 mg/m2, 20 mg/m2) and be combined with tislelizumab. The dose limited toxicity (DLT) will be evaluated after the first cycle of therapy. A maximum of 6 cycles of therapy are planned. An dose expansion study of mitoxanquinone hydrochloride liposome at recommended phaseII dose (RP2D) dose level combined with tirelizumab was conducted to explore the efficacy and safety tolerance of the combined regimen. After 6 cycles of induction therapy, if the outcome was assessed as complete remission (CR)/partial remission (PR)/Stable disease (SD), continued maintenance therapy with tirelizumab.
Study:
NCT05464433
Study Brief:
Protocol Section:
NCT05464433