Neoplasms

Blood and Lymph Conditions

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Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Neoplasms by Histologic Type

Lymphoproliferative Disorders

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Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

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Peripheral T-cell Lymphoma

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All Drugs and Chemicals

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Gemcitabine

Dexamethasone

Mitoxantrone

Cisplatin

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Antineoplastic Agents, Hormonal

Antimetabolites

Enzyme Inhibitors

Patients with recurrent and refractory peripheral T-cell lymphoma will receive sequentially higher doses of liposomal mitoxantrone hydrochloride in combination with gemcitabine, dexamethasone, and cisplatin for 6 cycles (planned) (21 days per cycle).

Drug: Liposomal mitoxantrone hydrochloride (12 mg/m2, 16 mg/m2, 20 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Drug: gemcitabine (1000 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

Drug: dexamethasone (40 mg) will be administered on day 1-4 of each 21-day cycle.

Drug: cisplatin (75 mg/m2) will be administered by an intravenous infusion on day 1 of each 21-day cycle.

liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatin

Daobin Zhou, Dr

Chong Wei, Dr

Hui Liu, Dr

Hebing Zhou, Dr

Zhenling Li, Dr

Chong Wei

Yujun Dong, Dr

This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy mitoxantrone hydrochloride liposome in combination with gemcitabine, dexamethasone, and cisplatin in relapsed/refractory peripheral T-cell lymphoma

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 gemcitabine, dexamethasone, and cisplatin in patients with relapsed or refractory peripheral T-cell lymphoma. Liposomal mitoxantrone hydrochloride will be given on day 1 at three different doses (12 mg/m2，16 mg/m2, 20 mg/m2) and be combined with gemcitabine, dexamethasone, and cisplatin. 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 mitoxantrone hydrochloride liposome at RP2D dose level combined with gemcitabine, dexamethasone, and cisplatin was conducted to explore the efficacy and safety tolerance of the combined regimen.

Mitoxantrone Hydrochloride Liposomes in Combination With GDP in Relapsed/Refractory PTCL

Phase I/II Clinical Study of Mitoxantrone Hydrochloride Liposomes in Combination With Gemcitabine, Dexamethasone, and Cisplatin in Relapsed/Refractory Peripheral T-cell Lymphoma

The ORR was defined as the proportion of patients who achieved CR or PR

CSPC Ouyi Pharmaceutical Co., Ltd.

Peking Union Medical College Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Mitoxantrone Hydrochloride Liposomes in Combination With GDP in Relapsed/Refractory PTCL	NCT05441761	Treatment Peripheral T-ce...	liposomal mitox...	18 Years - 75 Years	Peking Union Medical College Hospital
Mitoxantrone Hydrochloride Liposomes in Combination With GDP in Relapsed/Refractory PTCL	NCT05441761	Treatment Peripheral T-ce...	liposomal mitox...	18 Years - 75 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatin