NCT05441761

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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 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.

Conditions

• Treatment
• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	liposomal mitoxantrone hydrochloride, gemcitabine, dexamethasone, and cisplatin	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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2022-07-01
• Last updated: 2022-07-01

Locations

5 sites across 1 country: China