drugset / Trial / NCT05441761
Mitoxantrone Hydrochloride Liposomes in Combination With GDP in Relapsed/Refractory PTCL
Phase 1/2
Unknown
60 enrolled
Peking Union Medical College Hospital
CSPC Ouyi Pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2022-05-01
- Primary completion
- 2025-05-01
- Completion
- 2025-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitoxantrone | Small molecule | 12 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 16 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 20 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |