drugset / Trial / NCT03553914
PLM60 for Peripheral T Cell Lymphoma (PTCL)
Phase 1/2
Withdrawn
Conjupro Biotherapeutics, Inc.
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · collab
RandomizedSequentialOpen-labelTreatment
Summary
This is a Phase 1-2, randomized, multicenter, open label study of PLM60 administered via intravenous (IV) infusion in 28 day treatment cycles to adult participants with relapsed or refractory Peripheral T Cell Lymphoma (PTCL).
Timeline
- Start
- 2021-01
- Primary completion
- 2024-01
- Completion
- 2025-01
Publications
- Background Li C, Cui J, Wang C, Li Y, Zhang H, Wang J, Li Y, Zhang L, Zhang L, Guo W, Wang Y. Encapsulation of mitoxantrone into pegylated SUVs enhances its antineoplastic efficacy. Eur J Pharm Biopharm. 2008 Oct;70(2):657-65. doi: 10.1016/j.ejpb.2008.05.019. Epub 2008 Jun 6.
- Background Yang J, Shi Y, Li C, Gui L, Zhao X, Liu P, Han X, Song Y, Li N, Du P, Zhang S. Phase I clinical trial of pegylated liposomal mitoxantrone plm60-s: pharmacokinetics, toxicity and preliminary efficacy. Cancer Chemother Pharmacol. 2014 Sep;74(3):637-46. doi: 10.1007/s00280-014-2523-8. Epub 2014 Jul 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitoxantrone hydrochloride liposome | Unknown | 12 mg/m2 | Intravenous |
| Subject | Mitoxantrone hydrochloride liposome | Unknown | 16 mg/m2 | Intravenous |
| Subject | Mitoxantrone hydrochloride liposome | Unknown | 20 mg/m2 | Intravenous |