Chemotherapy: Open Access
Open Access
ISSN: 2167-7700
ISSN: 2167-7700
Phase 1 Clinical Research Center, Affiliated Hospital of Guizhou Medical University, Guizhou Province Tumor Hospital, Guiyang, China
Research Article
Pharmacokinetics, Safety Profiles and Efficacy of Liposomal Mitoxantrone Hydrochloride in Patients with Relapse/Refractory Advanced Lymphoma
Author(s): Yunfei Hu*, Weiwei Ouyang, Jing Zhang, Mengxiang Chen, Daoping Qing, Qiangxing Zeng, Ye Huang, Chunyan Hao, Rui Jia, Zhufeng Wu, Shaonan Ni and Yunhong Huang
Background: Compared with conventional mitoxantrone, liposomal mitoxantrone hydrochloride (PLM60) has shown promising antineoplastic effect and better safety profiles in the previous studies, and worth a further evaluation on its pharmacokinetic profiles.
Methods: In this single-center, open-label, randomized, parallel-group study, patients with histologically/cytologically confirmed relapse/refractory non-Hodgkin lymphoma (n=18) and Hodgkin lymphoma (n=6) were randomized to receive PLM60 12 mg/m2, 16 mg/m2 and 20 mg/m2 on day 1 of each 28-day cycle until the completion of 4 cycles treatment, disease progression, intolerable toxicities, or patient/investigator decision to withdraw (whichever occurred first). Blood samples were collected at prespecified timepoint and the primary endpoint was the pharmacokinetic parameters of total mitoxantrone and free mitoxantrone, the second e.. View More»
DOI:
10.35248/2167-7700.23.11.175