drugset / Trial / NCT05896813

CMOP Regimen and Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

NCT05896813

NaSingle-groupOpen-labelTreatment

Summary

Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous and aggressive non-Hodgkin's lymphoma. The incidence rate of PTCL in China is much higher than the global average, and there is no unified standard treatment for initial PTCL. Currently, the CHOP regimen is widely used as first-line treatment. However, the overall response rate is still low, and effective therapies need to be explored. Epigenetics and genetics jointly determine critical features of tumors, and exploring new treatment strategies and developing targeted drugs based on deep understanding of the pathogenesis is of significant importance. The combined application of DNMT inhibitors and HDAC inhibitors has strong scientific support. The Phase II clinical study of Mitoxantrone Hydrochloride Liposome in treating relapsed or refractory PTCL achieved positive results and regulatory approval. The CMOP regimen combining Mitoxantrone Hydrochloride Liposome with Chidamide is worth exploring for initial PTCL treatment.

Timeline

Start
2023-03-01
Primary completion
2025-01-01
Completion
2025-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 750 mg/m2
Subject Mitoxantrone Small molecule 20 mg/m2
Subject Prednisone Other / unclassified 60 mg/m2
Subject Tucidinostat Small molecule 20 mg
Subject Vincristine Small molecule 1400 mg/m2
Subject Vindesine Small molecule 3 mg/m2