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

NCT05896813 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-06-09

No results posted yet for this study

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.

Conditions

  • Newly Diagnosed Peripheral T-cell Lymphoma

Interventions

DRUG

CMOP+Chidamide

Cyclophosphamide: 750 mg/m2, d1; Mitoxantrone Hydrochloride Liposome: 20 mg/m2, d1; Vincristine: 1.4 g/m2, d1 (maximum dose of 2 mg), or vindesine 3 mg/m2, d1; Prednisone: 60 mg/m2, d1-d5; Chidamide:20 mg, biw. The treatment is administered every 3 weeks as a cycle and lasts for a total of 6 cycles.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05896813 on ClinicalTrials.gov