GDP in Frontline Chemotherapy for Patients With PTCL-NOS

Lymphoma, T-Cell, Peripheral Clinical Trial

Official title: The Efficacy and Toxicity of GDP Chemotherapy in Patients With Peripheral T-cell Lymphoma: An Open-label, Single-arm, Phase II Clinical Trial

Status Recruiting

Clinical Trial Summary

This study is to evaluate the efficacy and safety of GDP (gemcitabine, dexamethasone, and cisplatin) chemotherapy in patients with peripheral T-cell lymphoma-NOS as frontline treatment.

Clinical Trial Description

Peripheral T-cell lymphomas,not otherwise specified constitutes 25.9% of Peripheral T-cell lymphomas and over 15% of all lymphomas by the World Health Organization classification. Because of the rare presentation and evident heterogeneity of PTCL-NOS, optimal frontline therapy for this disease in the modern era remains unclear. Patients have traditionally been treated with anthracycline-containing chemotherapy such as CHOP or CHOP-like regimen used in B-cell NHLs. This strategy is associated with an overall response rate higher than 60%, but the 5-year PFS and OS rates have been reported to be as low as approximately 20-30%.Better therapeutic regimens are in highly need to improve the survival outcome of these patients. The investigators' previous study reported an ORR of 64% in relapsed/refractory PTCL-NOS patients. Therefore, the investigators design this study to evaluate the efficacy and safety of GDP chemotherapy as frontline treatment in patients with PTCL-NOS. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral

• NCT number: NCT02404571
• Study type: Interventional
• Source: Chinese Academy of Medical Sciences
• Contact: Mei Dong
• Phone: (86)13811929322
• Email: dongmei030224@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2011
• Completion date: December 2016