A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy With or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)

NK/T Cell Lymphoma Nos Clinical Trial

Official title:

A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy With or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365036
• Other study ID #: B2020-040-01
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2020
• Est. completion date: June 2025

Study information

• Verified date: May 2020
• Source: Sun Yat-sen University
• Contact: Qingqing Cai, MD
• Phone: 0086-20-87342823
• Email: caiqq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized, multi-center,phase Ⅲ clinical trail is to compare the safety and efficacy of sequencial chemoradiotherapy with or without toripalimab (PD-1 antibody) for newly diagnosed early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 207
• Est. completion date: June 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• biopsy proved extranodal natural killer/T-cell lymphoma, nasal type;

• newly diagnosed stage I/II patients;

• at least one evaluable lesion;

• ECOG PS 0-2;

• 18-75 years; without other malignancy;

• proper functioning of the major organs.

Exclusion Criteria:

• hemophagocytic syndrome or aggressive NK cell leukemia;

• involvement of central nervous system;

• previously received treatment of chemotherapy, radiotherapy, immunotherapy or -

• biotherapy for lymphoma;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• NK/T Cell Lymphoma Nos

Intervention

Drug:
• Toripalimab
toripalimab 240mg, d1, intravenous drip
• Pegaspargase
pegaspargase, 2000U/m2, d1, intravenous drip
• Gemcitabine
gemcitabine, 1000mg/m2, d1,d8, intravenous drip
• Oxaliplatin
oxaliplatin, 130mg/m2, d1, intravenous drip,

Radiation:
• Definitive intensity-modulated radiotherapy (IMRT)
Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25~26 days

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival (PFS)		3-years
Secondary	complete remission (CR) rate		1-years
Secondary	overall response rate (ORR)		1-years
Secondary	overall survival (OS)		3-years
Secondary	recurrence-free survival (RFS)		3-years
Secondary	event free survival (EFS)		3-years
Secondary	disease-free survival (DFS)		3-years