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Recruiting NCT04365036

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)

Phase III Interventional NK/T Cell Lymphoma Nos

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Toripalimab, Pegaspargase, Gemcitabine, Oxaliplatin.
Who it may be relevant to
Registry conditions: NK/T Cell Lymphoma Nos. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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)

Interventions

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

Primary outcome measures

  • progression free survival (PFS) [Time frame: 3 years]
Secondary outcome measures (6)
  • complete remission (CR) rate [Time frame: From the start of treatment with the interventions until 6 months]
  • overall response rate (ORR) [Time frame: From the start of treatment with the interventions until 6 months]
  • overall survival (OS) [Time frame: 3 years]
  • recurrence-free survival (RFS) [Time frame: 3 years]
  • event free survival (EFS) [Time frame: 3 years]
  • disease-free survival (DFS) [Time frame: 3 years]

Eligibility criteria

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；

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Guangdong General Hospital — Guangzhou

Identifiers

NCT: NCT04365036 · B2020-040-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗