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)

May 7, 2020 updated by: Qingqing Cai, Sun Yat-sen University
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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

207

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangdong General Hospital
        • Contact:
          • Wenyu Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: toripalimab with P-GemOx
Patients will receive toripalimab and induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent toripalimab of 240mg will be administered every 3 weeks for 3 cycles during IMRT. Toripalimab 240mg will be given every 3 weeks for 13 cycles, started on day 1 of induction chemotherapy.
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
Active Comparator: P-GemOx
Patients will receive induction chemotherapy with pegaspargase, gemcitabine, oxaliplatin, every 3 weeks for 4 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival (PFS)
Time Frame: 3-years
3-years

Secondary Outcome Measures

Outcome Measure
Time Frame
complete remission (CR) rate
Time Frame: 1-years
1-years
overall response rate (ORR)
Time Frame: 1-years
1-years
overall survival (OS)
Time Frame: 3-years
3-years
recurrence-free survival (RFS)
Time Frame: 3-years
3-years
event free survival (EFS)
Time Frame: 3-years
3-years
disease-free survival (DFS)
Time Frame: 3-years
3-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2020-040-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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