Back to resultsA 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)
Primary Purpose
NK/T Cell Lymphoma Nos
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Pegaspargase
Gemcitabine
Oxaliplatin
Definitive intensity-modulated radiotherapy (IMRT)
Sponsored by
About this trial
This is an interventional treatment trial for NK/T Cell Lymphoma Nos
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；
Sites / Locations
- Guangdong General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
toripalimab with P-GemOx
P-GemOx
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
progression free survival (PFS)
Secondary Outcome Measures
complete remission (CR) rate
overall response rate (ORR)
overall survival (OS)
recurrence-free survival (RFS)
event free survival (EFS)
disease-free survival (DFS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04365036
Brief 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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NK/T Cell Lymphoma Nos
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
toripalimab with P-GemOx
Arm Type
Experimental
Arm Description
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.
Arm Title
P-GemOx
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Intervention Description
toripalimab 240mg, d1, intravenous drip
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Intervention Description
pegaspargase, 2000U/m2, d1, intravenous drip
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
gemcitabine, 1000mg/m2, d1,d8, intravenous drip
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
oxaliplatin, 130mg/m2, d1, intravenous drip,
Intervention Type
Radiation
Intervention Name(s)
Definitive intensity-modulated radiotherapy (IMRT)
Intervention Description
Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25~26 days
Primary Outcome Measure Information:
Title
progression free survival (PFS)
Time Frame
3-years
Secondary Outcome Measure Information:
Title
complete remission (CR) rate
Time Frame
1-years
Title
overall response rate (ORR)
Time Frame
1-years
Title
overall survival (OS)
Time Frame
3-years
Title
recurrence-free survival (RFS)
Time Frame
3-years
Title
event free survival (EFS)
Time Frame
3-years
Title
disease-free survival (DFS)
Time Frame
3-years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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；
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Cai, MD
Phone
0086-20-87342823
Email
caiqq@sysucc.org.cn
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyu Li, MD
12. IPD Sharing Statement
Learn more about this trial
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)
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