NK/T Cell Lymphoma NosPhase 3NCT04365036
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)
A Phase 3 study testing Toripalimab, Pegaspargase and Gemcitabine in people with NK/T Cell Lymphoma Nos, run by Sun Yat-sen University at 1 site in China.
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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NK/T Cell Lymphoma Nos
- What is being tested?
- Toripalimab, Pegaspargase and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2020to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- hemophagocytic syndrome or aggressive NK cell leukemia;
- involvement of central nervous system;
- previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510000
Wenyu Li, MD
About this study
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)
- Conditions
- NK/T Cell Lymphoma Nos
- Being tested
- Toripalimab, Pegaspargase, Gemcitabine, Oxaliplatin, Definitive intensity-modulated radiotherapy (IMRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
toripalimab 240mg, d1, intravenous drip
PegaspargaseDrug
pegaspargase, 2000U/m2, d1, intravenous drip
GemcitabineDrug
gemcitabine, 1000mg/m2, d1,d8, intravenous drip
OxaliplatinDrug
oxaliplatin, 130mg/m2, d1, intravenous drip,
Definitive intensity-modulated radiotherapy (IMRT)Radiation
Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25~26 days
| Study group | Role | What they receive |
|---|---|---|
| toripalimab with P-GemOx | Experimental | 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. Receives: Drug: Toripalimab; Drug: Pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin; Radiation: Definitive intensity-modulated radiotherapy (IMRT) |
| P-GemOx | Active comparator | 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. Receives: Drug: Pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin; Radiation: Definitive intensity-modulated radiotherapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival (PFS)
Measured: 3 years
Secondary outcomes (6)
complete remission (CR) rate
Measured: From the start of treatment with the interventions until 6 months
overall response rate (ORR)
Measured: From the start of treatment with the interventions until 6 months
overall survival (OS)
Measured: 3 years
recurrence-free survival (RFS)
Measured: 3 years
event free survival (EFS)
Measured: 3 years
disease-free survival (DFS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start3 May 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NK/T Cell Lymphoma NosStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365036
- Sponsor's protocol ID
- B2020-040-01
- Status last verified
- Mar 2025
- First submitted
- 24 Apr 2020
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04365036
- Acronym / sponsor ID
- B2020-040-01
- Conditions
- NK/T Cell Lymphoma Nos
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 3 May 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| toripalimab with P-GemOx | Experimental | Drug: Toripalimab, Drug: Pegaspargase, Drug: Gemcitabine, Drug: Oxaliplatin, Radiation: Definitive intensity-modulated radiotherapy (IMRT)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. |
| P-GemOx | Active comparator | Drug: Pegaspargase, Drug: Gemcitabine, Drug: Oxaliplatin, Radiation: Definitive intensity-modulated radiotherapy (IMRT)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- hemophagocytic syndrome or aggressive NK cell leukemia;
- involvement of central nervous system;
- previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toripalimabtoripalimab 240mg, d1, intravenous drip | Drug | toripalimab with P-GemOx |
| Pegaspargasepegaspargase, 2000U/m2, d1, intravenous drip | Drug | P-GemOx, toripalimab with P-GemOx |
| Gemcitabinegemcitabine, 1000mg/m2, d1,d8, intravenous drip | Drug | P-GemOx, toripalimab with P-GemOx |
| Oxaliplatinoxaliplatin, 130mg/m2, d1, intravenous drip, | Drug | P-GemOx, toripalimab with P-GemOx |
| Definitive intensity-modulated radiotherapy (IMRT)Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25~26 days | Radiation | P-GemOx, toripalimab with P-GemOx |
Primary outcome
progression free survival (PFS)
Time frame: 3 years
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toripalimab, Pegaspargase and Gemcitabine in people with NK/T Cell Lymphoma Nos, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingqing Cai, MD (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.