NKTCLPhase 2NCT07574528
A Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma
A Phase 2 study testing Sintilimab, Pegaspargase and Selinexor in people with NKTCL, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a single-arm, open-label, multicenter phase II study evaluating sintilimab, pegaspargase, and selinexor followed by radiotherapy as first-line treatment for patients with newly diagnosed stage I/II extranodal natural killer/T-cell lymphoma (ENKTL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NKTCL
- What is being tested?
- Sintilimab, Pegaspargase and Selinexor
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to 6 May 2031
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- No prior systemic treatment for lymphoma, except short-term corticosteroids for symptom control.
- Life expectancy of more than 3 months.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Histologically confirmed extranodal natural killer/T-cell lymphoma.
- Primary lesion located in the nasal cavity or upper aerodigestive tract.
Show all 9Show fewer
- Stage I to II disease.
- At least one measurable or evaluable lesion according to Lugano 2014 criteria.
- Adequate organ and bone marrow function.
Who cannot join
- Aggressive NK-cell leukemia.
- Significant dysfunction of major organs.
- Known hypersensitivity to any study drug or its components, or contraindication to any study treatment.
- Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use effective contraception.
- Known history of human immunodeficiency virus infection or acquired immunodeficiency syndrome.
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
Sun Yat-sen University Cancer Center
Guangzhou, 广东省 - Guangdong Sheng, 510060
Qingqing Cai, 18353201165, baisr@sysucc.org.cn
About this study
Official title: A Multicenter, Single-Arm, Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma
This is a single-arm, open-label, multicenter phase II study evaluating sintilimab, pegaspargase, and selinexor followed by radiotherapy as first-line treatment for patients with newly diagnosed stage I/II extranodal natural killer/T-cell lymphoma (ENKTL).
- Conditions
- NKTCL
- Being tested
- Sintilimab, Pegaspargase, Selinexor, radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab will be given at 200 mg by intravenous infusion.
PegaspargaseDrug
Pegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection.
SelinexorDrug
Selinexor will be given orally once weekly at 60mg.
radiotherapyRadiation
Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab, pegaspargase, and selinexor | Experimental | Patients will receive induction therapy with sintilimab, pegaspargase, and selinexor every 21 days for up to 4 cycles, followed by radiotherapy. Receives: Drug: Sintilimab; Drug: Pegaspargase; Drug: Selinexor; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (CRR)
The proportion of patients who achieve complete response at the end of radiotherapy, as assessed according to Lugano 2014 response criteria.
Measured: Up to approximately 6 months
Secondary outcomes (5)
Overall Response Rate (ORR)
The proportion of patients who achieve complete response or partial response, as assessed according to Lugano 2014 response criteria.
Measured: Up to approximately 6 months
Progression-Free Survival (PFS)
The time from enrollment to disease progression or death from any cause, whichever occurs first.
Measured: Up to 3 years
Overall Survival (OS)
The time from enrollment to death from any cause.
Measured: Up to 3 years
Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)
The incidence and severity of adverse events, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events.
Measured: Up to 30 days after the last study treatment
Change in Quality of Life
Quality of life will be assessed using the EORTC QLQ-C30 or FACT-G questionnaire.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start6 May 2026 (estimated)
- Primary completion6 Mar 2028 (estimated)
- Study completion6 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NKTCLStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 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
- NCT07574528
- Sponsor's protocol ID
- B2026-235
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Phase II Study of Sintilimab, Pegaspargase and Selinexor Followed by Radiotherapy in Newly Diagnosed Stage I/II Extranodal NK/T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07574528
- Acronym / sponsor ID
- B2026-235
- Conditions
- NKTCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 6 May 2026 (estimated)
- Primary completion
- 6 Mar 2028 (estimated)
- Study completion
- 6 May 2031 (estimated)
- First posted
- 8 May 2026 (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.
This is a single-arm, open-label, multicenter phase II study evaluating sintilimab, pegaspargase, and selinexor followed by radiotherapy as first-line treatment for patients with newly diagnosed stage I/II extranodal natural killer/T-cell lymphoma (ENKTL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab, pegaspargase, and selinexor | Experimental | Drug: Sintilimab, Drug: Pegaspargase, Drug: Selinexor, Radiation: radiotherapyPatients will receive induction therapy with sintilimab, pegaspargase, and selinexor every 21 days for up to 4 cycles, followed by radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 years or older.
- No prior systemic treatment for lymphoma, except short-term corticosteroids for symptom control.
- Life expectancy of more than 3 months.
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Histologically confirmed extranodal natural killer/T-cell lymphoma.
Key exclusion criteria (5 listed)
- Aggressive NK-cell leukemia.
- Significant dysfunction of major organs.
- Known hypersensitivity to any study drug or its components, or contraindication to any study treatment.
- Pregnant or breastfeeding women, or participants of childbearing potential unwilling to use effective contraception.
- Known history of human immunodeficiency virus infection or acquired immunodeficiency syndrome.
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 |
|---|---|---|
| SintilimabSintilimab will be given at 200 mg by intravenous infusion. | Drug | Sintilimab, pegaspargase, and selinexor |
| PegaspargasePegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection. | Drug | Sintilimab, pegaspargase, and selinexor |
| SelinexorSelinexor will be given orally once weekly at 60mg. | Drug | Sintilimab, pegaspargase, and selinexor |
| radiotherapyPatients will receive induction treatment for up to 4 cycles, followed by radiotherapy. | Radiation | Sintilimab, pegaspargase, and selinexor |
Primary outcome
Complete Response Rate (CRR)
Time frame: Up to approximately 6 months
The proportion of patients who achieve complete response at the end of radiotherapy, as assessed according to Lugano 2014 response criteria.
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to approximately 6 months
Progression-Free Survival (PFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)
Time frame: Up to 30 days after the last study treatment
Change in Quality of Life
Time frame: Up to 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 8 May 2026.
- Individual participant dataSharing planned: No
Related trials for NKTCL
RecruitingPhase 3
BRIDGE-NK: Immunotherapy Versus Chemotherapy Induction Followed by Autologous HSCT in Advanced NKTCL
Extranodal NK/T-cell Lymphoma
RecruitingPhase 1/2
Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma
Extranodal NK/T-cell Lymphoma, NK/T-cell Lymphoma
Not yet recruitingPhase 1/2
Adebrelimab Combined With SHR2554 in Relapsed/Refractory PTCL and NK/T-Cell Lymphoma
Relapsed or Refractory Peripheral T Cell Lymphoma, NKTCL
Not yet recruitingObservational study
Multi-modal Fusion Model and Deep Learning for Predicting Treatment Response in NKTCL
Natural Killer/T-cell Lymphoma
RecruitingPhase 1/2
Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatment of NK/T-cell Lymphoma Associated Hemophagocytic Lymphohistiocytosis (NKTCL-HLH)
Extranodal NK T Cell Lymphoma, Hemophagocytic Lymphohistiocytosis (HLH)
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 2 study testing Sintilimab, Pegaspargase and Selinexor in people with NKTCL, 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 9 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 May 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (+8618353201165, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (CRR) (time frame: Up to approximately 6 months). 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 8 May 2026.