Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypePhase 2NCT04004572
Sintilimab, Pegaspargase and Anlotinib for Stage IV Natural Killer /T-cell Lymphoma
A Phase 2 study testing LEAP regimen in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Rong Tao at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
- What is being tested?
- LEAP regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.
- Stage IV disease according Lugano 2014 staging system. Newly diagnosed patients, or relapsed disease without a history of asparaginase-containing regimen.
- PET/CT or CT/MRI with at least one objectively evaluable lesion.
- The age is greater than 65 years old. Those who are younger than 65 years should have a documented history unfit for high-dose combination chemotherapy (ie. high doses of methotrexate or high doses of dexamethasone, or autologous hematopoietic stem cell transplantation).
- General status ECOG score 0-3 points.
- The laboratory test within 1 week before enrollment meets the following conditions:
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- Blood routine: Hb>80g/L, PLT>50×109/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Coagulation : plasma fibrinogen ≥ 1.0g / L. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
- Sign the informed consent form.
- Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.
Who cannot join
- Patients with a history of pancreatitis.
- Active infection requires ICU treatment.
- Concomitant HCV or HIV infection. Patients who are infected with HBV at the same time are not excluded.
- Serious complications such as fulminant DIC.
- Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months.
- Pregnant and lactating women.
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- Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three months.
- For the treatment, the daily dose of oral prednisone is greater than 10 mg.
- Those who were known to be allergic to drugs in the study regimen.
- Patients with other tumors who require surgery or chemotherapy within 6 months.
- Other experimental drugs are being used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Prospective Study of the Efficacy and Safety of PD-1 Antibody (Sintilimab) in Combination With Pegaspargase and Erlotinib in the Treatment of Stage IV Extranodal NK/T-cell Lymphoma Unfit for High-intensity Chemotherapy
The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
Read the detailed description
Stage IV NK/T-cell lymphoma has a poor prognosis, and autologous hematopoietic stem cell transplantation can improve the prognosis of patients who have achieved remission after chemotherapy. The median survival time for patients who were not suitable for transplantation was about 1 year. Asparaginase is the backbone drug for the treatment of NK/T-cell lymphoma. PD-1 antibody is effective for relapsed/refractory NK/T-cell lymphoma. Our previous study found that anlotinib is active in relapsed/refractory NK/T Cell lymphoma. This study is aimed to investigate the efficacy and safety of Sintilimab, a PD-1 antibody approved in China, in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
- Being tested
- LEAP regimen
- Keywords
- Natural killer/T-cell lymphoma, Sintilimab, Pegaspargase, Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEAP regimenDrug
Also called Pegaspargase, Sintilimab, Anlotinib
Patients will be given LEAP regimen every 3 weeks for 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| LEAP Regimen | Experimental | Pegaspargase, 2500IU/m2, im, day 1 Sintilimab, 200mg, iv day1 Anlotinib, 8mg, oral, day 1-14 The LEAP regimen will be repeated every 3 weeks. Receives: Drug: LEAP regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
The complete response rate will be assessed on week 24.
Measured: Week 24 +/-7 days
Secondary outcomes (4)
Progression free survival
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Measured: 1-year
Overall response rate
The overall response rate will be assessed on Week 24
Measured: Week 24 +/-7 days
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Measured: Day 1 of each course of chemotherapy and then every 3 months for 1 year
Overall survival
Overall survival is defiend as the time from entry onto the treatment until death of any reason
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Jul 2019
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-TypeStudies of the same condition, open and under way.
- 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rong Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rong Tao, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Rong Tao, MD., PhD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004572
- Sponsor's protocol ID
- XHLSG-NK-1901
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2019
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li D, Liu C, Wan J, Zhang W, Ma Y, Zhu Y, Ma L, Tian S, Ding H, Tao R. Sintilimab, pegaspargase, and anlotinib as induction therapy for advanced-stage NKTCL: a multicenter phase II study. Blood Adv. 2026 Mar 3:bloodadvances.2025018720. doi: 10.1182/bloodadvances.2025018720. Online ahead of print.
PubMed 41774854
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective Study of the Efficacy and Safety of PD-1 Antibody (Sintilimab) in Combination With Pegaspargase and Erlotinib in the Treatment of Stage IV Extranodal NK/T-cell Lymphoma Unfit for High-intensity Chemotherapy
- ClinicalTrials.gov ID
- NCT04004572
- Acronym / sponsor ID
- XHLSG-NK-1901
- Keywords
- Natural killer/T-cell lymphoma, Sintilimab, Pegaspargase, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Rong TaoUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 2 Jul 2019 (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 study is to evaluate the efficacy and safety of Sintilimab in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
Detailed description
Stage IV NK/T-cell lymphoma has a poor prognosis, and autologous hematopoietic stem cell transplantation can improve the prognosis of patients who have achieved remission after chemotherapy. The median survival time for patients who were not suitable for transplantation was about 1 year. Asparaginase is the backbone drug for the treatment of NK/T-cell lymphoma. PD-1 antibody is effective for relapsed/refractory NK/T-cell lymphoma. Our previous study found that anlotinib is active in relapsed/refractory NK/T Cell lymphoma. This study is aimed to investigate the efficacy and safety of Sintilimab, a PD-1 antibody approved in China, in combination with Pegaspargase and anlotinib in the treatment of stage IV NK/T-cell lymphoma patients unfit for high-dose chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEAP Regimen | Experimental | Drug: LEAP regimenPegaspargase, 2500IU/m2, im, day 1 Sintilimab, 200mg, iv day1 Anlotinib, 8mg, oral, day 1-14 The LEAP regimen will be repeated every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.
- Stage IV disease according Lugano 2014 staging system. Newly diagnosed patients, or relapsed disease without a history of asparaginase-containing regimen.
- PET/CT or CT/MRI with at least one objectively evaluable lesion.
- The age is greater than 65 years old. Those who are younger than 65 years should have a documented history unfit for high-dose combination chemotherapy (ie. high doses of methotrexate or high doses of dexamethasone, or autologous hematopoietic stem cell transplantation).
- General status ECOG score 0-3 points.
Key exclusion criteria (11 listed)
- Patients with a history of pancreatitis.
- Active infection requires ICU treatment.
- Concomitant HCV or HIV infection. Patients who are infected with HBV at the same time are not excluded.
- Serious complications such as fulminant DIC.
- Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months.
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 |
|---|---|---|
| LEAP regimenAlso: Pegaspargase, Sintilimab, AnlotinibPatients will be given LEAP regimen every 3 weeks for 8 cycles. | Drug | LEAP Regimen |
Primary outcome
Complete response rate
Time frame: Week 24 +/-7 days
The complete response rate will be assessed on week 24.
4 secondary outcomes
Progression free survival
Time frame: 1-year
Overall response rate
Time frame: Week 24 +/-7 days
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Day 1 of each course of chemotherapy and then every 3 months for 1 year
Overall survival
Time frame: 1-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Derived from this study: PubMed 41774854Li D, Liu C, Wan J, Zhang W, Ma Y, Zhu Y, Ma L, Tian S, Ding H, Tao R. Sintilimab, pegaspargase, and anlotinib as induction therapy for advanced-stage NKTCL: a multicenter phase II study. Blood Adv. 2026 Mar 3:bloodadvances.2025018720. doi: 10.1182/bloodadvances.2025018720. Online ahead of print.
- 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. This study is not recruiting at the moment.
Rong Tao, MD., PhD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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 LEAP regimen in people with Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type, run by Rong Tao 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 11 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: finished, as of the sponsor's last update on 3 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: Week 24 +/-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04004572, which also lists 1 linked publication.
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 3 Aug 2026.