Sintilimab, Pegaspargase and Anlotinib for Stage IV Natural Killer /T-cell Lymphoma

  • End date
    Dec 30, 2022
  • participants needed
  • sponsor
    Rong Tao
Updated on 11 February 2022


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.


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.

Condition Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Treatment LEAP regimen
Clinical Study IdentifierNCT04004572
SponsorRong Tao
Last Modified on11 February 2022


Yes No Not Sure

Inclusion Criteria

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
Blood routine: Hb>80g/L, PLT>50109/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: LVEF50%, ECG does not suggest any acute
myocardial infarction, arrhythmia or atrioventricular conduction above I
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Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations

Exclusion Criteria

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
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
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