Lenalidomide and Sintilimab for Relapsed/Refractory NK/T-cell Lymphoma

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    Beijing Tongren Hospital
Updated on 24 January 2021


The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens.


Pegaspargase is the backbone of treatment for NK/T-cell lymphoma (ENKTCL), and patients with ENKTCL who failed pegaspargase-based regimens have extremely poor survival outcomes. Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). Constitutive activation of NF-kB pathway has been demonstrated to be involved in the development of ENKTCL and plays critical role in therapy resistance. Lenalidomide, an immuno-modulatory drug, has been found to inhibit NF-kB pathway, and synergize with anti-PD-1 antibody in the treatment of multiple myeloma. Thus, we hypothesize that the combination of lenalidomide and sintilimab will further deepen the remission status and benefit patients who failed pegaspargase-based regimens.

Condition NK/T Cell Lymphoma Nos, NK/T Cell Lymphoma Nos, NK/T Cell Lymphoma Nos
Treatment Lenalidomide, Sintilimab
Clinical Study IdentifierNCT04231370
SponsorBeijing Tongren Hospital
Last Modified on24 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have NK/T Cell Lymphoma Nos?
Do you have any of these conditions: Do you have NK/T Cell Lymphoma Nos??
Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria
Previously treated with pegaspargase-based regimens (refractory or relapsed after initial remission)
PET/CT or CT/MRI with at least one objectively evaluable lesion
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 HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis 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
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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