Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    20
  • sponsor
    Beijing Tongren Hospital
Updated on 25 January 2021
renal function

Summary

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with decitabine in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients

Description

Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). However, the CR rate of PD-1 antibody monotherapy is too low. Previous studies have demonstrated that decitabine may activate the T cells and enhance the efficacy of PD-1 antibodies in Hodgkin Lymphoma. Thus, the investigators aim to evaluate the efficacy and safety of sintilimab in combination with decitabine in the treatment of NK/T cell lymphoma.

Details
Condition Angiocentric T-cell lymphoma, T-Cell Lymphoma, extranodal nk/t-cell lymphoma
Treatment Decitabine, Sintilimab
Clinical Study IdentifierNCT04279379
SponsorBeijing Tongren Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: T-Cell Lymphoma or Angiocentric T-cell lymphoma?
Do you have any of these conditions: T-Cell Lymphoma or Angiocentric T-cell lymphoma or extranodal nk/t-cell lymphoma?
Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell
lymphoma according to WHO 2016 criteria
refractory or relapsed after initial remission, or stage III-IV de novo patients
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>5010e9/L. Liver function: ALT, AST, TBIL 2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking
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Exclusion Criteria

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 notexcluded
Significant organ dysfunction Pregnant and lactating women. Had a history of
autoimmune diseases, and disease was active in the last 6 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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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