Tislelizumab Combined Treatment in Refractory Extranodal NK/T-cell Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    62
  • sponsor
    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Updated on 3 October 2021

Summary

Natural killer/T-cell lymphoma (NKTCL) patients with relapsed/refractory disease had very poor outcome. Anti-PD-1 antibody showed promising results in response, but but the complete remission rate of was low. Some anti-PD-1 antibody based regimen showed higher and deeper response in NKTCL patients.

Description

About 20-30% of early-stage patients and 40-60% of late-stage NKTCL patients will experience disease relapse and refractory disease, and the median survival time of relapsed patients is about 6 months. PD-1 antibody is an effective drug for the treatment of patients with relapsed/refractory NKTCL, but the response rate and complete remission rate of monotherapy are low. How to improve the prognosis of patients is an important way to try combination therapy. In this study, we aim to explore the effectiveness and safety of a novel anti-PD-1 antibody, tislelizumab, in combination with different drugs (tislelizumab plus azacytidine and lenalidomide, or tislelizumab plus etoposide and pegaspargase) to treat refractory NK/T.

Details
Condition Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Treatment tislelizumab, azacytidine, lenalidomide, tislelizumab, etoposide, pegaspargase
Clinical Study IdentifierNCT05058755
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Last Modified on3 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with biopsy histopathology, immunohistochemistry and EBER test meet ing the WHO 2016 diagnostic criteria for NK/T cell lymphoma
With progressive disease after asparaginase-based combined chemotherapy
Have experienced multiple courses of PD-1/PD-L1 treatment with non-responsive or progressive disease
PET/CT or CT/MRI with at least one measurable lesion or objectively evaluable lesion
General ECOG score 0-3 points
The laboratory examination 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. Blood coagulation
test: plasma fibrinogen 1.0g/L. Heart function: LVEF50%, ECG did not indicate
any acute myocardial infarction, arrhythmia, or atrioventricular block of
degree I or more
\. Signed informed consent form
\. Voluntarily comply with research protocols, follow-up plans, laboratory
and auxiliary examinations

Exclusion Criteria

Patients with a history of pancreatitis (only patients who are planning to undergo PD1 combined with pegaspargase are excluded)
Severe infections require ICU treatment
Combined HCV or HIV infection. Patients with HBV infection who receive antiviral treatment at the same time will not be excluded
There are serious complications such as fulminant DIC
Impairment of important organ functions: such as respiratory failure, chronic congestive heart failure with NYHA grade 2, decompensated liver or kidney insufficiency, hypertension and diabetes that cannot be controlled despite active treatment, nearly 6 years old There were cardio-cerebrovascular thrombotic or hemorrhagic events within months
Pregnant and lactating women
Have a history of autoimmune diseases, have disease activity in the past 6 months, and are still receiving oral immunosuppressive therapy within the past three months, and the daily dose of oral prednisone is greater than 10 mg
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