Tislelizumab Combined Treatment in Refractory Extranodal NK/T-cell Lymphoma
China62 participantsStarted 2021-09-17
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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:
✓. 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.
✕
What they're measuring
1
Overall response rate
Timeframe: Week 12 +/-7 days
Trial details
NCT IDNCT05058755
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
. 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.