A Phase Ib/II Clinical Trial of Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment.
• Histopathology and immunohistochemistry confirmed diagnosis of ENKTL according to WHO 2016 criteria.
• refractory or relapsed after initial remission, or Ann-Arbor stage III-IV de novo patients
• PET/CT or CT/MRI with at least one objectively evaluable lesion.
• Expected to survive more than 3 months.
• General status ECOG score 0-2 points.
• The laboratory test within 1 week before enrollment meets the following conditions:
⁃ Blood routine: WBC≥3×10e9/L, PLT≥75×10e9/L, ANC≥1.5×10e9/L. sCR≤1.5 mg/dL,GFR≥50 ml/min. Liver function: ALT \& AST≤3 times the upper limit of normal, TBIL ≤2 times the upper limit of normal.
⁃ Serum fibrinogen level≥1.0 g/L.
⁃ •Sign the informed consent form