Overview
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.
Description
This is a prospective, single-arm, single-center Ib/II clinical trial that included an initial safety run-in phase with safety monitoring before the main enrollment (expansion phase).The aim of phase Ib is to evaluate the recommended phase 2 dose and dose-limiting toxicity (DLT), and the aim of phase II study is to evaluate, for the first time, the safety and efficacy of the treatment of Linperlisib combined with PD-1 blockade Camrelizumab and Pegaspargase in patients diagnosed with advanced or r/r ENKTL, respectively.
Eligibility
Inclusion Criteria:
- 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.
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Exclusion Criteria:
- Patients with CNS involvement, or with other neoplasm;
- Patients has received PI3K inhibitor treatment before enrollment
- Poor performance status, ECOG≥2;
- Patients in lactation or pregnancy；
- Patients (male or female) have the possibility of childbirth but are unwilling or have
not taken effective contraceptive measures；
- Patients allergic to any of the study drugs；
- Patients with active infection；
- Patients with a history of immunodeficiency, including HIV positive or other acquired
or congenital immunodeficiency diseases, or a history of organ transplantation;
- Patients with a history of interstitial pneumonia, non infectious pneumonia, or highly
suspected interstitial pneumonia;
- Patients with a history of neurological or psychiatric disorders, including epilepsy
or dementia, in the past
- According to the researcher's judgment, there are accompanying diseases that seriously
endanger patient safety or affect patient completion of the study.