Camrelizumab: Camrelizumab for Injection: 200 mg/d, intravenous drip for 30 min (not less than 20 min and not more than 60 min), administered on day 1 of each cycle, observed for 2 hours after infusion. Every 3 weeks is a dosing cycle. Cycle 2 and subsequent cycles of dosing may be administered up to 5 days before or after the day of the scheduled dosing; more than 3 days after the date of the scheduled dosing will be considered a delayed dosing.
Pegaspargase: Pegaspargase: 2500 IU/m2, intramuscular injection, divided into three places, administered on the first day of each cycle, observed 2 hours after injection for the occurrence of anaphylactic reaction, if there is no anaphylactic reaction before giving other test drugs. Every 3 weeks as a dosing cycle.
Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.
Dexamethasone: Dexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
•Sign the informed consent form
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.
Primary outcome measure(s)
The best objective response rate（ORR） over 6 treatment cycles — Within 6 treatment cycles (each cycle is 21 days) Overall response rate means sum of complete response rate and partial response rate
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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