Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
A Phase Ib/II Clinical Trial of Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
Beijing Tongren Hospital
43 participants
Apr 14, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria11
- 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.
Interventions
Linperlisib: Phase Ib, oral, 80 mg/d, QD; Phase II, oral, RP2D, QD.
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: 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, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06376721