Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
- Conditions
- T-lymphoblastic LymphomaNatural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
- Interventions
- Registration Number
- NCT06376721
- Lead Sponsor
- Beijing Tongren Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 43
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment arm Linperlisib Linperlisib: Phase Ib：oral, 80 mg/d, QD; Phase II： oral, RP2D, QD. Camrelizumab for Injection: Phase Ib \& Phase II：intravenous drip, 200 mg/d, Q3W, administered on day 1 of each cycle (3 weeks in each cycle) Pegaspargase: Phase Ib \& Phase II：intramuscular injection，2500 IU/m2, Q3W, administered on day 1 of each cycle (3 weeks in each cycle) treatment arm Camrelizumab Linperlisib: Phase Ib：oral, 80 mg/d, QD; Phase II： oral, RP2D, QD. Camrelizumab for Injection: Phase Ib \& Phase II：intravenous drip, 200 mg/d, Q3W, administered on day 1 of each cycle (3 weeks in each cycle) Pegaspargase: Phase Ib \& Phase II：intramuscular injection，2500 IU/m2, Q3W, administered on day 1 of each cycle (3 weeks in each cycle) treatment arm Dexamethasone Linperlisib: Phase Ib：oral, 80 mg/d, QD; Phase II： oral, RP2D, QD. Camrelizumab for Injection: Phase Ib \& Phase II：intravenous drip, 200 mg/d, Q3W, administered on day 1 of each cycle (3 weeks in each cycle) Pegaspargase: Phase Ib \& Phase II：intramuscular injection，2500 IU/m2, Q3W, administered on day 1 of each cycle (3 weeks in each cycle) treatment arm Pegaspargase Linperlisib: Phase Ib：oral, 80 mg/d, QD; Phase II： oral, RP2D, QD. Camrelizumab for Injection: Phase Ib \& Phase II：intravenous drip, 200 mg/d, Q3W, administered on day 1 of each cycle (3 weeks in each cycle) Pegaspargase: Phase Ib \& Phase II：intramuscular injection，2500 IU/m2, Q3W, administered on day 1 of each cycle (3 weeks in each cycle)
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) From date of enrollment until the date of progression or date of death from any cause, whichever came first, assesed up to 2 years. Progression free survival was defined as the period from the start of treatment to the date of confirmed disease progression or death from any cause.
Disease Control Rate（DCR） Up to 2 years after enrollment. Disease control rate discribes the percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease
Objective Response Rate（ORR） At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days) Objective response rate means sum of complete response rate and partial response rate
Overall Survival (OS) From date of enrollment until the date of documented death from any cause or follow up, whichever came first, assesed up to 2 years. Overall survival is defined as the time from the date of treatment to the date of death.
Complete Response （CR） At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days) CR was defined as complete remission evaluated using PET-CT scan or BM test
Trial Locations
- Locations (1)
Liang Wang
🇨🇳Beijing, Beijing, China