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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
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.
Liang Wang
Beijing, Beijing Municipality, China
RECRUITINGThe best objective response rate(ORR) over 6 treatment cycles
Overall response rate means sum of complete response rate and partial response rate
Time frame: Within 6 treatment cycles (each cycle is 21 days)
Objective Response Rate(ORR)
Objective response rate means sum of complete response rate and partial response rate
Time frame: At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)
Complete Response (CR)
CR was defined as complete remission evaluated using PET-CT scan or BM test
Time frame: At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)
Progression Free Survival (PFS)
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.
Time frame: From date of enrollment until the date of progression or date of death from any cause, whichever came first, assesed up to 2 years.
Overall Survival (OS)
Overall survival is defined as the time from the date of treatment to the date of death.
Time frame: From date of enrollment until the date of documented death from any cause or follow up, whichever came first, assesed up to 2 years.
Disease Control Rate(DCR)
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
Time frame: Up to 2 years after enrollment.
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Dexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.