Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tongren Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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；
Trial design
Design model
Single group
Treatments tested in this trial
Linperlisib
DrugLinperlisib: Phase Ib, oral, 80 mg/d, QD; Phase II, oral, RP2D, QD.
Camrelizumab
DrugCamrelizumab 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
DrugPegaspargase: 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
DrugDexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: treatment armExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
The 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)Secondary outcomes
1
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)2
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)3
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.4
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.Other outcomes
1
Drug safety
According to NCI CTCAE v5.0
Time frame
up to 2 years after enrollmentSponsors and contacts
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Source ClinicalTrials.gov