Natural killer/T-cell lymphoma (nasal type) is a mature T/NK-cell lymphoma closely associated with Epstein-Barr virus (EBV), with a high prevalence among populations in Asia and South America. It primarily occurs at extranodal sites, including the nasal/paranasal regions, skin, gastrointestinal tract, and other organs. This study focuses on previously untreated patients with early-stage NKTCL (nasal type), exploring a response-adapted comprehensive therapeutic strategy that combines PD-1 monoclonal antibody-based stratified targeted therapy with concurrent radiotherapy. The aim is to provide integrated management for early-stage extranodal NK/T-cell lymphoma (nasal type), and reduce toxicity while improving overall treatment outcomes for patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Administration of PD-1 mAb will start on Day 1 of radiotherapy (C1D1) at a dose of 200 mg via intravenous infusion over 30 minutes or longer, once every 3 weeks, cycle 1 - cycle 6
Concurrent standard involved-site radiotherapy (ISRT)
The dosage of chidamide will follow a dose-escalation design: 20 mg twice weekly (biw) in the first stage, then escalated to 30 mg biw, using the Bayesian Optimal Interval (BOIN) design to determine the recommended dose, followed by dose expansion in the second stage, every 3 weeks, cycle 4 - cycle 6.
Golidocitinib will be administered at a dose of 150 mg once daily (qd), every 3 weeks, cycle 4 - cycle 6.
2-year progression-free survival rate
Progression-free survival is defined as the time from registration to the first occurrence of disease progression or relapse, using 2014 Lugano criteria, or death from any cause. For patients who received subsequent treatment after the interim assessment, the endpoint shall be defined by the event first occurring after the initiation of subsequent treatment.
Time frame: Baseline up to data cut-off (up to 24 months).
Complete Response Rate
The proportion of patients with complete response after 3 cycles, 6 cycles from treatment start, according to the 2014 Lugano Response Criteria.
Time frame: At the end of cycle 3, cycle 6 after treatment start.
Overall Response Rate
The proportion of patients with complete and partial response after 3 cycles, 6 cycles from treatment start, according to the 2014 Lugano Response Criteria.
Time frame: At the end of cycle 3, cycle 6 after treatment start.
2-year overall survival rate
Overall survival is defined as the time from registration to death from any cause.
Time frame: Baseline up to data cut-off (up to 24 months).
2-year event-free survival rate
Event-free survival is defined as the time from registration to event occurrence. An event is defined as one of the following: disease progression, death from any cause, discontinuation of the protocol-specified treatment due to adverse events, or initiation of a new anti-lymphoma therapy.
Time frame: Baseline up to data cut-off (up to 24 months).
Duration of Response
Duration of response is defined as the period from the first response to first evidence of disease progression, relapse or death of any cause.
Time frame: From enrollment to study completion (up to approximately 24 months).
Treatment-Related Adverse Events rate
Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.
Time frame: From enrollment to study completion (up to approximately 24 months).
The change of plasma EB virus DNA load
The change of plasma EB virus DNA load during the treatment
Time frame: Baseline up to data cut-off (up to 24 months).
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