A prospective, open-abel, phase 2 clinical study to investigate whether interim Positron Emission Tomography (PET) and Epstein-Barr virus (EBV) DNA-directed therapy can improve the prognosis of localized nasal extranodal NK/T cell lymphoma (ENKTL) patients.
This study aims to evaluate the significance of mid-term PET and EBV DNA-directed therapy for localized nasal ENKTL. Patients receive 2 cycles of ESA (Pegaspargase, Etoposide, Dexamethasone) regimen, then according to the mid-term PET and EBV DNA results, patients are divided into three cohorts: 1) cohort A: patients with Deauville score 1-3 and EBV DNA negative receive sequential radiotherapy and 2 cycles of ESA regimen; 2) cohort B: patients with Deauville score 1-3 and EBV DNA positive receive sequential radiotherapy and 2 cycles of PD-1 monoclonal antibody combined with pegaspargase; 3) cohort C: patients with Deauville score 4-5 receive 2 cycles of PD-1 monoclonal antibody and concurrent radiotherapy, then 2 cycles of PD-1 monoclonal antibody combined with pegaspargase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Pegaspargase, 2500U/m2, i.m. d1; etoposide, 200mg, p.o., d2-d4; Dexamethasone, 40mg, p.o. d2-d4；
Pegaspargase, 2500U/m2, IM, d1; PD-1 monoclonal antibody, 200mg, i.v. d2;
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITING2-year progression-free survival rate
Progression-free survival was defined as the time from the date of randomization until the date of the first disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
2-year overall survival rate
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
2-year PFS and OS rates in the subgroups of interim Deauville score 1-3 with EBV DNA negative, Deauville 1-3 with EBV DNA positive, and Deauville 4-5
PFS was progression-free survival; OS was overall survival.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Objective response rate
Percentage of participants with complete response and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: End of treatment (6-8 weeks after last cycle)
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: End of treatment (6-8 weeks after last cycle)
Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
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PD-1 monoclonal antibody, 200mg, i.v. d1
Time frame: From enrollment to study completion, a maximum of 3 years
Changes of plasma EBV DNA load
Plasma EBV DNA load monitoring
Time frame: From enrollment to study completion, a maximum of 3 years