Concurrent Tislelizumab and Radiotherapy in Newly Diagnosed Extranodal NK/T-cell Lymphoma, Nasal Type

Lymphoma Clinical Trial

Official title: Phase II Study of Concurrent Tislelizumab and Radiotherapy for Treatment-naïve, Newly Diagnosed Low-risk Extranodal NK/T-cell Lymphoma, Nasal Type

Status Recruiting

Clinical Trial Summary

This clinical trial intends to analyze the efficacy of PD-1 inhibitor combined with radiotherapy for newly diagnosed NK/T-cell lymphoma. The investigational product in this clinical trial is tislelizumab, a PD-1 inhibitor.

As a rationale for using PD-1 inhibitors in patients with NK/T-cell lymphoma, their efficacy has been proved several times mostly in patients with relapsed NK/T-cell lymphoma.

Patients with low-stage NK/T-cell lymphoma usually receive high-concentration cytotoxic chemotherapy combined with radiotherapy, with treatment response rates of approximately 60 to 80%, but 80-90% of them experience hematological and non-hematologic toxicities during treatment.

Therefore, this study intends to determine the efficacy and safety of PD-1 inhibitor(Tislelizumab) combined with radiotherapy as a first-line therapy compared with pre-existing cytotoxic chemotherapy combined with radiotherapy in patients with NK/T-cell lymphoma with low stage and International Prognostic Index.

Clinical Trial Description

This clinical trial intends to analyze the efficacy of PD-1 inhibitor combined with radiotherapy for newly diagnosed NK/T-cell lymphoma. The investigational product in this clinical trial is tislelizumab, a PD-1 inhibitor.

As a rationale for using PD-1 inhibitors in patients with NK/T-cell lymphoma, their efficacy has been proved several times mostly in patients with relapsed NK/T-cell lymphoma.

However, a tumor-immune microenvironment(TIME) analysis at our institution confirmed that patients with relapsed or refractory NK/T-cell lymphoma had a peritumoral microenvironment with suppressed activity of T cells and macrophages (immune suppression, IS), in which case the efficacy of PD-1 inhibitor decreased compared to a more immune-active microenvironment (immune evasion or immune tolerance, IE or IT). On the other hand, most patients who were newly diagnosed with NK/T-cell lymphoma had a peritumoral microenvironment with active T cells and macrophages(IE or IT).

Patients with low-stage(Stage IE or IIE) NK/T-cell lymphoma usually receive high-concentration cytotoxic chemotherapy combined with radiotherapy, with treatment response rates of approximately 60 to 80%, but 80-90% of them experience grade 3 or 4 hematological and non-hematologic toxicities during treatment.

Therefore, based on the tumor microenvironment of NK/T-cell lymphoma, this study intends to determine the efficacy and safety of PD-1 inhibitor(Tislelizumab) combined with radiotherapy as a first-line therapy compared with pre-existing cytotoxic chemotherapy combined with radiotherapy in patients with NK/T-cell lymphoma with low stage and International Prognostic Index. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

• NCT number: NCT05477264
• Study type: Interventional
• Source: Samsung Medical Center
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2, 2023
• Completion date: December 31, 2026