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RECRUITING
NCT05477264
PHASE2

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

Sponsor: Won Seog Kim

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2023-03-02

Completion Date

2026-12-31

Last Updated

2024-04-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tislelizumab

Induction therapy: Tislelizumab combined with radiation * Tislelizumab: 200mg, IV at 3-week intervals combined with radiotherapy. * Radiotherapy: 400Gy/20 fractions Maintenance therapy(after termination of combination therapy) * Tislelizumab: 200mg IV at 3-week intervals for up to 2 years until disease progression or intolerance.

Locations (1)

81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

Seoul, South Korea