Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04417166
PHASE2

Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma

Sponsor: International Extranodal Lymphoma Study Group (IELSG)

View on ClinicalTrials.gov

Summary

Aim of the trial is to evaluate the activity and tolerability of the anti PD1 agent Pembrolizumab in combination with RadioTherapy for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma who are not eligible to chemotherapy. It is planned to enroll 30 patients in chinese sites. All eligible patients will be treated with standard radiotherapy and concurrent pembrolizumab administered intravenously every 3 weeks. After 6 cycles of pembrolizumab patients with complete remission, partial response and stable disease will continue with pembrolizumab maintenance up to 2 years. Patients will be followed up to 4 years from treatment start.

Official title: Pembrolizumab and Radiotherapy for Previously Untreated Patients With Limited Stage NK/T Cell Lymphoma Who Are Not Eligible to Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-02-11

Completion Date

2026-12

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

50 mg powder for concentrate for solution for infusion

RADIATION

Involved Field Radiation Therapy

50-54 Gy Involved Field Radiation Therapy (IFRT) as proposed by the International Lymphoma Radiation Oncology Group (ILROG) guidelines. 50 Gy is recommended in patients without primary tumor invasiveness (invasion to adjacent tissue and/or organs), 54 Gy in locally advanced cases (invasion to adjacent tissue and/or organs) or with other risk factors (age \> 60 years, stage II, elevated serum LDH levels). Intensity modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT) are recommended but not mandatory; 3-dimensional conformal RT (3D-CRT) is allowed.

Locations (2)

Sun Yat-sen University Cancer Center

Guangzhou, China

Shanghai Rui-Jin Hospital

Shanghai, China