RecruitingPhase 2NCT04417166

Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma

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


Sponsor

International Extranodal Lymphoma Study Group (IELSG)

Enrollment

30 participants

Start Date

Feb 11, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of immunotherapy (pembrolizumab) and radiation therapy for people with early-stage NK/T-cell lymphoma — a rare type of lymphoma often affecting the nose and sinuses — who are not well enough to receive full-dose chemotherapy. **You may be eligible if...** - You have a confirmed diagnosis of NK/T-cell lymphoma - You have never been treated for this lymphoma before - You are 18 or older - Your disease is at an early stage (stage I or II) and you have at least one high-risk feature (such as age over 60, elevated LDH, or stage II disease) - You are not well enough to receive full standard chemotherapy - You are in generally good health otherwise (ECOG 0–1) **You may NOT be eligible if...** - Your lymphoma has spread to advanced stages (stage III or IV) - You have an autoimmune disease - You have another active cancer that has not been cured - You have a history of severe lung inflammation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

50 mg powder for concentrate for solution for infusion

RADIATIONInvolved 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

View Full Details on ClinicalTrials.gov

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NCT04417166


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