RecruitingPhase 2NCT07000617

A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

57 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if the regimen of dexamethasone, azacitidine, pegaspargase and tislelizumab (DAPT regimen) combined with radiotherapy works to treat stage I or II NK/T cell lymphoma in adults. It will also learn about the safety of the DAPT regimen. The main questions it aims to answer are: What are the efficacy of the DAPT regimen plus radiotherapy in participants with extranodal NK/T-cell lymphoma? What medical problems do participants have when taking the DAPT regimen? Participants will: Receive the DAPT regimen every 21 days for 6 cycles and radiotherapy Visit the clinic according to clinical trial requirement for checkups and tests Receive blood tests and radiological imaging tests according to the clinical trial requirement


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This phase II study is testing a combination treatment — dexamethasone (a steroid), azacitidine, pegaspargase, and tislelizumab (an immunotherapy drug) plus radiation therapy — for people with early-stage extranodal NK/T-cell lymphoma, a rare type of blood cancer that often affects the nose and throat. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of extranodal NK/T-cell lymphoma - Your cancer is at stage I or II (early stage, not yet widely spread) - You have at least one tumor that can be measured on a scan - Your blood counts and general health meet the study requirements **You may NOT be eligible if...** - Your diagnosis has not been confirmed by a tissue sample (biopsy) - You are pregnant or breastfeeding, or not willing to use contraception - You have significant heart problems (abnormal heart rhythms, recent heart attack, or heart failure) - You have active bleeding, a blood clot, recent stroke, or active infection - You have a serious psychiatric condition 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

DRUGDAPT regimen plus radiotherapy

Patients receive 6 cycles of DAPT regimen plus concurrent radiotherapy. The DAPT regimen is administered as follows: dexamethasone 10mg intravenously on days1-3, azacitidine 100mg subcutaneously on days 1-5, pegaspargase 2500IU/m2 intramuscularly on day 1, and tislelizumab 200mg intravenously on day 6, repeated every 21 days. Concurrent radiotherapy given to the tumor sites is started after 2 cycles of DAPT regimen. The specific doses and methods of radiotherapy are in accordance with the clinical guidelines for NK/T-cell lymphoma.


Locations(3)

National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Peking University Cancer Hospital

Beijing, China

Peking University International Hospital

Beijing, China

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NCT07000617


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