About this trial
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 criteria
Qualifiers
Pathologically confirmed diagnosis of extranodal NK/T-cell lymphoma
Age ≥18 years
Ann Arbor stage I or II
Presence of at least 1 measurable lesion according to the 2014 Lugano revised criteria for response assessment
Disqualifiers
Unconfirmed pathological diagnosis of NK/T-cell lymphoma
Pregnant or lactating women, or patients of childbearing age unwilling to take contraceptive measures during the study period.
Patients with clinically significant prolonged QTc interval (>470ms in males, >480ms in females), ventricular tachycardia, atrial fibrillation, second or third degree atrioventricular block, acute myocardial infarction, congestive heart failure, severe or symptomatic coronary artery disease requiring medical treatment.
Patients with large amount of pericardial effusions shown by echocardiogram.
Trial design
Treatments tested in this trial
- DAPT regimen plus radiotherapy
Treatment groups
Sponsors and collaborators
Peking University Cancer Hospital & Institute
Lead sponsor
Peking University International Hospital
Collaborator
Chinese Academy of Medical Sciences
Collaborator