Actively Recruiting
A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
Led by Peking University Cancer Hospital & Institute · Updated on 2025-06-03
57
Participants Needed
3
Research Sites
193 weeks
Total Duration
On this page
Sponsors
P
Peking University Cancer Hospital & Institute
Lead Sponsor
P
Peking University International Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed diagnosis of extranodal NK/T-cell lymphoma
- Age 18 years or older
- Ann Arbor stage I or II
- At least one measurable lesion according to 2014 Lugano revised criteria
- ECOG performance status 0 to 2
- Peripheral blood neutrophil count 1.5 x 10^9/L, platelet count 7.5 x 10^9/L, and hemoglobin 90 g/L
- Expected survival of at least 3 months
- Able to understand the study, agree to participate, and sign informed consent
You will not qualify if you...
- Unconfirmed pathological diagnosis of NK/T-cell lymphoma
- Pregnant or lactating women, or women of childbearing age not using contraception during the study
- Significant heart problems including prolonged QTc interval, ventricular tachycardia, atrial fibrillation, atrioventricular block, recent heart attack, heart failure, or severe coronary artery disease
- Large pericardial effusions detected by echocardiogram
- Received supportive care for anemia, neutropenia, or thrombocytopenia within 7 days before study treatment
- Severe active bleeding
- Pulmonary embolism, intracranial hemorrhage, or acute cerebral infarction
- Active infectious disease
- Mental disability or inability to understand or sign informed consent
- Other conditions deemed ineligible by investigators
AI-Screening
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Trial Site Locations
Total: 3 locations
1
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Actively Recruiting
2
Peking University Cancer Hospital
Beijing, China
Actively Recruiting
3
Peking University International Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yuqin Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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