Status:
RECRUITING
A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
Lead Sponsor:
Peking University Cancer Hospital & Institute
Collaborating Sponsors:
Peking University International Hospital
Chinese Academy of Medical Sciences
Conditions:
NK/T Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- ECOG-PS 0\~2
- Peripheral blood absolute neutrophil count ≥1.5×10E9/L, platelet count ≥75×10E9/L and hemoglobin ≥90g/L
- Expected survival of at least 3 months
- Capable of understanding the content of this study, agreeing to participate in this study and signing the informed consent.
Exclusion
- 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.
- Patients who received supportive care for anemia, neutropenia or thrombocytopenia within 7 days prior to start of study treatment.
- Patients with severe active bleeding.
- Patients with pulmonary embolism, intracranial hemorrhage or acute cerebral infarction.
- Patients with active infectious disease.
- Patients who are mentally disabled or unable to understand or sign the informed consent form.
- Patients with other conditions judged as ineligible for this study by the investigators.
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT07000617
Start Date
March 21 2025
End Date
December 1 2028
Last Update
June 3 2025
Active Locations (3)
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1
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
2
Peking University Cancer Hospital
Beijing, China
3
Peking University International Hospital
Beijing, China