Dexamethasone, azacitidine, pegaspargase and tislelizumab with radiotherapy for stage I–II extranodal NK/T‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial gives adults with stage I–II extranodal NK/T‑cell lymphoma a combination regimen called DAPT — dexamethasone, azacitidine, pegaspargase and tislelizumab — together with localized radiotherapy. Participants receive the DAPT regimen every 21 days for six cycles while undergoing scheduled blood tests and radiologic imaging to monitor tumor response and safety. The study measures response rates and treatment‑related adverse events to determine whether the combined approach improves disease control. Eligible patients must have measurable disease, ECOG 0–2, and adequate blood counts, while those who are pregnant, breastfeeding, or have serious cardiac conduction abnormalities are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pathologically confirmed diagnosis of extranodal NK/T-cell lymphoma
2. Age ≥18 years
3. Ann Arbor stage I or II
4. Presence of at least 1 measurable lesion according to the 2014 Lugano revised criteria for response assessment
5. ECOG-PS 0\~2
6. Peripheral blood absolute neutrophil count ≥1.5×10E9/L, platelet count ≥75×10E9/L and hemoglobin ≥90g/L
7. Expected survival of at least 3 months
8. Capable of understanding the content of this study, agreeing to participate in this study and signing the informed consent.

Exclusion Criteria:

1. Unconfirmed pathological diagnosis of NK/T-cell lymphoma
2. Pregnant or lactating women, or patients of childbearing age unwilling to take contraceptive measures during the study period.
3. 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.
4. Patients with large amount of pericardial effusions shown by echocardiogram.
5. Patients who received supportive care for anemia, neutropenia or thrombocytopenia within 7 days prior to start of study treatment.
6. Patients with severe active bleeding.
7. Patients with pulmonary embolism, intracranial hemorrhage or acute cerebral infarction.
8. Patients with active infectious disease.
9. Patients who are mentally disabled or unable to understand or sign the informed consent form.
10. Patients with other conditions judged as ineligible for this study by the investigators.

Where it's running

• National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, China Recruiting
• Peking University Cancer Hospital
  Beijing, China Recruiting
• Peking University International Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yuqin Song
• Email: songyuqin622@163.com
• Phone: +86-10-88196116

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.