Dexamethasone, azacitidine, pegaspargase and tislelizumab with radiotherapy for stage I–II extranodal NK/T‑cell lymphoma
A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
This treatment plan will test whether combining four drugs (dexamethasone, azacitidine, pegaspargase, and tislelizumab) with radiotherapy helps adults with stage I–II extranodal NK/T‑cell lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | tislelizumab |
| Locations | 3 sites (Beijing and 2 other locations) |
| Trial ID | NCT07000617 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with pathologically confirmed extranodal NK/T‑cell lymphoma, Ann Arbor stage I–II, at least one measurable lesion, ECOG 0–2, and adequate blood counts who can attend the Beijing study centers are ideal candidates.
Not a fit: Patients with advanced (stage III–IV) disease, significant cardiac conduction abnormalities, inadequate blood counts, pregnant or breastfeeding individuals, or those unable to travel to the study centers are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this regimen could improve local control and remission rates for early‑stage NK/T‑cell lymphoma and potentially reduce relapse compared with current approaches.
How similar studies have performed: Previous studies combining L‑asparaginase–based chemotherapy and PD‑1 blockade have shown activity in NK/T‑cell lymphoma, but adding azacitidine to this combination alongside radiotherapy is relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.