Clinical trial NCT07000617: A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NK/T Cell Lymphoma
Keywords: NK/T cell lymphoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
name: Chinese Academy of Medical Sciences
First posted: 2025-06-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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: 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.

Primary outcomes:
measure: Complete response rate
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Objective response rate
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: 2-year progression-free survival rate
timeFrame: From enrollment to 2 years after the end of treatment
measure: 2-year overall survival rate
timeFrame: From enrollment to 2 years after the end of treatment
measure: Adverse events
timeFrame: From enrollment to the end of treatment at 1 month
Other outcomes:
measure: Exploratory biomarker analyses
timeFrame: From enrollment to 2 years after the end of treatment
Locations:
city: Beijing
country: China
facility: National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Beijing
country: China
facility: Peking University International Hospital
Study officials:
References: