A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
NCT ID: NCT07000617
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
57 participants
INTERVENTIONAL
2025-03-21
2028-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DAPT regimen plus radiotherapy
Patients receive 6 cycles of DAPT regimen plus concurrent radiotherapy. The DAPT regimen consists of dexamethasone, azacitidine, pegaspargase and tislelizumab.
DAPT regimen plus radiotherapy
Patients receive 6 cycles of DAPT regimen plus concurrent radiotherapy. The DAPT regimen is administered as follows: dexamethasone 10mg intravenously on days1-3, azacitidine 100mg subcutaneously on days 1-5, pegaspargase 2500IU/m2 intramuscularly on day 1, and tislelizumab 200mg intravenously on day 6, repeated every 21 days. Concurrent radiotherapy given to the tumor sites is started after 2 cycles of DAPT regimen. The specific doses and methods of radiotherapy are in accordance with the clinical guidelines for NK/T-cell lymphoma.
Interventions
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DAPT regimen plus radiotherapy
Patients receive 6 cycles of DAPT regimen plus concurrent radiotherapy. The DAPT regimen is administered as follows: dexamethasone 10mg intravenously on days1-3, azacitidine 100mg subcutaneously on days 1-5, pegaspargase 2500IU/m2 intramuscularly on day 1, and tislelizumab 200mg intravenously on day 6, repeated every 21 days. Concurrent radiotherapy given to the tumor sites is started after 2 cycles of DAPT regimen. The specific doses and methods of radiotherapy are in accordance with the clinical guidelines for NK/T-cell lymphoma.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Peking University International Hospital
OTHER
Chinese Academy of Medical Sciences
OTHER
Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Locations
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National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, , China
Peking University Cancer Hospital
Beijing, , China
Peking University International Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-1-2151
Identifier Type: -
Identifier Source: org_study_id
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