A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DAPT regimen plus radiotherapy.
- Who it may be relevant to
- Registry conditions: NK/T Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug 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 clinic
Primary outcome measures
- Complete response rate [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (4)
- Objective response rate [Time frame: From enrollment to the end of treatment at 8 weeks]
- 2-year progression-free survival rate [Time frame: From enrollment to 2 years after the end of treatment]
- 2-year overall survival rate [Time frame: From enrollment to 2 years after the end of treatment]
- Adverse events [Time frame: From enrollment to the end of treatment at 1 month]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking U — Beijing
- Peking University Cancer Hospital — Beijing
- Peking University International Hospital — Beijing
Identifiers
NCT: NCT07000617 · 2024-1-2151