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| Name | Class |
|---|---|
| Peking University International Hospital | OTHER |
| Chinese Academy of Medical Sciences | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPT regimen plus radiotherapy | Experimental | Patients receive 6 cycles of DAPT regimen plus concurrent radiotherapy. The DAPT regimen consists of dexamethasone, azacitidine, pegaspargase and tislelizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAPT regimen plus radiotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | Complete response rate is assessed according to the 2014 Lugano criteria for response assessment of lymphoma. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Objective response rate is assessed according to the 2014 Lugano criteria for response assessment of lymphoma, including complete response and partial response. | From enrollment to the end of treatment at 8 weeks |
| 2-year progression-free survival rate |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory biomarker analyses | Patients' tumor tissue and blood samples will be collected and analyzed to explore predictive biomarkers for treatment response and prognosis. | From enrollment to 2 years after the end of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuqin Song | Contact | +86-10-88196116 | songyuqin622@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | China |
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|
Progression-free survival (PFS) is measured from the time of start of treatment to the time of first progression, relapse after response, death from any cause, or the date of last follow-up. 2-year PFS rate will be estimated using the Kaplan-Meier method. |
| From enrollment to 2 years after the end of treatment |
| 2-year overall survival rate | Overall survival (OS) is defined as the time from the start of treatment to the time of death from any cause or the date of last follow-up. The 2-year OS rate will be estimated using the Kaplan-Meier method. | From enrollment to 2 years after the end of treatment |
| Adverse events | All adverse events will be recorded and graded according to CTCAE 5.0 | From enrollment to the end of treatment at 1 month |
| Peking University Cancer Hospital | Recruiting | Beijing | China |
|
| Peking University International Hospital | Recruiting | Beijing | China |
|
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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