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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
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The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of Dexamethasone, azacytidine, Pegaspargase, Tislelizumab (DAPT) regimen for patients with newly diagnosed advanced stage ENKTL
, non-upper aerodigestive tract NK/T- cell lymphoma(NUAT- NKTCL)and relapsed refractory NK/T cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma | Experimental | 4-6 cycles of induction DAPT followed by Auto HSCT as consolidation for CR/PR fit patients ,then by PD-1 as maintenance treatment (up to 16 cycles) for received Auto-HSCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone, azacytidine, Pegaspargase, Tislelizumab | Drug | Dexamethasone 40mg intravenously daily on day 1-4; azacytidine 100mg intravenously daily on day 1-5; Pegaspargase 3750 IU intravenously daily on day 1ï¼› Tislelizumab 200 mg IV on Day 1 of each 21-day as a cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | 1-year | |
| Progression-free survival | 2-year | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Zhu, Dr. | Contact | +86-13910333346 | zhu-jun@bjcancer.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 100021 | China |
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| 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 |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D001374 | Azacitidine |
| C042705 | pegaspargase |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| 2-year |
| Adverse events | 1-year |
| Peking University International Hospital | Beijing | Beijing Municipality | 100021 | China |
|
| Peking University Cancer Hospital & Institute | Beijing | Beijing Municipality | 100142 | China |
| D009369 |
| Neoplasms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |