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To observe the safety, tolerability and clinical effects of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma.
This is a prospective, open-label, one-arm, multicenter clinical trial, aimed to evaluate the safety, tolerability, and efficacy of PD-1 Antibody, Chidamide, Lenalidomide and Etoposide in Relapsed or Refractory NK/T cell Lymphoma. A total of 50 patients are planned to be enrolled into the study. The primary end points are objective responder rate (ORR) and progression free survival(PFS) and the secondary end points include overall survival(OS) , and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 Antibody, chidamide, lenalidomide and etoposide | Experimental | PD-1 Antibody: 240mg, d1, Chidamide: 20mg, twice a week, Lenalidomide: 25mg, d1-14 Etoposide:100mg/m2, d1-3 and 21 days made one treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 Antibody, chidamide, lenalidomide and etoposide | Drug | PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation. | From date of randomization until the date of first date tumor volume has reduced, assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingzhi D Zhang | Contact | +8613838565629 | +8613838565629 | Mingzhi_zhang@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department of The First Affilliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | 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 |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D000077269 | Lenalidomide |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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Time from randomization to death for any reason. |
| From date of randomization until date of death from any cause, assessed up to 36 months |
| D009369 |
| Neoplasms |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |