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To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.
Prednisone, cyclophosphamide, etoposide, and methotrexate regimens are derived from a "metronidazole, etoposide, procarbazine and cyclophosphamide (PEPC) regimen" regimen that differs from the traditional "maximal Tolerance "chemotherapy, and the use of low-dose chemotherapy, frequent drug therapy, the purpose is to anti-angiogenesis and reduce drug resistance. At present, the program in our treatment of relapsed or refractory PTCL patients effective, safe and controllable, but also look forward to other joint treatment, so as to achieve better curative effect. To provide new treatment options for such patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy regimen | Experimental | Chidamide + prednisone+cyclophosphamide+etoposide+methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | the total proportion of patients with complete response(CR or CRu)and partial response(PR) | every 8 weeks until 2 years after last patient's enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | Duration of complete response(CR or CRu)and partial response(PR) | every 8 weeks until 2 years after last patient's enrollment |
| Progress Free Survival(PFS) | Time from treatment until disease progression or death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiming Li, MD | Contact | 86-20-87343765 | lizhm@sysucc.org.cn | |
| Yu Wang, MD | Contact | 86-20-87343349 | wangyu@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wenqi Jiang, MD | Department of Medical Oncology,Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology,Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D012008 | Recurrence |
| 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 |
| D011241 | Prednisone |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| prednisone | Drug | oral, 20mg / day,after breakfast |
|
| Cyclophosphamide | Drug | oral, 50mg / day,after lunch |
|
| etoposide | Drug | oral, 50mg / day,after dinner |
|
| Methotrexate | Drug | oral, 10mg / times, once a week,after breakfast |
|
| 2 years |
| Overall Survival | Time from treatment until death from any cause | 2 years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |