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This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide plus previous chemotherapy | Experimental | Chidamide 20mg/d Biw p.o. on d1,4,8,11 for of each cycle for 3 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete response | 21 days after 3 cycles of chidamide in combination with chemotherapy (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 1 year | |
| Overall survival | 1 year | |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
Lab at enrollment(unless caused by lymphoma)
Other uncontrollable medical condition that may that may interfere the participation of the study
Pregnant or lactation
HIV infection
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao, MD, PhD | Contact | 64370045 | 610707 | zhao.weili@yahoo.com |
| Pengpeng Xu, MD | Contact | 64370045 | 610707 | xpproc@msn.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200023 | China |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| 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 |
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| Each cycle of treatment and then every 3 months for 1 year(each cycle is 21 days) |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |