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The purpose of this study is to evaluate the efficacy and safety of Chidamide with ICE regimen in patients with relapsed/refractory Peripheral T Cell lymphoma.
Efficacy of the combined regimen is evaluated primarily by objective remission rate, including complete remission, unverified complete remission and partial remission, also by duration of remission, progression free survival, and overall survival.
Safety is accessed by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide with ICE regimen | Experimental | Drugs:Chidamide and ICE regimen (ifosfamide, Mesna,Carboplatin and etoposide): Chidamide 20mg on d1,4,8,11;ifosfamide 1.2g/ m2，d1-4,ivg during 4 hours; Mesna 0.4g, 0,4,8 hours during Ifosfamide transfusion, ivg, d1-4; Carboplatin AUC=4, d2,ivg; etoposide 65mg/m 2, d1-4, ivg. 3 weeks as 1 course, for 6 courses. if the effect is PR or better than PR, go to auto-stem cell transplantation, no further treatment with Chidamide is needed. If the effect is PR or better than PR and no auto-stem cell transplantation available,Chidamide 20mg orally, twice every week, till the end of the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide with ICE regimen | Drug | Chidamide and ICE regimen, dosage described in arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective remission rate | through study completion, an average of 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of remission | through study completion, an average of 30 months | |
| progress free survival | through study completion, an average of 30 months | |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi, Doctor | Contact | 86-15821531560 | drshiyuankai@163.com |
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the data of the trial would be open to the public after the trial is finished
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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 |
| D007053 | Ice |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 |
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| through study completion, an average of 30 months |
| white blood cell count | every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| red blood cell count | every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| blood Hb level | every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| blood platelet count | every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| vital signs | every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| Serum alanine aminotransferase level | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| Serum aspartate transaminase level | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| Serum total bilirubin level | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| Serum direct bilirubin level | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| Serum indirect bilirubin level | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| Serum glutamyltranspeptidase level | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| Serum albumin level | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| Serum ureal nitrogen level | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| Serum creatinin level | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| fasting blood glucose level | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+） | every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| blood LDH level | every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| QTc from ECG | every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |