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This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.
After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate | the rate of patients who achieve complete remission after the treatment | every 3 months until 30 months after the last patient's enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | from date of inclusion to date of progression, relapse, or death from any cause | from the day of treatment to the date of first documented progression,up to 30 months after the last patient's enrollment |
| duration of remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengming Jin, MD,PhD | Contact | (+86)512-65223637 | suzhouhematology@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhengming Jin, MD,PhD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39229263 | Derived | Zong X, Yang Z, Zhou J, Jin Z, Wu D. Clinical trial: Chidamide plus CHOP improve the survival of newly diagnosed angioimmunoblastic T-cell lymphoma. Front Immunol. 2024 Aug 20;15:1430648. doi: 10.3389/fimmu.2024.1430648. eCollection 2024. |
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All the data would be available at the First Affiliated Hospital after the study is finished
From the time of study finish
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|
|
from date of complete remission to date of progression, relapse, or death from any cause |
| from the day of treatment to the date of first documented progression,up to 30 months after the last patient's enrollment |
| overall survival | from the date of inclusion to date of death, irrespective of cause | 30 months after the last patient's enrollment |
| adverse events | any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure | from the date of first cycle of treatment to 30 months after last patient's enrollment |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| C036337 | VAP-cyclo protocol |
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