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This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients.
Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and Chidamide, and the response and side effects are observed and documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | In this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide | Drug | Chidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective remission rate(ORR) | the rate of patients who achieve objective remission after the treatment,including CR (complete remission),CRu (complete remission with unrecovered platelet count) and PR (partial remission). | every 3 months until 24 months after the last patient's enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| duration of remission | from date of complete remission to date of progression, relapse, or death from any cause | from the day of remission to the date of first documented progression,up to 24 months after the last patient's enrollment |
| progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongwei Xue, MD. PhD | Contact | (+86)13475875599 | Xuehongwei1867@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35170082 | Derived | Wang Y, Zhang M, Song W, Cai Q, Zhang L, Sun X, Zou L, Zhang H, Wang L, Xue H. Chidamide plus prednisone, etoposide, and thalidomide for untreated angioimmunoblastic T-cell lymphoma in a Chinese population: A multicenter phase II trial. Am J Hematol. 2022 May;97(5):623-629. doi: 10.1002/ajh.26499. Epub 2022 Mar 11. |
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After the trial is finished, all the data would be available at the principle investigator's location.
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| ID | Term |
|---|---|
| D007119 | Immunoblastic Lymphadenopathy |
| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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single arm trial, patients enrolled would be treated in this arm.
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|
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 24 months after the last patient's enrollment |
| overall survival | from the date of inclusion to date of death, irrespective of cause | 24 months after the last patient's enrollment |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |