Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Currently, Chidamide is taken twice a week, this comes from cell experiment and phase I clinical trial, which showed that the de-acetylation effect of Chidamide could last for 72 hours after administration. However, daily administration of Chidamide may create a more steady Chidamide concentration, thus improve the de-acetylation effect of Chidamide, so it's necessary to compare the two different ways of administration.
Current study showed that Romidepsin, a HDACI, could activate EBV during the treatment of NKTCL, whether Chidamide, as a novel HDACI, could activate EBV is still not clear, so this problem is worth to be accessed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide BIW | Experimental | Chidamide is given 30mg,5mg/pill,twice a week, for at least 6 weeks |
|
| Chidamide QD | Experimental | Chidamide is given 10mg,5mg/pill, everyday,for at least 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide BIW | Drug | Chidamide is given 30mg, twice a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | through study completion, an average of 30 months | |
| Duration of Response (DOR) | through study completion, an average of 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | through study completion, an average of 30 months | |
| Overall Survival (OS) | through study completion, an average of 30 months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiqiang Huang, Professor | Contact | huanghq@sysucc.org.cn |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36740715 | Derived | Chen J, Zuo Z, Gao Y, Yao X, Guan P, Wang Y, Li Z, Liu Z, Hong JH, Deng P, Chan JY, Cheah DMZ, Lim J, Chai KXY, Chia BKH, Pang JWL, Koh J, Huang D, He H, Sun Y, Liu L, Liu S, Huang Y, Wang X, You H, Saraf SA, Grigoropoulos NF, Li X, Bei J, Kang T, Lim ST, Teh BT, Huang H, Ong CK, Tan J. Aberrant JAK-STAT signaling-mediated chromatin remodeling impairs the sensitivity of NK/T-cell lymphoma to chidamide. Clin Epigenetics. 2023 Feb 6;15(1):19. doi: 10.1186/s13148-023-01436-6. |
Not provided
Not provided
The data of the trial would be accessable on the corresponding website after the trial is finished.
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 6, 2020 | |
| Reset | Mar 23, 2020 | |
| Release | Mar 26, 2020 | |
| Reset | Apr 7, 2020 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2020 | Mar 23, 2020 | |||
| Mar 26, 2020 |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Chidamide QD | Drug | Chidamide is given 10mg,QD |
|
|
| EBV-DNA |
| through study completion, an average of 30 months |
| EBV-antibodies | 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 |
| Apr 7, 2020 |
| D009369 |
| Neoplasms |