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
| Name | Class |
|---|---|
| Fujian Cancer Hospital | OTHER_GOV |
| Zhangzhou Affiliated Hospital of Fujian Medical University | OTHER |
| Dongguan People's Hospital | OTHER_GOV |
| Huizhou Municipal Central Hospital |
Not provided
Not provided
Not provided
Not provided
To determine the efficacy and safety of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma.
This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (Overall Response Rate, Complete Response, Partial Response, Overall Survival, Progression Free Survival) and adverse effects of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide combined with Duvillisib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chidamide combined with Duvillisib | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria. | Up to 27 months |
| Complete Response Rate | Complete response (CR) is evaluated according to the Lugano criteria for lymphoma response. | Up to 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Response Rate | Partial response (PR) is evaluated according to the Lugano criteria for lymphoma response. | Up to 27 months |
| Progression Free Survival | Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first. |
Not provided
Inclusion Criteria:
9. The patient or his/her legal representative must provide written informed consent before carrying out any special inspection or procedure of the study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Xu | Contact | +8618750918842 | xubingzhangjian@126.com | |
| Zhifeng Li | Contact | +8613606901162 | lzf_xm@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Xu | The First Aiffiliated hosptical of xiamen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hosptial of Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Sun Yat-sen University | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 27 months |
| Overall Survival | OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point. | Up to 27 months |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided