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This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapse/refactory peripheral T-cell lymphoma who have received at least 1 lines of therapeutic schedules. TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3525 tablets | Experimental | TQ-B3525 tablet administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-B3525 | Drug | TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) by Independent Review Committee | Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) assessed by Investigator | Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator. | up to 6 months |
| Duration of response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi, Doctor | Contact | 010-87788293 | syuankaipumc@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100083 | China | ||
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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 |
|---|---|
| C000730996 | TQ-B3525 |
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DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
| up to 12 months |
| Progression-free survival (PFS) | PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause. | up to 6 months |
| Disease control rate(DCR) | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 12 months |
| Overall survival(OS) | OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. | up to 24 months |
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine |
| Shanghai |
| Shanghai Municipality |
| 200092 |
| China |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |