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This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapse/refactory diffuse large B-cell lymphoma who have received at least 2 lines of therapeutic schedules including rituximab. 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 tablets | Drug | TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) assessed by Independent Review Committee | Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC | Baseline up to 18 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. | Baseline up to 18 months |
| Progression-free survival (PFS) |
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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 | Not yet recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-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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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.
| Baseline up to 18 months |
| Disease control rate(DCR) | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD). | Baseline up to 18 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. | Baseline up to 24 months |
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |