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The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3525 tablet | Experimental | TQ-B3525 tablet administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-B3525 | Drug | TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) assessed by Independent Review Committee (IRC) | Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC. | Baseline up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 18 months |
| Overall response rate (ORR) assessed by investigator |
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Inclusion Criteria:
- 1. Understood and signed an informed consent form. 2. 18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
3. Relapsed / refractory FL. 4. At least one measurable lymph node or extranodal lymphoma lesions. 5. Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ï¼›No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
Exclusion Criteria:
1. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration.
2. Has a history of immunodeficiency diseases. 3. Has multiple factors affecting oral medication. 4. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
5. Has received systemic steroid treatment within 7 days before the first administration.
6. Has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first.
7. Has palliative radiation therapy within 4 weeks before the first administration.
8. Has received surgery, or unhealed wounds within 4 weeks before the first administration.
9. Has a history of autologous hematopoietic stem cell transplant within 3 months or allogeneic hematopoietic stem cell transplant within 6 months.
10.Has cardiovascular disease ≥grade 2 within 6 months before the first administration.
11. Has active hepatitis B or C. 12. Has psychotropic substances abuse or a mental disorder. 13.Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiming Li, Doctor | Contact | 86-20-87343765 | lzmsysu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38627366 | Derived | Wang H, Feng J, Liu Y, Qian Z, Gao D, Ran X, Zhou H, Liu L, Wang B, Fang M, Zhou H, Huang Z, Tao S, Chen Z, Su L, Su H, Yang Y, Xie X, Wu H, Sun P, Hu G, Liang A, Li Z. Phase II study of novel orally PI3Kalpha/delta inhibitor TQ-B3525 in relapsed and/or refractory follicular lymphoma. Signal Transduct Target Ther. 2024 Apr 17;9(1):99. doi: 10.1038/s41392-024-01798-0. |
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Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator. |
| 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 |
| Disease control rate (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | Baseline up to 18 months |
| Safety | AE, ADR, and SAE, and withdrawal from the trial for reasons such as safety or tolerability. | Baseline up to 18 months |
| Biomarkers | To assess the changes of genes related to PI3K pathway and bypass in the tissues and / or plasma of enrolled patients. | Baseline up to 18 months |
| Beijing Luohe Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Beijing Shijitan Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Beijing Tsinghua Chang Gung Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Chinese People's Liberation Army General Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Fifth Medical Center of General Hospital of Chinese People's Liberation Army | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Peking University People's Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| The Sixth Medical Center of General Hospital of Chinese People's Liberation Army | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Xuanwu Hospital of Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Fujian Medical University Union Hospital | Not yet recruiting | Fuzhou | Fujian | 350000 | China |
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| Fujian Provincial Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | 350000 | China |
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| First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | China |
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| Gansu Cancer Hospital | Not yet recruiting | Lanzhou | Gansu | 730050 | China |
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| Chinese People's Liberation Army Joint Logistics Support Unit 940 Hospital | Not yet recruiting | Lanzhou | Gansu | China |
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| Foshan First People's Hospital | Not yet recruiting | Foshan | Guangdong | China |
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| Sun-Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510050 | China |
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| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| Guangzhou First People's Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Cancer Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | China |
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| The First Affiliated Hospital of Hainan Medical College | Not yet recruiting | Haikou | Hainan | 570216 | China |
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| The Second Affiliated Hospital of Hainan Medical College | Not yet recruiting | Haikou | Hainan | China |
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| The Fourth Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450008 | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | China |
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| Affiliated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Inner Mongolia | China |
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| Jiangsu Provincial Cancer Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
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| Affiliated Zhongshan Hospital of Dalian University | Not yet recruiting | Dalian | Liaoning | China |
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| The First Affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | China |
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| Weifang People's Hospital | Not yet recruiting | Weifang | Shandong | China |
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| Weihai Central Hospital | Not yet recruiting | Weihai | Shandong | China |
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| Tongji Hospital of Tongji University | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Shanxi Provincial Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | China |
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| Tianjin People's Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| General Hospital of Tianjin Medical University | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| First People's Hospital of Yunnan Province | Not yet recruiting | Kunming | Yunnan | 650100 | China |
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| The Second Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | China |
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| Affiliated to Zhejiang University School of Medicine,Sir Run Run Shaw Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| 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 |
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| ID | Term |
|---|---|
| C000730996 | TQ-B3525 |
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