A Study of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
- Registration Number
- NCT04324879
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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- 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.
- 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) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
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Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration.
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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.
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Has received systemic steroid treatment within 7 days before the first administration.
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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.
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Has palliative radiation therapy within 4 weeks before the first administration.
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Has received surgery, or unhealed wounds within 4 weeks before the first administration.
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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.
- 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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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQ-B3525 tablet TQ-B3525 TQ-B3525 tablet administered orally.
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) assessed by Independent Review Committee (IRC) Baseline up to 18 months Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) Baseline up to 18 months 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.
Overall response rate (ORR) assessed by investigator Baseline up to 18 months Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
Disease control rate（DCR） Baseline up to 18 months Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Overall Survival (OS) Baseline up to 24 months 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.
Disease control rate (DOR) Baseline up to 18 months DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Safety Baseline up to 18 months AE, ADR, and SAE, and withdrawal from the trial for reasons such as safety or tolerability.
Biomarkers Baseline up to 18 months To assess the changes of genes related to PI3K pathway and bypass in the tissues and / or plasma of enrolled patients.
Trial Locations
- Locations (41)
Fifth Medical Center of General Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Tongji Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Tianjin People's Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Luohe Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Chang Gung Hospital
🇨🇳Beijing, Beijing, China
Chinese People's Liberation Army General Hospital
🇨🇳Beijing, Beijing, China
Beijing Shijitan Hospital
🇨🇳Beijing, Beijing, China
Xuanwu Hospital of Capital Medical University
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The Sixth Medical Center of General Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Chinese People's Liberation Army Joint Logistics Support Unit 940 Hospital
🇨🇳Lanzhou, Gansu, China
Foshan First People's Hospital
🇨🇳Foshan, Guangdong, China
Sun-Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Gansu Cancer Hospital
🇨🇳Lanzhou, Gansu, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Hainan Medical College
🇨🇳Haikou, Hainan, China
Cancer Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Hainan Medical College
🇨🇳Haikou, Hainan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China
Jiangsu Provincial Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Weihai Central Hospital
🇨🇳Weihai, Shandong, China
Affiliated to Zhejiang University School of Medicine,Sir Run Run Shaw Hospital
🇨🇳Hangzhou, Zhejiang, China
Weifang People's Hospital
🇨🇳Weifang, Shandong, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
General Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
The Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China