A Study of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)
- Registration Number
- NCT04398953
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
This is a study to evaluate the safety and efficacy of TQ-B3525 tablets in patients with relapsed / refractory mantle cell lymphoma (MCL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 102
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- Understood and signed an informed consent form; 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months; 3. Relapsed / refractory MCL; 4. Has received at least one-line and less than four lines of previous treatment, the latest treatment confirmed no objective response, or disease progress after treatment; 5. Has at least one measurable lesion; 6. Adequate organ system function; 7. 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 central nervous system violation; 2. Has received other PI3K inhibitors; 3. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 4. Has history of interstitial lung disease; 5. Has a history of immunodeficiency diseases; 6. Has multiple factors affecting oral medication; 7. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 8. Has received systemic steroid treatment within 7 days before the first administration; 9. 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; 10. Has palliative radiation therapy within 4 weeks before the first administration; 11. Has active infections within 4 weeks before the first administration; 12. Has received surgery, or unhealed wounds within 4 weeks before the first administration; 13. Has a history of autologous hematopoietic stem cell transplant within 6 months or allogeneic hematopoietic stem cell transplant; 14. QTCF > 480ms, LVEF < 50%; 15. Urinary protein ≥ 2 +, and urinary protein quantity >1.0 g in 24 hours within 7 days; 16. Has active hepatitis B or C; 17. Has psychotropic substances abuse or a mental disorder; 18. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
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) up to 12 months Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) up to 12 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.
Biomarkers up to 12 months To assess the changes of genes related to PI3K pathway and bypass in the tissues and / or plasma of enrolled patients.
Duration of Response (DOR) up to 12 months DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Overall survival (OS) up to 18 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（DCR） up to 12 months Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Trial Locations
- Locations (39)
Anhui Cancer Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Boren Hospital
🇨🇳Beijing, Beijing, China
Beijing Shijitan Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Cancer Hospital of Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The Fifth Medical Center of PLA General Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Union Hospital Affiliated to Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The Third Hospital of Peking University
🇨🇳Beijing, Beijing, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The Second Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Nanning, Guangxi Zhuang Autonomous Region, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Huai'an first people's Hospital
🇨🇳Huaian, Jiangsu, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Suzhou University
🇨🇳Suzhou, Jiangsu, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
Affiliated Zhongshan Hospital of Dalian University
🇨🇳Dalian, Liaoning, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
The Second Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Affiliated Hospital of Binzhou Medical College
🇨🇳Binzhou, Shandong, China
Qingdao Central Hospital
🇨🇳Qingdao, Shandong, China
Weifang People's Hospital
🇨🇳Weifang, Shandong, China
Weihai Central Hospital
🇨🇳Weihai, Shandong, China
Shanghai Tongji Hospital
🇨🇳Shanghai, Shanghai, China
Weihai Municipal Hospital
🇨🇳Weihai, Shandong, China
Shanxi Provincial People's Hospital
🇨🇳Xi'an, Shanxi, China
Hematology Hospital of Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Tianjing People's Hospital
🇨🇳Tianjin, Tianjin, China