Back to resultsA Study of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
Primary Purpose
Relapsed / Refractory Follicular Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQ-B3525
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed / Refractory Follicular Lymphoma
Eligibility Criteria
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) ；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.
Sites / Locations
- The First Affiliated Hospital of Anhui Medical University
- Beijing Luohe Hospital, Capital Medical University
- Beijing Shijitan Hospital
- Beijing Tsinghua Chang Gung Hospital
- Chinese People's Liberation Army General Hospital
- Fifth Medical Center of General Hospital of Chinese People's Liberation Army
- Peking University People's Hospital
- The Sixth Medical Center of General Hospital of Chinese People's Liberation Army
- Xuanwu Hospital of Capital Medical University
- Fujian Medical University Union Hospital
- Fujian Provincial Cancer Hospital
- First Affiliated Hospital of Xiamen University
- Gansu Cancer Hospital
- Chinese People's Liberation Army Joint Logistics Support Unit 940 Hospital
- Foshan First People's Hospital
- Sun-Yat-Sen University Cancer CenterRecruiting
- Guangdong Provincial People's Hospital
- Guangzhou First People's Hospital
- The First Affiliated Hospital of Guangzhou Medical University
- Cancer Hospital of Guangxi Medical University
- The First Affiliated Hospital of Hainan Medical College
- The Second Affiliated Hospital of Hainan Medical College
- The Fourth Hospital of Hebei Medical University
- Henan Cancer Hospital
- Henan Provincial People's Hospital
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Hunan Cancer Hospital
- Affiliated Hospital of Inner Mongolia Medical University
- Jiangsu Provincial Cancer Hospital
- Affiliated Zhongshan Hospital of Dalian University
- The First Affiliated Hospital of Dalian Medical University
- Weifang People's Hospital
- Weihai Central Hospital
- Tongji Hospital of Tongji University
- Shanxi Provincial Cancer Hospital
- Tianjin People's HospitalRecruiting
- General Hospital of Tianjin Medical University
- Tianjin Medical University Cancer Institute and Hospital
- First People's Hospital of Yunnan Province
- The Second Affiliated Hospital of Kunming Medical University
- Affiliated to Zhejiang University School of Medicine,Sir Run Run Shaw Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TQ-B3525 tablet
Arm Description
TQ-B3525 tablet administered orally.
Outcomes
Primary Outcome Measures
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Secondary Outcome Measures
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.
Overall response rate (ORR) assessed by investigator
Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
Disease control rate（DCR）
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
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.
Disease control rate (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Safety
AE, ADR, and SAE, and withdrawal from the trial for reasons such as safety or tolerability.
Biomarkers
To assess the changes of genes related to PI3K pathway and bypass in the tissues and / or plasma of enrolled patients.
Full Information
NCT ID
NCT04324879
First Posted
March 25, 2020
Last Updated
June 30, 2020
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04324879
Brief Title
A Study of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
Official Title
A Open-label, Single-arm, Multicenter Phase Ⅱ Clinical Trial of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed / Refractory Follicular Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TQ-B3525 tablet
Arm Type
Experimental
Arm Description
TQ-B3525 tablet administered orally.
Intervention Type
Drug
Intervention Name(s)
TQ-B3525
Intervention Description
TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
Primary Outcome Measure Information:
Title
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
Description
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Time Frame
Baseline up to 18 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
Time Frame
Baseline up to 18 months
Title
Overall response rate (ORR) assessed by investigator
Description
Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
Time Frame
Baseline up to 18 months
Title
Disease control rate（DCR）
Description
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time Frame
Baseline up to 18 months
Title
Overall Survival (OS)
Description
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.
Time Frame
Baseline up to 24 months
Title
Disease control rate (DOR)
Description
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time Frame
Baseline up to 18 months
Title
Safety
Description
AE, ADR, and SAE, and withdrawal from the trial for reasons such as safety or tolerability.
Time Frame
Baseline up to 18 months
Title
Biomarkers
Description
To assess the changes of genes related to PI3K pathway and bypass in the tissues and / or plasma of enrolled patients.
Time Frame
Baseline up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) ；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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiming Li, Doctor
Phone
86-20-87343765
Email
lzmsysu@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruixiang Xia
First Name & Middle Initial & Last Name & Degree
Ruixiang Xia
Facility Name
Beijing Luohe Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hebing Zhou
First Name & Middle Initial & Last Name & Degree
Hebing Zhou
Facility Name
Beijing Shijitan Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijing Zhang
First Name & Middle Initial & Last Name & Degree
Weijing Zhang, Doctor
Facility Name
Beijing Tsinghua Chang Gung Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinquan Li
First Name & Middle Initial & Last Name & Degree
Xinquan Li, Doctor
Facility Name
Chinese People's Liberation Army General Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenrong Huang
First Name & Middle Initial & Last Name & Degree
Wenrong Huang
Facility Name
Fifth Medical Center of General Hospital of Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hang Su
First Name & Middle Initial & Last Name & Degree
Hang Su
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenmiao Yang
First Name & Middle Initial & Last Name & Degree
Shenmiao Yang
Facility Name
The Sixth Medical Center of General Hospital of Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Liu
First Name & Middle Initial & Last Name & Degree
Yi Liu
Facility Name
Xuanwu Hospital of Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Su
First Name & Middle Initial & Last Name & Degree
Li Su
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianda Hu
First Name & Middle Initial & Last Name & Degree
Jianda Hu
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Yang
First Name & Middle Initial & Last Name & Degree
Yu Yang
Facility Name
First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Xu
First Name & Middle Initial & Last Name & Degree
Bing Xu
Facility Name
Gansu Cancer Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Cui
First Name & Middle Initial & Last Name & Degree
Jie Cui
Facility Name
Chinese People's Liberation Army Joint Logistics Support Unit 940 Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hai Bai
First Name & Middle Initial & Last Name & Degree
Hai Bai
Facility Name
Foshan First People's Hospital
City
Foshan
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiwen Chen
First Name & Middle Initial & Last Name & Degree
Yiwen Chen
Facility Name
Sun-Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiming Li, Doctor
Phone
86-20-87343765
Email
lzmsysu@163.com
First Name & Middle Initial & Last Name & Degree
Zhiming Li
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyu Li
First Name & Middle Initial & Last Name & Degree
Wenyu Li
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunqing Wang
First Name & Middle Initial & Last Name & Degree
Shunqing Wang
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huo Tan
First Name & Middle Initial & Last Name & Degree
Huo Tan
Facility Name
Cancer Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Cen
First Name & Middle Initial & Last Name & Degree
Hong Cen
Facility Name
The First Affiliated Hospital of Hainan Medical College
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570216
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qunhao Su
First Name & Middle Initial & Last Name & Degree
Qunhao Su
Facility Name
The Second Affiliated Hospital of Hainan Medical College
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haifeng Lin
First Name & Middle Initial & Last Name & Degree
Haifeng Lin
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihong Liu
First Name & Middle Initial & Last Name & Degree
Lihong Liu
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Liu
First Name & Middle Initial & Last Name & Degree
Yanyan Liu
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Sun
First Name & Middle Initial & Last Name & Degree
Kai Sun
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liling Zhang
First Name & Middle Initial & Last Name & Degree
Liling Zhang
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhou
First Name & Middle Initial & Last Name & Degree
Hui Zhou
Facility Name
Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Da Gao
First Name & Middle Initial & Last Name & Degree
Da Gao
Facility Name
Jiangsu Provincial Cancer Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jifeng Feng
First Name & Middle Initial & Last Name & Degree
Jifeng Feng
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiyun Fang
First Name & Middle Initial & Last Name & Degree
Meiyun Fang
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yajie Gao
First Name & Middle Initial & Last Name & Degree
Yajie Gao
Facility Name
Weifang People's Hospital
City
Weifang
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuehong Ran
First Name & Middle Initial & Last Name & Degree
Xuehong Ran
Facility Name
Weihai Central Hospital
City
Weihai
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binghua Wang
First Name & Middle Initial & Last Name & Degree
Binghua Wang
Facility Name
Tongji Hospital of Tongji University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aibin Liang
First Name & Middle Initial & Last Name & Degree
Aibin Liang
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping Su
First Name & Middle Initial & Last Name & Degree
Liping Su
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaqing Wang
First Name & Middle Initial & Last Name & Degree
Huaqing Wang, Doctor
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Fu
First Name & Middle Initial & Last Name & Degree
Rong Fu
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengzi Qian
First Name & Middle Initial & Last Name & Degree
Zhengzi Qian
Facility Name
First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tonghua Yang
First Name & Middle Initial & Last Name & Degree
Tonghua Yang
Facility Name
The Second Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeping Zhou
First Name & Middle Initial & Last Name & Degree
Zeping Zhou
Facility Name
Affiliated to Zhejiang University School of Medicine,Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinwen Huang
First Name & Middle Initial & Last Name & Degree
Jinwen Huang
12. IPD Sharing Statement
Learn more about this trial
A Study of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
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