Clinical trial NCT04324879: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Relapsed / Refractory Follicular Lymphoma
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with 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.

Primary outcomes:
measure: Objective response rate (ORR) assessed by Independent Review Committee (IRC)
timeFrame: Baseline up to 18 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Baseline up to 18 months
measure: Overall response rate (ORR) assessed by investigator
timeFrame: Baseline up to 18 months
measure: Disease control rate（DCR）
timeFrame: Baseline up to 18 months
measure: Overall Survival (OS)
timeFrame: Baseline up to 24 months
measure: Disease control rate (DOR)
timeFrame: Baseline up to 18 months
measure: Safety
timeFrame: Baseline up to 18 months
measure: Biomarkers
timeFrame: Baseline up to 18 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Luohe Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
state: Beijing
city: Beijing
country: China
facility: Fifth Medical Center of General Hospital of Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: The Sixth Medical Center of General Hospital of Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital of Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: First Affiliated Hospital of Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: Gansu Cancer Hospital
state: Gansu
city: Lanzhou
country: China
facility: Chinese People's Liberation Army Joint Logistics Support Unit 940 Hospital
state: Gansu
city: Foshan
country: China
facility: Foshan First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun-Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Nanning
country: China
facility: Cancer Hospital of Guangxi Medical University
state: Guangxi
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical College
state: Hainan
city: Haikou
country: China
facility: The Second Affiliated Hospital of Hainan Medical College
state: Hainan
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Hohhot
country: China
facility: Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Provincial Cancer Hospital
state: Jiangsu
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Weihai
country: China
facility: Weihai Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Kunming
country: China
facility: First People's Hospital of Yunnan Province
state: Yunnan
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Affiliated to Zhejiang University School of Medicine,Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
References: