A Study of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)

June 30, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Open-label, Single-arm, Multicenter Phase Ⅱ Clinical Trial of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)

The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Ruixiang Xia
        • Principal Investigator:
          • Ruixiang Xia
    • Beijing
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Luohe Hospital, Capital Medical University
        • Contact:
          • Hebing Zhou
        • Principal Investigator:
          • Hebing Zhou
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Shijitan Hospital
        • Principal Investigator:
          • Weijing Zhang, Doctor
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Tsinghua Chang Gung Hospital
        • Contact:
          • Xinquan Li
        • Principal Investigator:
          • Xinquan Li, Doctor
      • Beijing, Beijing, China
        • Not yet recruiting
        • Chinese People's Liberation Army General Hospital
        • Contact:
          • Wenrong Huang
        • Principal Investigator:
          • Wenrong Huang
      • Beijing, Beijing, China
        • Not yet recruiting
        • Fifth Medical Center of General Hospital of Chinese People's Liberation Army
      • Beijing, Beijing, China
        • Not yet recruiting
        • Peking University People's Hospital
        • Contact:
          • Shenmiao Yang
      • Beijing, Beijing, China
        • Not yet recruiting
        • The Sixth Medical Center of General Hospital of Chinese People's Liberation Army
        • Contact:
          • Yi Liu
        • Principal Investigator:
          • Yi Liu
      • Beijing, Beijing, China
        • Not yet recruiting
        • Xuanwu Hospital of Capital Medical University
        • Contact:
          • Li Su
        • Principal Investigator:
          • Li Su
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian provincial Cancer Hospital
      • Xiamen, Fujian, China
        • Not yet recruiting
        • First Affiliated Hospital of Xiamen University
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • Gansu Cancer Hospital
        • Contact:
          • Jie Cui
        • Principal Investigator:
          • Jie Cui
      • Lanzhou, Gansu, China
        • Not yet recruiting
        • Chinese People's Liberation Army Joint Logistics Support Unit 940 Hospital
        • Contact:
          • Hai Bai
        • Principal Investigator:
          • Hai Bai
    • Guangdong
      • Foshan, Guangdong, China
        • Not yet recruiting
        • Foshan First People's Hospital
        • Contact:
          • Yiwen Chen
        • Principal Investigator:
          • Yiwen Chen
      • Guangzhou, Guangdong, China, 510050
        • Recruiting
        • SUN-YAT-SEN University Cancer Center
        • Contact:
        • Principal Investigator:
          • Zhiming Li
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangzhou First People's Hospital
        • Contact:
          • Shunqing Wang
        • Principal Investigator:
          • Shunqing Wang
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Huo Tan
        • Principal Investigator:
          • Huo Tan
    • Guangxi
      • Nanning, Guangxi, China
        • Not yet recruiting
        • Cancer Hospital of Guangxi Medical University
        • Contact:
          • Hong Cen
    • Hainan
      • Haikou, Hainan, China, 570216
        • Not yet recruiting
        • The First Affiliated Hospital Of Hainan Medical College
        • Contact:
          • Qunhao Su
        • Principal Investigator:
          • Qunhao Su
      • Haikou, Hainan, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Hainan Medical College
        • Contact:
          • Haifeng Lin
        • Principal Investigator:
          • Haifeng Lin
    • Hebei
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
          • Yanyan Liu
        • Principal Investigator:
          • Yanyan Liu
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • Kai Sun
        • Principal Investigator:
          • Kai Sun
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Liling Zhang
        • Principal Investigator:
          • Liling Zhang
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Hui Zhou
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • Not yet recruiting
        • Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
          • Da Gao
        • Principal Investigator:
          • Da Gao
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Jiangsu Provincial Cancer Hospital
    • Liaoning
      • Dalian, Liaoning, China
        • Not yet recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
          • Yajie Gao
      • Dalian, Liaoning, China
        • Not yet recruiting
        • Affiliated Zhongshan Hospital of Dalian University
        • Contact:
          • Meiyun Fang
    • Shandong
      • Weifang, Shandong, China
        • Not yet recruiting
        • Weifang People's Hospital
        • Contact:
          • Xuehong Ran
      • Weihai, Shandong, China
        • Not yet recruiting
        • Weihai Central Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Tongji Hospital of Tongji University
        • Principal Investigator:
          • Aibin Liang
    • Shanxi
      • Taiyuan, Shanxi, China
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
          • Liping Su
    • Tianjin
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • General Hospital of Tianjin Medical University
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin People's Hospital
        • Contact:
          • Huaqing Wang
        • Principal Investigator:
          • Huaqing Wang, Doctor
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Zhengzi Qian
        • Principal Investigator:
          • Zhengzi Qian
    • Yunnan
      • Kunming, Yunnan, China, 650100
        • Not yet recruiting
        • First People's Hospital of Yunnan Province
        • Contact:
          • Tonghua Yang
        • Principal Investigator:
          • Tonghua Yang
      • Kunming, Yunnan, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Kunming Medical University
        • Contact:
          • Zeping Zhou
        • Principal Investigator:
          • Zeping Zhou
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Not yet recruiting
        • Affiliated to Zhejiang University School of Medicine,Sir Run Run Shaw Hospital
        • Contact:
          • Jinwen Huang
        • Principal Investigator:
          • Jinwen Huang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQ-B3525 tablet
TQ-B3525 tablet administered orally.
Drug: TQ-B3525
TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
Time Frame: Baseline up to 18 months
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Baseline up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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.
Baseline up to 18 months
Overall response rate (ORR) assessed by investigator
Time Frame: Baseline up to 18 months
Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
Baseline up to 18 months
Disease control rate（DCR）
Time Frame: Baseline up to 18 months
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Baseline up to 18 months
Overall Survival (OS)
Time Frame: 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.
Baseline up to 24 months
Disease control rate (DOR)
Time Frame: 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.
Baseline up to 18 months
Safety
Time Frame: Baseline up to 18 months
AE, ADR, and SAE, and withdrawal from the trial for reasons such as safety or tolerability.
Baseline up to 18 months
Biomarkers
Time Frame: 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.
Baseline up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ-B3525-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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