Relapsed / Refractory Follicular LymphomaPhase 2NCT04324879
A Study of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
A Phase 2 study testing TQ-B3525 in people with Relapsed / Refractory Follicular Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 41 sites in China.
Trial summary
The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed / Refractory Follicular Lymphoma
- What is being tested?
- TQ-B3525
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 41 sitesChina
- Study dates
- 20 May 2020to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
China41 sites, 41 recruiting
- Not yet recruiting
Beijing Luohe Hospital, Capital Medical University
Beijing, Beijing Municipality
Hebing Zhou
Hebing Zhou
- Not yet recruiting
Beijing Shijitan Hospital
Beijing, Beijing Municipality
Weijing Zhang
Weijing Zhang, Doctor
- Not yet recruiting
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality
Xinquan Li
Xinquan Li, Doctor
- Not yet recruiting
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality
Wenrong Huang
Wenrong Huang
- Not yet recruiting
Fifth Medical Center of General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality
Hang Su
Hang Su
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Shenmiao Yang
Shenmiao Yang
- Not yet recruiting
The Sixth Medical Center of General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality
Yi Liu
Yi Liu
- Not yet recruiting
Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality
Li Su
Li Su
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan
Hui Zhou
Hui Zhou
- Not yet recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning
Meiyun Fang
Meiyun Fang
- Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Yajie Gao
Yajie Gao
- Not yet recruiting
Foshan First People's Hospital
Foshan, Guangdong
Yiwen Chen
Yiwen Chen
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Jianda Hu
Jianda Hu
- Not yet recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000
Yu Yang
Yu Yang
- Recruiting
Sun-Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510050
Zhiming Li, Doctor, 86-20-87343765, lzmsysu@163.com
Zhiming Li
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Wenyu Li
Wenyu Li
- Not yet recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong
Shunqing Wang
Shunqing Wang
- Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Huo Tan
Huo Tan
- Not yet recruiting
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan, 570216
Qunhao Su
Qunhao Su
- Not yet recruiting
The Second Affiliated Hospital of Hainan Medical College
Haikou, Hainan
Haifeng Lin
Haifeng Lin
- Not yet recruiting
Affiliated to Zhejiang University School of Medicine,Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
Jinwen Huang
Jinwen Huang
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Ruixiang Xia
Ruixiang Xia
- Not yet recruiting
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Da Gao
Da Gao
- Not yet recruiting
First People's Hospital of Yunnan Province
Kunming, Yunnan, 650100
Tonghua Yang
Tonghua Yang
- Not yet recruiting
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Zeping Zhou
Zeping Zhou
- Not yet recruiting
Gansu Cancer Hospital
Lanzhou, Gansu, 730050
Jie Cui
Jie Cui
- Not yet recruiting
Chinese People's Liberation Army Joint Logistics Support Unit 940 Hospital
Lanzhou, Gansu
Hai Bai
Hai Bai
- Not yet recruiting
Jiangsu Provincial Cancer Hospital
Nanjing, Jiangsu
Jifeng Feng
Jifeng Feng
- Not yet recruiting
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi
Hong Cen
Hong Cen
- Not yet recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality
Aibin Liang
Aibin Liang
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Lihong Liu
Lihong Liu
- Not yet recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi
Liping Su
Liping Su
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300000
Huaqing Wang
Huaqing Wang, Doctor
- Not yet recruiting
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Rong Fu
Rong Fu
- Not yet recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Zhengzi Qian
Zhengzi Qian
- Not yet recruiting
Weifang People's Hospital
Weifang, Shandong
Xuehong Ran
Xuehong Ran
- Not yet recruiting
Weihai Central Hospital
Weihai, Shandong
Binghua Wang
Binghua Wang
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Liling Zhang
Liling Zhang
- Not yet recruiting
First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Bing Xu
Bing Xu
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Yanyan Liu
Yanyan Liu
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Kai Sun
Kai Sun
About this study
Official title: 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.
- Being tested
- TQ-B3525
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ-B3525Drug
TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| TQ-B3525 tablet | Experimental | TQ-B3525 tablet administered orally. Receives: Drug: TQ-B3525 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Measured: Baseline up to 18 months
Secondary outcomes (7)
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.
Measured: Baseline up to 18 months
Overall response rate (ORR) assessed by investigator
Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
Measured: Baseline up to 18 months
Disease control rate（DCR）
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: Baseline up to 18 months
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.
Measured: Baseline up to 24 months
Disease control rate (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measured: Baseline up to 18 months
Safety
AE, ADR, and SAE, and withdrawal from the trial for reasons such as safety or tolerability.
Measured: Baseline up to 18 months
Biomarkers
To assess the changes of genes related to PI3K pathway and bypass in the tissues and / or plasma of enrolled patients.
Measured: Baseline up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start20 May 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed / Refractory Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324879
- Sponsor's protocol ID
- TQ-B3525-II-01
- Status last verified
- Jun 2020
- First submitted
- 25 Mar 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang H, Feng J, Liu Y, Qian Z, Gao D, Ran X, Zhou H, Liu L, Wang B, Fang M, Zhou H, Huang Z, Tao S, Chen Z, Su L, Su H, Yang Y, Xie X, Wu H, Sun P, Hu G, Liang A, Li Z. Phase II study of novel orally PI3Kalpha/delta inhibitor TQ-B3525 in relapsed and/or refractory follicular lymphoma. Signal Transduct Target Ther. 2024 Apr 17;9(1):99. doi: 10.1038/s41392-024-01798-0.
PubMed 38627366
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label, Single-arm, Multicenter Phase Ⅱ Clinical Trial of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
- ClinicalTrials.gov ID
- NCT04324879
- Acronym / sponsor ID
- TQ-B3525-II-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQ-B3525 tablet | Experimental | Drug: TQ-B3525TQ-B3525 tablet administered orally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQ-B3525TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle. | Drug | TQ-B3525 tablet |
Primary outcome
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.
7 secondary outcomes
Progression-free survival (PFS)
Time frame: Baseline up to 18 months
Overall response rate (ORR) assessed by investigator
Time frame: Baseline up to 18 months
Disease control rate（DCR）
Time frame: Baseline up to 18 months
Overall Survival (OS)
Time frame: Baseline up to 24 months
Disease control rate (DOR)
Time frame: Baseline up to 18 months
Safety
Time frame: Baseline up to 18 months
Biomarkers
Time frame: Baseline up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Derived from this study: PubMed 38627366Wang H, Feng J, Liu Y, Qian Z, Gao D, Ran X, Zhou H, Liu L, Wang B, Fang M, Zhou H, Huang Z, Tao S, Chen Z, Su L, Su H, Yang Y, Xie X, Wu H, Sun P, Hu G, Liang A, Li Z. Phase II study of novel orally PI3Kalpha/delta inhibitor TQ-B3525 in relapsed and/or refractory follicular lymphoma. Signal Transduct Target Ther. 2024 Apr 17;9(1):99. doi: 10.1038/s41392-024-01798-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQ-B3525 in people with Relapsed / Refractory Follicular Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 41 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiming Li, Doctor (86-20-87343765, lzmsysu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) assessed by Independent Review Committee (IRC) (time frame: Baseline up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.