Relapsed / Refractory Mantle Cell Lymphoma (MCL)Phase 2NCT04398953
A Study of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)
A Phase 2 study testing TQ-B3525 in people with Relapsed / Refractory Mantle Cell Lymphoma (MCL), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 39 sites in China.
Trial summary
This is a study to evaluate the safety and efficacy of TQ-B3525 tablets in patients with relapsed / refractory mantle cell lymphoma (MCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed / Refractory Mantle Cell Lymphoma (MCL)
- 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
- 102 participants
- Where
- 39 sitesChina
- Study dates
- 20 Jul 2020to Sep 2021
- 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. 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.
Who cannot join
- 1. 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.
Trial locations and contacts
39 sites in 1 country.
Jifeng Feng contact
39 sites in 1 country
China39 sites, 39 recruiting
- Recruiting
Beijing Boren Hospital
Beijing, Beijing Municipality
Kai Hu, xiaohu7079@sina.com
Kai Hu
- Not yet recruiting
Beijing Shijitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
Weijing Zhang, zhangwj3072@163.com
Weijing Zhang
- Not yet recruiting
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yuankai Shi, syuankaipumc@126.com
Yuankai Shi
- Not yet recruiting
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality
Hang Su, suhang307@126.com
Hang Su
- Not yet recruiting
The Third Hospital of Peking University
Beijing, Beijing Municipality
Hongmei Jing, bysyjhm@sina.com
Hongmei Jing
- Recruiting
Affiliated Hospital of Binzhou Medical College
Binzhou, Shandong
Wenzheng Yu, bzywz2009@163.com
Wenzheng Yu
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin
Sujun Gao, sujung1963@163.com
Sujun Gao
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan
Hui Zhou, Zhouhui@126.com
Hui Zhou
- Not yet recruiting
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning
Meiyun Fang, fangmeiyun@aliyun.com
Meiyun Fang
- Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Yajie Gao, gaoyajie100@aliyun.com
Yajie Gao
- Not yet recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Yang Zhang, 1592855479@qq.com
Yang Zhang
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Yu Yang, yangyu901@163.com
Yu Yang
- Not yet recruiting
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian
Jianda Hu, drjiandahu@163.com
Jianda Hu
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Wenyu Li, liwy1206@163.com
Wenyu Li
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Qingqing Cai, 914052383@qq.com
Qingqing Cai
- Not yet recruiting
Anhui Cancer Hospital
Hefei, Anhui
Kaiyang Ding, dingkaiy@126.com
Kaiyang Ding
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Ruiyang Xia, xrx2041@163.com
Ruiyang Xia
- Not yet recruiting
Huai'an first people's Hospital
Huaian, Jiangsu
Chunling Wang, wcl6506@163.com
Chunling Wang
- Not yet recruiting
The Second Hospital of Lanzhou University
Lanzhou, Gansu
Chongyang Wu, wuchy@lzu.edu.cn
Chongyang Wu
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
Yuerong Shuang, shuangyr63@163.com
Yuerong Shuang
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Jifeng Feng, fjif@vip.sina.com
Jifeng Feng
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Bing Chen, chenbing2004@126.com
Bing Chen
- Not yet recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi
Hong Cen, cen_hong@163.com
Hong Cen
- Not yet recruiting
Nantong Tumor Hospital
Nantong, Jiangsu
Xiaohong Xu, xhx107@163.com
Xiaohong Xu
- Not yet recruiting
Qingdao Central Hospital
Qingdao, Shandong
Ling Wang, wldoctor@126.com
Ling Wang
- Not yet recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality
Bing Xiu, xiubing1233@tongji.edu.cn
Bing Xiu
- Recruiting
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Lihong Liu
Lihong Liu
- Not yet recruiting
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu
Zhengming Jin, jinzhengming519519@163.com
Zhengming Jin
- Not yet recruiting
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Shuhua Yi, yishuhua@ihcams.ac.cn
Shuhua Yi
- Not yet recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality
Lihua Qiu, JZXQLH@163.com
Lihua Qiu
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Rong Fu, florai@sina.com
Rong Fu
- Not yet recruiting
Tianjing People's Hospital
Tianjin, Tianjin Municipality
Huaqing Wang, huaqingw@163.com
Huaqing Wang
- Recruiting
Weifang People's Hospital
Weifang, Shandong
Xuehong Ran, ranxuehong1967@163.com
Xuehong Ran
- Not yet recruiting
Weihai Central Hospital
Weihai, Shandong
Binghua Wang
Binghua Wang
- Not yet recruiting
Weihai Municipal Hospital
Weihai, Shandong
Xiuzhi Deng
Xiuzhi Deng
- Not yet recruiting
Shanxi Provincial People's Hospital
Xi’an, Shanxi
Yi Wang
Yi Wang
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Bing Xu, xubingzhangjian@126.com
Bing Xu
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Yufu Li, liyufu439@126.com
Yufu Li
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Lei Zhang
Lei Zhang
About this study
Official title: A Single-arm, Multicenter Phase II Clinical Trial of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)
This is a study to evaluate the safety and efficacy of TQ-B3525 tablets in patients with relapsed / refractory mantle cell lymphoma (MCL).
- Being tested
- TQ-B3525
- Medical subject headings
- Lymphoma, Mantle-Cell
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 investigator.
Measured: up to 12 months
Secondary outcomes (5)
Disease control rate（DCR）
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 12 months
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measured: up to 12 months
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: up to 12 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: 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: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start20 Jul 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed / Refractory Mantle Cell Lymphoma (MCL)Studies 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
- 102 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
- NCT04398953
- Sponsor's protocol ID
- TQ-B3525-II-02
- Status last verified
- Jan 2020
- First submitted
- 19 May 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Phase II Clinical Trial of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)
- ClinicalTrials.gov ID
- NCT04398953
- Acronym / sponsor ID
- TQ-B3525-II-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 22 May 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.
This is a study to evaluate the safety and efficacy of TQ-B3525 tablets in patients with relapsed / refractory mantle cell lymphoma (MCL).
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 (1 listed)
- 1. 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.
Key exclusion criteria (1 listed)
- 1. 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.
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: up to 12 months
Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
5 secondary outcomes
Disease control rate（DCR）
Time frame: up to 12 months
Duration of Response (DOR)
Time frame: up to 12 months
Progression-free survival (PFS)
Time frame: up to 12 months
Overall survival (OS)
Time frame: up to 18 months
Biomarkers
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
Related trials for Relapsed / Refractory Mantle Cell Lymphoma (MCL)
RecruitingPhase 3
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Lymphoma
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
RecruitingPhase 2
Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Mantle Cell Lymphoma
RecruitingPhase 2
Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy
Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
Mantle Cell Lymphoma, B Cell Lymphoma
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.
Jifeng Feng contact
39 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 Mantle Cell Lymphoma (MCL), run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 39 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 1 inclusion and 1 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 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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 Jifeng Feng (fjif@vip.sina.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: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2020.