Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT07189065
A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Rocbrutinib, Bendamustine and Rituximab in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Guangzhou Lupeng Pharmaceutical Company LTD. at 41 sites in China.
Trial summary
This is an open-label, randomized controlled, multicenter Phase II clinical study primarily evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR/R2 regimen in patients with non-GCB DLBCL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- Rocbrutinib, Bendamustine and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 41 sitesChina
- Study dates
- 27 Nov 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years, any gender.
- Pathologically confirmed DLBCL (not otherwise specified) according to the revised 2017 WHO classification of lymphoid neoplasms, with non-germinal center B-cell-like (non-GCB) subtype confirmed by Han's algorithm (Appendix 1), based on previous pathological records or confirmed during screening. Must be able to provide sufficient tumor tissue or slides (from previous or screening biopsies) for central laboratory confirmation of pathological diagnosis (if the local pathology report is clear, patients may be enrolled and start treatment without waiting for the central pathology report).
- Patients who are refractory or have relapsed after at least two prior lines of therapy (at least one line must include an anti-CD20 antibody-containing regimen) (see section 6.3 for definition of refractory or relapsed).
- At least one measurable lesion (nodal lesion with longest diameter >1.5 cm, extranodal lesion with longest diameter >1.0 cm).
- Not planned for autologous stem cell transplantation (ASCT).
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.
Who cannot join
- Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission).
- DLBCL resulting from histological transformation of an previously diagnosed indolent lymphoma [such as follicular lymphoma (FL), marginal zone lymphoma, chronic lymphocytic leukemia, etc.] or pathological findings suggesting concomitant FL (any grade).
- Diagnosis of other types of large B-cell lymphoma or special types of DLBCL, including but not limited to high-grade B-cell lymphoma, EBV-positive DLBCL, T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal large B-cell lymphoma, etc.
- Previous exposure to Lobertinib or known allergy to any excipient of Lobertinib (including microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fumaric acid, and gastric-soluble film coating premix); allergy or intolerance to Rituximab or any of its excipients; allergy or intolerance to both Bendamustine and Lenalidomide or any of their excipients.
- Previous refractoriness to BTK-targeting drugs.
- Patients who have received autologous stem cell transplantation within 90 days prior to randomization; patients who have received allogeneic stem cell transplantation.
Trial locations and contacts
41 sites in 1 country. Contact the study team or a site near you to ask about taking part.
41 sites in 1 country
China41 sites, 41 recruiting
- Not yet recruiting
Beijing Shijitan Hospital
Beijing, Beijing Municipality
Kaili Zhong, 86+18911357792, kellyzhong0095@163.com
- Not yet recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality
Liang Wang, 86+15001108693, wangliangtrhos@126.com
- Recruiting
National Cancer Center/Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yuankai Shi, 86+13701251865, syuankaipumc@126.com
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Hongmei Jing, 86+15611908428, bysyjhm@sina.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan
Hui Zhou, 86+13975879796, zhouhui9403@126.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Jin'an Ma, 86+13973192715, 3420248369@qq.com
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan
Huangming Hong, 86+13570431657, honghuangming@scszlyy.org.cn
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Xiaoqiong Tang, 86+13638332366, taoxiang@hjcro.com
- Not yet recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Xiuhua Sun, 86+17709873631, 3038668@vip.sina.com
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Hongming He, 86+13799361913, 811488521@qq.com
- Not yet recruiting
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Min Zhou, 86+13729897904, syxzhoumin@163.com
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Wenyu Li, 86+13924196915, gcpliwy@126.com
- Not yet recruiting
Nanfang Hospital
Guangzhou, Guangdong
Xiaolei Wei, 86+13826407312, SMUxiaoleiwei@163.com
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Wenjuan Yu, 86+13750853563, drwjyu@163.com
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Wenbin Qian, 86+13605801032, qianwenb@hotmail.com
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Haiyan Yang, 86+13857182590, Haiyanyang1125@163.com
- Not yet recruiting
Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital)
Hefei, Anhui
Kaiyang Ding, 86+18900518383, dingkaiy@126.com
- Not yet recruiting
The First Hospital of Jilin University
Jilin City, Jilin
Sujun Gao, 86+15843073208, sujung1963@163.com
- Not yet recruiting
Linyi Cancer Hospital
Linyi, Shandong
Meifang Zheng, 86+13697812656, Lymf666@126.com
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Ling Qin, 86+13838837729, zzqq777@126.com
- Not yet recruiting
Meizhou People's Hospital
Meizhou, Guangdong
Guowu Wu, 86+13823801920, wwwflay@126.com
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
Wuping Li, 86+13870659916, 18907001021@163.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Fei Li, 86+13970038386, yx021021@sina.com
- Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Weiyan Tang, 86+13770542791, msjl8585@sina.com
- Not yet recruiting
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi
Xiaohong Tan, 86+13877193237, tanxhong@163.com
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Zhigang Peng, 86+13977167015, drpzg001@163.com
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Junning Cao, 86+13651680209, cao_junning@126.com
- Not yet recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning
Xiaojing Xing, 86+13940066477, 13940066477@163.com
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Wei Yang, 86+18940251012, sjyangw@163.com
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Yuhuan Gao, 86+13503217908, ydsygao@sina.com
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Zhengming Jin, 86+13862553199, jinzhengming519519@163.com
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
Weiwei Tian, 86+13485304136, tianweiwei@yeah.net
- Not yet recruiting
Shanxi Province Cancer Hospital
Taiyuan, Shanxi
Liping Su, 86+13835158122, slpsy2022@163.com
- Not yet recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Liang Huang, 86+13971600192, huangliang@ihcams.ac.cn
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei
Huijing Wu, 86+13986195042, Wuhuijing8034@126.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Liling Zhang, 86+15871725926, lily1228@sina.com
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Hujian
Zhifeng Li, 86+13606901162, lzf_xm@163.com
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Zhenyu Li, 86+15950688971, lizhenyumd@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Yanyan Liu, 86+13838176375, vvliu@zzu.edu.cn
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Zunmin Zhu, 86+13838565629, zhuzm1964@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Mingzhi Zhang, 86+13838565629, mingzhi_zhang@126.com
About this study
Official title: An Open-Label, Randomized Controlled, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib Monotherapy Versus Investigator's Choice of Therapy in Patients With Relapsed or Refractory Non-GCB Diffuse Large B-Cell Lymphoma
This is an open-label, randomized controlled, multicenter Phase II clinical study primarily evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR/R2 regimen in patients with non-GCB DLBCL.
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Being tested
- Rocbrutinib, Bendamustine, Rituximab, Lenalidomide
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocbrutinibDrug
200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc.
BendamustineDrug
Participants will receive a total of 6 cycles (a cycle being 28 days) 90 mg/m2 Bendamustine (IV infusion) on Days 1 and 2 of Cycles 1-6.
RituximabDrug
Participants will receive a total of 6 cycles (a cycle being 28 days) of 375 mg/m2 Rituximab (IV infusion) on Day 1 of each cycle.
LenalidomideDrug
20mg qd PO day 1-21
| Study group | Role | What they receive |
|---|---|---|
| Rocbrutinib | Experimental | Not described Receives: Drug: Rocbrutinib |
| BR/R2 | Active comparator | Not described Receives: Drug: Bendamustine; Drug: Rituximab; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
Measured: Up to 24 Months
Secondary outcomes (7)
Overall Response Rate
To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by investigator.
Measured: Up to 24 Months
Complete remission rate
To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on complete remission rate (CR) as assessed by investigator and IRC.
Measured: Up to 24 Months
Progression Free Survival
To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Progression Free Survival (PFS) as assessed by investigator and IRC.
Measured: Up to 24 months
Overall survival
To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Overall survival (OS) as assessed by investigator and IRC.
Measured: Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.
Duration of Response (DOR)
To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Duration of response (DOR) as assessed by the Investigator and IRC.
Measured: Up to 24 months
Time to Response (TTR)
To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Time to response (TTR) as assessed by the Investigator and IRC.
Measured: Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.
Safety Assessment
To evaluate the safety of Rocbrutinib and BR/R2 by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
Measured: From first dose of study drug to 28 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start27 Nov 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- More trials run by Guangzhou Lupeng Pharmaceutical Company 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189065
- Sponsor's protocol ID
- LP-168-CN203
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized Controlled, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib Monotherapy Versus Investigator's Choice of Therapy in Patients With Relapsed or Refractory Non-GCB Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07189065
- Acronym / sponsor ID
- LP-168-CN203
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Sep 2025 (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 an open-label, randomized controlled, multicenter Phase II clinical study primarily evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR/R2 regimen in patients with non-GCB DLBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocbrutinib | Experimental | Drug: Rocbrutinib |
| BR/R2 | Active comparator | Drug: Bendamustine, Drug: Rituximab, Drug: Lenalidomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years, any gender.
- Pathologically confirmed DLBCL (not otherwise specified) according to the revised 2017 WHO classification of lymphoid neoplasms, with non-germinal center B-cell-like (non-GCB) subtype confirmed by Han's algorithm (Appendix 1), based on previous pathological records or confirmed during screening. Must be able to provide sufficient tumor tissue or slides (from previous or screening biopsies) for central laboratory confirmation of pathological diagnosis (if the local pathology report is clear, patients may be enrolled and start treatment without waiting for the central pathology report).
- Patients who are refractory or have relapsed after at least two prior lines of therapy (at least one line must include an anti-CD20 antibody-containing regimen) (see section 6.3 for definition of refractory or relapsed).
- At least one measurable lesion (nodal lesion with longest diameter >1.5 cm, extranodal lesion with longest diameter >1.0 cm).
- Not planned for autologous stem cell transplantation (ASCT).
Key exclusion criteria (6 listed)
- Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission).
- DLBCL resulting from histological transformation of an previously diagnosed indolent lymphoma [such as follicular lymphoma (FL), marginal zone lymphoma, chronic lymphocytic leukemia, etc.] or pathological findings suggesting concomitant FL (any grade).
- Diagnosis of other types of large B-cell lymphoma or special types of DLBCL, including but not limited to high-grade B-cell lymphoma, EBV-positive DLBCL, T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal large B-cell lymphoma, etc.
- Previous exposure to Lobertinib or known allergy to any excipient of Lobertinib (including microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fumaric acid, and gastric-soluble film coating premix); allergy or intolerance to Rituximab or any of its excipients; allergy or intolerance to both Bendamustine and Lenalidomide or any of their excipients.
- Previous refractoriness to BTK-targeting drugs.
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 |
|---|---|---|
| Rocbrutinib200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc. | Drug | Rocbrutinib |
| BendamustineParticipants will receive a total of 6 cycles (a cycle being 28 days) 90 mg/m2 Bendamustine (IV infusion) on Days 1 and 2 of Cycles 1-6. | Drug | BR/R2 |
| RituximabParticipants will receive a total of 6 cycles (a cycle being 28 days) of 375 mg/m2 Rituximab (IV infusion) on Day 1 of each cycle. | Drug | BR/R2 |
| Lenalidomide20mg qd PO day 1-21 | Drug | BR/R2 |
Primary outcome
Overall Response Rate
Time frame: Up to 24 Months
To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
7 secondary outcomes
Overall Response Rate
Time frame: Up to 24 Months
Complete remission rate
Time frame: Up to 24 Months
Progression Free Survival
Time frame: Up to 24 months
Overall survival
Time frame: Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.
Duration of Response (DOR)
Time frame: Up to 24 months
Time to Response (TTR)
Time frame: Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.
Safety Assessment
Time frame: From first dose of study drug to 28 days after last dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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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.
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 Rocbrutinib, Bendamustine and Rituximab in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Guangzhou Lupeng Pharmaceutical Company 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuankai Shi (86+010-87788293, syuankaipumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Up to 24 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 16 Dec 2025.