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Clinical Trials in China / NCT07189065
Recruiting Phase 2

A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma

NCT07189065 · tracked via the Priya Life Science China tracker
Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.
Phase
Phase 2
Started
2025-11-27
Last updated
2025-12-16

Condition(s) studied

Diffuse Large B-Cell Lymphoma (DLBCL)

Investigational drug(s) / intervention(s)

RocbrutinibBendamustineRituximabLenalidomide

Rocbrutinib: 200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc.

Bendamustine: 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.

Rituximab: 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.

Lenalidomide: 20mg qd PO day 1-21

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years, any gender. 2. 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). 3. 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). 4. At least one measurable lesion (nodal lesion with longest diameter \>1.5 cm, extranodal lesion with longest diameter \>1.0 cm). 5. Not planned for autologous stem cell transplantation (ASCT). 6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. Exclusion Criteria: 1. Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission). 2. 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). 3. 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. 4. 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. 5. Previous refractoriness to BTK-targeting drugs. 6. Patients who have received autologous stem cell transplantation within 90 days prior to randomization; patients who have received allogeneic stem cell transplantation.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital) Hefei Anhui Not Yet Recruiting
Beijing Shijitan Hospital Beijing Beijing Municipality Not Yet Recruiting
Beijing Tongren Hospital Beijing Beijing Municipality Not Yet Recruiting
National Cancer Center/Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Peking University Third Hospital Beijing Beijing Municipality Not Yet Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Not Yet Recruiting
Fujian Cancer Hospital Fuzhou Fujian Not Yet Recruiting
Affiliated Cancer Hospital of Guangzhou Medical University Guangzhou Guangdong Not Yet Recruiting
Guangdong Provincial People's Hospital Guangzhou Guangdong Not Yet Recruiting
Nanfang Hospital Guangzhou Guangdong Not Yet Recruiting
Meizhou People's Hospital Meizhou Guangdong Not Yet Recruiting
Affiliated Tumor Hospital of Guangxi Medical University Nanning Guangxi Not Yet Recruiting
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi Not Yet Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Not Yet Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Not Yet Recruiting
Hubei Cancer Hospital Wuhan Hubei Not Yet Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Not Yet Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Hujian Not Yet Recruiting
Hunan Cancer Hospital Changsha Hunan Not Yet Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
Jiangsu Cancer Hospital Nanjing Jiangsu Not Yet Recruiting
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Not Yet Recruiting
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu Not Yet Recruiting
Jiangxi Cancer Hospital Nanchang Jiangxi Not Yet Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Not Yet Recruiting
The First Hospital of Jilin University Jilin City Jilin Not Yet Recruiting
The Second Affiliated Hospital of Dalian Medical University Dalian Liaoning Not Yet Recruiting
Liaoning Cancer Hospital Shenyang Liaoning Not Yet Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Not Yet Recruiting
Linyi Cancer Hospital Linyi Shandong Not Yet Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Not Yet Recruiting
Shanxi Bethune Hospital Taiyuan Shanxi Not Yet Recruiting
Shanxi Province Cancer Hospital Taiyuan Shanxi Not Yet Recruiting
Sichuan Cancer Hospital Chengdu Sichuan Not Yet Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Tianjin Tianjin Municipality Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang Not Yet Recruiting

+ 1 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile → 📄 Revlimid (lenalidomide) drug profile →

More Guangzhou Lupeng Pharmaceutical Company LTD. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07189065 on ClinicalTrials.gov ↗ ← All trials in China