A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma
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
1 other identifier
interventional
150
1 country
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2025
Typical duration for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2025
CompletedFirst Posted
Study publicly available on registry
September 23, 2025
CompletedStudy Start
First participant enrolled
November 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
December 16, 2025
December 1, 2025
2.1 years
September 16, 2025
December 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Up to 24 Months
Secondary Outcomes (7)
Overall Response Rate
Up to 24 Months
Complete remission rate
Up to 24 Months
Progression Free Survival
Up to 24 months
Overall survival
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)
Up to 24 months
- +2 more secondary outcomes
Study Arms (2)
Rocbrutinib
EXPERIMENTALBR/R2
ACTIVE COMPARATORInterventions
200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital)
Hefei, Anhui, China
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
National Cancer Center/Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital of Xiamen University
Xiamen, Hujian, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Jilin, Jilin, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Linyi Cancer Hospital
Linyi, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2025
First Posted
September 23, 2025
Study Start
November 27, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
December 16, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share