Actively Recruiting
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
Led by Guangzhou Lupeng Pharmaceutical Company LTD. · Updated on 2025-12-16
150
Participants Needed
41
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR/R2 regimen in patients with relapsed or refractory non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL). This open-label, randomized controlled Phase II clinical study aims to provide new treatment options for patients who have experienced relapse or resistance after prior therapies, including at least one anti-CD20 antibody-containing regimen. Participants are randomly assigned to receive either Rocbrutinib at 200 mg orally once daily until disease progression or unacceptable toxicity, or the investigator's choice of combination therapy consisting of Bendamustine and Rituximab (BR) or Rituximab plus Lenalidomide (R2). The BR regimen involves six 28-day cycles of Bendamustine (90 mg/m2 IV infusion on Days 1 and 2) and Rituximab (375 mg/m2 IV infusion on Day 1 of each cycle), while the R2 regimen includes Rituximab with Lenalidomide at 20 mg orally on Days 1 to 21 of each cycle. Participants will undergo regular assessments including evaluations of overall response rate, complete remission rate, progression-free survival, overall survival, duration and time to response, and safety monitoring up to 24 months, with some outcomes followed for up to five years. Safety is assessed from the first dose until 28 days after the last dose. The total participation duration depends on treatment response and follow-up schedules, with careful monitoring throughout the study to track treatment effects and adverse events.
CONDITIONS
Brief Title
A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Confirmed diagnosis of non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma according to 2017 WHO classification
- Relapsed or refractory after at least two prior lines of therapy, including at least one anti-CD20 antibody-containing regimen
- At least one measurable lesion: nodal >1.5 cm or extranodal >1.0 cm
- Not planning to undergo autologous stem cell transplantation
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
You will not qualify if you...
- Primary central nervous system (CNS) lymphoma or CNS involvement
- DLBCL from transformation of indolent lymphoma or with concomitant follicular lymphoma
- Other types or special subtypes of large B-cell lymphoma (e.g., high-grade B-cell lymphoma, EBV-positive DLBCL)
- Previous use of Lobertinib or allergy to Rocbrutinib or its excipients
- Allergy or intolerance to Rituximab or both Bendamustine and Lenalidomide
- Resistance to BTK-targeting drugs
- Stem cell transplantation within 90 days prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles (approximately 6 months) for BR/R2 arm; Rocbrutinib treatment continues until progression or discontinuation
Participants receive assigned study drugs. Those in the Rocbrutinib arm take 200mg orally once daily until disease progression or unacceptable toxicity. Participants in the BR/R2 arm receive 6 cycles (28 days each) of Bendamustine and Rituximab infusions and Lenalidomide orally on specified days.
Multiple visits for drug administration and monitoring during treatment cycles
Duration - Up to 24 months for response and progression assessments; safety monitoring continues for 28 days after last dose
Participants are monitored for safety and treatment response after completing or discontinuing treatment.
Regular visits during follow-up period
Trial Site Locations
Total: 41 locations
1
Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital)
Hefei, Anhui, China
Not Yet Recruiting
2
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
4
National Cancer Center/Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
5
Peking University Third Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
6
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
7
Fujian Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
8
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
9
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
10
Nanfang Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
11
Meizhou People's Hospital
Meizhou, Guangdong, China
Not Yet Recruiting
12
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Not Yet Recruiting
13
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Not Yet Recruiting
14
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Not Yet Recruiting
15
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Not Yet Recruiting
16
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
17
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
18
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
19
Hubei Cancer Hospital
Wuhan, Hubei, China
Not Yet Recruiting
20
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
21
The First Affiliated Hospital of Xiamen University
Xiamen, Hujian, China
Not Yet Recruiting
22
Hunan Cancer Hospital
Changsha, Hunan, China
Not Yet Recruiting
23
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
24
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Not Yet Recruiting
25
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Not Yet Recruiting
26
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Not Yet Recruiting
27
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Not Yet Recruiting
28
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
29
The First Hospital of Jilin University
Jilin City, Jilin, China
Not Yet Recruiting
30
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Not Yet Recruiting
31
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Not Yet Recruiting
32
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Not Yet Recruiting
33
Linyi Cancer Hospital
Linyi, Shandong, China
Not Yet Recruiting
34
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
35
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
36
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
37
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
38
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
39
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
40
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
41
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
Y
Yuankai Shi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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