A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma
An Open Label, Single Arm, Multicenter Phase II Study of the Efficacy and Safety of Rocbrutinib Monotherapy for Recurrent or Refractory Mantle Cell Lymphoma
1 other identifier
interventional
62
1 country
43
Brief Summary
This is an open-label, single arm, multi-center Phase 2 study of oral Rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2023
Typical duration for phase_2
43 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
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedStudy Start
First participant enrolled
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedJanuary 15, 2026
January 1, 2026
1.8 years
January 19, 2023
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
Up to 24 Months
Secondary Outcomes (12)
Overall Response Rate
Up to 24 Months
Complete remission rate
Up to 24 Months
Progression Free Survival
Measured from the date of first dose of study drug to the date of earliest disease progression or death or last visit, and assessed 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)
Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.
- +7 more secondary outcomes
Study Arms (1)
Rocbrutinib
EXPERIMENTALSubjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated
Interventions
Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.
Eligibility Criteria
You may qualify if:
- Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL.
- At least one measurable lesion.
- Subjects who have previously received the treatment regimen containing anti-CD20 and at least one BTKi treatment failed or relapsed after remission or intolerated; Or Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-CD20.
- ECOG≤2.
- Adequate hematologic function.
- Adequate hepatic and renal function.
- Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \[and 2 years of non-therapy-induced amenorrhea\] or surgically sterile) to observe conventional and effective birth control.
You may not qualify if:
- Received non-covalent BTK inhibitor treatment.
- Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of Rocbrutinib: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.
- Subjects who have received the following treatments within 2 weeks before the first dose of Rocbrutinib: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.
- Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.
- Disease affects the central nervous system.
- Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Anhui provincial cancer hospital
Hefei, Anhui, China
The first affiliated hospital of Anhui medical university
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100089, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
The first affiliated hospital of Chongqing mediacal university
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Medical university union hospital
Fuzhou, Fujian, China
The first affiliated hospital of Xiamen university
Xiamen, Fujian, China
Gansu provincial cancer hospital
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Meizhou people'shospital
Meizhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The fourth hospital of Hebei medical university
Shijiazhuang, Hebei, China
Harbin First Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science & 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
Hunan cancer hospital
Changsha, Hunan, China
Jiangsu cancer hospital
Nanjing, Jiangsu, China
Jiangsu province hospital
Nanjing, Jiangsu, China
The first affiliated hospital of Nanchang university
Nanchang, Jiangxi, China
The second hospital of dalian medical university
Dalian, Liaoning, China
Shengjing hospital of China medical university
Shenyang, Liaoning, China
The first hospital of China medical university
Shenyang, Liaoning, China
Qilu hospital of Shandong university
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
West China School of Medicine
Chengdu, Sichuan, China
Tianjin Hematonosis Hospital
Tianjin, Tianjin Municipality, China
Tianjin medical university cancer hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Affiliated hospital of hebei university
Baoding, China
Beijing Boren Hospital
Beijing, China
Beijing Friendship hospital
Beijing, China
The First Bethune Hospital of Jilin University
Changchun, China
Sichuan Cancer Hospital
Chengdu, China
The First People's Hospital of Foshan
Foshan, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Sun Yat-sen Memorial Hospital
Guangzhou, China
The First Affiliated Hospital of Soochow University
Suzhou, China
The first affiliated hospital of Wenzhou medical university
Wenzhou, China
Hubei Cancer Hospital
Wuhan, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jun Zhu, MD, PhD
Peking University Cancer Hospital & Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2023
First Posted
February 8, 2023
Study Start
February 21, 2023
Primary Completion
December 5, 2024
Study Completion (Estimated)
June 30, 2026
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share