A Study of Rocbrutinib in Participants with Relapse or Refractory Mantle Cell Lymphoma
NCT ID: NCT05716087
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
62 participants
INTERVENTIONAL
2023-02-21
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rocbrutinib
Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated
Rocbrutinib
Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.
Interventions
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Rocbrutinib
Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least one measurable lesion.
3. 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.
4. ECOG≤2.
5. Adequate hematologic function.
6. Adequate hepatic and renal function.
7. 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.
Exclusion Criteria
2. 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.
3. 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.
4. Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections.
5. Disease affects the central nervous system.
6. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
18 Years
ALL
No
Sponsors
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Guangzhou Lupeng Pharmaceutical Company LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Jun Zhu, MD, PhD
Role: STUDY_CHAIR
Peking University Cancer Hospital & Institute
Locations
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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, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 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, 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
Countries
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Other Identifiers
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LP-168-CN201
Identifier Type: -
Identifier Source: org_study_id