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Active, not recruiting Phase 2

A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma

NCT05716087 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2023-02-21
Last updated
2026-01-15

Condition(s) studied

Mantle Cell Lymphoma (MCL)

Investigational drug(s) / intervention(s)

Rocbrutinib →

Rocbrutinib: Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL. 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: 1. Received non-covalent BTK inhibitor treatment. 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.

Primary outcome measure(s)

  • Overall Response Rate — Up to 24 Months
    To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).

Trial sites (43)

FacilityCityRegionStatus
Anhui provincial cancer hospital Hefei Anhui
The first affiliated hospital of Anhui medical university Hefei Anhui
Peking University Third Hospital Beijing Beijing Municipality
Beijing Cancer Hospital Beijing Beijing Municipality
The first affiliated hospital of Chongqing mediacal university Chongqing Chongqing Municipality
Fujian Cancer Hospital Fuzhou Fujian
Fujian Medical university union hospital Fuzhou Fujian
The first affiliated hospital of Xiamen university Xiamen Fujian
Gansu provincial cancer hospital Lanzhou Gansu
Sun Yat-sen University Cancer Center Guangzhou Guangdong
Meizhou people'shospital Meizhou Guangdong
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
The fourth hospital of Hebei medical university Shijiazhuang Hebei
Harbin First Hospital Harbin Heilongjiang
The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan
Henan Cancer Hospital Zhengzhou Henan
Henan provincial people's hospital Zhengzhou Henan
The first affiliated hospital of Zhengzhou university Zhengzhou Henan
Hunan cancer hospital Changsha Hunan
Jiangsu cancer hospital Nanjing Jiangsu
Jiangsu province hospital Nanjing Jiangsu
The first affiliated hospital of Nanchang university Nanchang Jiangxi
The second hospital of dalian medical university Dalian Liaoning
Shengjing hospital of China medical university Shenyang Liaoning
The first hospital of China medical university Shenyang Liaoning
Qilu hospital of Shandong university Jinan Shandong
Shandong Cancer Hospital Jinan Shandong
West China School of Medicine Chengdu Sichuan
Tianjin Hematonosis Hospital Tianjin Tianjin Municipality
Tianjin medical university cancer hospital Tianjin Tianjin Municipality
Zhejiang Cancer Hospital Hangzhou Zhejiang
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

+ 3 more sites — see the full list on the official registry below.

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 NCT05716087 on ClinicalTrials.gov ↗ ← All trials in China