Trial Title:
A Study of Rocbrutinib in Participants with Relapse or Refractory Mantle Cell Lymphoma
NCT ID:
NCT05716087
Condition:
Mantle Cell Lymphoma (MCL)
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Rocbrutinib
Description:
Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once
daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.
Arm group label:
Rocbrutinib
Other name:
NWP-775
Other name:
LP-168
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui provincial cancer hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Kaiyang Ding
Facility:
Name:
The first affiliated hospital of Anhui medical university
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingshu Zeng
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100089
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Jing, M.D.
Phone:
+861082265531
Email:
hongmei_jing@163.com
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuqin Song
Phone:
+861088196596
Email:
SongYQ_VIP@163.com
Facility:
Name:
The first affiliated hospital of Chongqing mediacal university
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoqiong Tang
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Yang
Facility:
Name:
Fujian Medical university union hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianzhen Shen
Facility:
Name:
The first affiliated hospital of Xiamen university
Address:
City:
Xiamen
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhifeng Li
Facility:
Name:
Gansu provincial cancer hospital
Address:
City:
Lanzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Cui
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingqing Cai, M.D.
Phone:
+862087342823
Email:
caiqq@sysucc.org.cn
Facility:
Name:
Meizhou people'shospital
Address:
City:
Meizhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Guowu Wu
Facility:
Name:
The First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhigang Peng
Facility:
Name:
The fourth hospital of Hebei medical university
Address:
City:
Shijia Zhuang
Country:
China
Status:
Recruiting
Contact:
Last name:
Lihong Liu
Facility:
Name:
Harbin First Hospital
Address:
City:
Ha'erbin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jun Ma
Facility:
Name:
The First Affiliated Hospital of Henan University of Science & Technology
Address:
City:
Luoyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Haiping Yang
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Keshu Zhou
Facility:
Name:
Henan provincial people's hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zunmin Zhu
Facility:
Name:
The first affiliated hospital of Zhengzhou university
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Zhang
Facility:
Name:
Hunan cancer hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Zhou
Facility:
Name:
Jiangsu cancer hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yufei Liu
Facility:
Name:
Jiangsu province hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Xu
Facility:
Name:
The first affiliated hospital of Nanchang university
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Li
Facility:
Name:
The second hospital of dalian medical university
Address:
City:
Dalian
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiuhua Sun
Facility:
Name:
Shengjing hospital of China medical university
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Yang
Facility:
Name:
The first hospital of China medical university
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojing Yan
Facility:
Name:
Qilu hospital of Shandong university
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunyan Ji
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zengjun Li
Facility:
Name:
West China School of Medicine
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Jiang
Facility:
Name:
Tianjin Hematonosis Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuhua Yi
Facility:
Name:
Tianjin medical university cancer hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Lanfang Li
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiyan Yang
Facility:
Name:
Affiliated hospital of hebei university
Address:
City:
Baoding
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Youchao Jia
Facility:
Name:
Beijing Boren Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Kai Hu
Facility:
Name:
Beijing Friendship hospital
Address:
City:
Beijing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhao Wang
Facility:
Name:
The First Bethune Hospital of Jilin University
Address:
City:
Changchun
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ou Bai
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhihui Zhang
Facility:
Name:
The First People's Hospital of Foshan
Address:
City:
Foshan
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Zhao
Facility:
Name:
Nanfang Hospital, Southern Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaolei Wei
Facility:
Name:
Sun Yat-sen Memorial Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yudan Wu
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengming Jin
Facility:
Name:
The first affiliated hospital of Wenzhou medical university
Address:
City:
Wenzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Kang Yu
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Huijing Wu
Facility:
Name:
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Gaoxiang Wang
Start date:
February 21, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Guangzhou Lupeng Pharmaceutical Company LTD.
Agency class:
Industry
Source:
Guangzhou Lupeng Pharmaceutical Company LTD.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05716087
