A Study of Rocbrutinib in Participants with Relapse or Refractory Mantle Cell Lymphoma
- Registration Number
- NCT05716087
- Lead Sponsor
- Guangzhou Lupeng Pharmaceutical Company LTD.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 62
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rocbrutinib Rocbrutinib Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method 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. To assess the preliminary anti-tumor activity of Rocbrutinib based on Overall survival (OS) as assessed by investigator and IRC.
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. To assess the preliminary anti-tumor activity of Rocbrutinib based on Duration of response (DOR) as assessed by the Investigator and IRC.
Overall Response Rate Up to 24 Months To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by investigator.
Complete remission rate Up to 24 Months To assess the preliminary anti-tumor activity of Rocbrutinib based on complete remission rate (CR) as assessed by investigator and IRC.
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. To assess the preliminary anti-tumor activity of Rocbrutinib based on Progression Free Survival (PFS) as assessed by investigator and IRC.
Time to Response (TTR) Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months. To assess the preliminary anti-tumor activity of Rocbrutinib based on Time to response (TTR) as assessed by the Investigator and IRC.
Safety Assessment From first dose of study drug to 28 days after last dose of study drug To evaluate the safety of Rocbrutinib by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
Maximum Observed Plasma Concentration (Cmax) Up to 24 hours post dose Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of Rocbrutinib
Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) Up to 24 hours post dose PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) of Rocbrutinib
Maximum Observed Plasma Concentration (Tmax) Up to 24 hours post dose PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of Rocbrutinib
Half-life period (T1/2) Up to 24 hours post dose PK As Assessed By Time To Half-life period (T1/2) Of Rocbrutinib
Quality of life (QoL) Up to 24 Months Quality of life Assessed By the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire (The total score ranges from 30 to126, Items 29 and 30 are scored from 1 to 7 points, and other items are scored from 1 to 4 points. Except for items 29 and 30, the higher value, the worse QoL.)
Trial Locations
- Locations (42)
Beijing Friendship hospital
🇨🇳Beijing, China
Anhui provincial cancer hospital
🇨🇳Hefei, Anhui, China
The first affiliated hospital of Anhui medical university
🇨🇳Hefei, Anhui, China
The first affiliated hospital of Chongqing mediacal university
🇨🇳Chongqing, Chongqing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
The first affiliated hospital of Xiamen university
🇨🇳Xiamen, Fujian, China
Fujian Medical university union hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Gansu provincial cancer hospital
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Meizhou people'shospital
🇨🇳Meizhou, Guangdong, China
Harbin First Hospital
🇨🇳Ha'erbin, Heilongjiang, China
The fourth hospital of Hebei medical university
🇨🇳Shijia Zhuang, Hebei, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Henan provincial people's hospital
🇨🇳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
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Qilu hospital of Shandong university
🇨🇳Jinan, Shandong, China
West China School of Medicine
🇨🇳Chengdu, Sichuan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Tianjin medical university cancer hospital
🇨🇳Tianjin, Tianjin, China
Affiliated hospital of hebei university
🇨🇳Baoding, China
Beijing Boren Hospital
🇨🇳Beijing, China
Sichuan Cancer Hospital
🇨🇳Chengdu, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, China
The First People's Hospital of Foshan
🇨🇳Foshan, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, China
The first affiliated hospital of Wenzhou medical university
🇨🇳Wenzhou, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, China
The first hospital of China medical university
🇨🇳Shenyang, Liaoning, China
The first affiliated hospital of Zhengzhou university
🇨🇳Zhengzhou, Henan, China
Tianjin Hematonosis Hospital
🇨🇳Tianjin, Tianjin, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, China
Hubei Cancer Hospital
🇨🇳Wuhan, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China