Clinical trial NCT05716087: A Study of Rocbrutinib in Participants with Relapse or Refractory Mantle Cell Lymphoma
Official title: An Open Label, Single Arm, Multicenter Phase II Study of the Efficacy and Safety of Rocbrutinib Monotherapy for Recurrent or Refractory Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Mantle Cell Lymphoma (MCL)
Lead sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Overall Response Rate
timeFrame: Up to 24 Months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 24 Months
measure: Complete remission rate
timeFrame: Up to 24 Months
measure: Progression Free Survival
timeFrame: 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.
measure: Overall survival
timeFrame: 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.
measure: Duration of Response (DOR)
timeFrame: Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.
measure: Time to Response (TTR)
timeFrame: Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.
measure: Safety Assessment
timeFrame: From first dose of study drug to 28 days after last dose of study drug
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 24 hours post dose
measure: Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t)
timeFrame: Up to 24 hours post dose
measure: Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to 24 hours post dose
measure: Half-life period (T1/2)
timeFrame: Up to 24 hours post dose
measure: Quality of life (QoL)
timeFrame: Up to 24 Months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui provincial cancer hospital
state: Anhui
city: Hefei
country: China
facility: The first affiliated hospital of Anhui medical university
state: Anhui
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: The first affiliated hospital of Chongqing mediacal university
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Medical university union hospital
state: Fujian
city: Xiamen
country: China
facility: The first affiliated hospital of Xiamen university
state: Fujian
city: Lanzhou
country: China
facility: Gansu provincial cancer hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Meizhou
country: China
facility: Meizhou people'shospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shijia Zhuang
country: China
facility: The fourth hospital of Hebei medical university
state: Hebei
city: Ha'erbin
country: China
facility: Harbin First Hospital
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan provincial people's hospital
state: Henan
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou university
state: Henan
city: Changsha
country: China
facility: Hunan cancer hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu cancer hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu province hospital
state: Jiangsu
city: Nanchang
country: China
facility: The first affiliated hospital of Nanchang university
state: Jiangxi
city: Dalian
country: China
facility: The second hospital of dalian medical university
state: Liaoning
city: Shenyang
country: China
facility: Shengjing hospital of China medical university
state: Liaoning
city: Shenyang
country: China
facility: The first hospital of China medical university
state: Liaoning
city: Jinan
country: China
facility: Qilu hospital of Shandong university
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Chengdu
country: China
facility: West China School of Medicine
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Hematonosis Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin medical university cancer hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Baoding
country: China
facility: Affiliated hospital of hebei university
city: Beijing
country: China
facility: Beijing Boren Hospital
city: Beijing
country: China
facility: Beijing Friendship hospital
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Wenzhou
country: China
facility: The first affiliated hospital of Wenzhou medical university
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu, MD, PhD
role: STUDY_CHAIR
References: