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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.
Overall Response Rate
To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
Time frame: Up to 24 Months
Overall Response Rate
To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by investigator.
Time frame: Up to 24 Months
Complete remission rate
To assess the preliminary anti-tumor activity of Rocbrutinib based on complete remission rate (CR) as assessed by investigator and IRC.
Time frame: Up to 24 Months
Progression Free Survival
To assess the preliminary anti-tumor activity of Rocbrutinib based on Progression Free Survival (PFS) as assessed by investigator and IRC.
Time frame: 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.
Overall survival
To assess the preliminary anti-tumor activity of Rocbrutinib based on Overall survival (OS) as assessed by investigator and IRC.
Time frame: 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.
Duration of Response (DOR)
To assess the preliminary anti-tumor activity of Rocbrutinib based on Duration of response (DOR) as assessed by the Investigator and IRC.
Time frame: Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.
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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
...and 33 more locations
Time to Response (TTR)
To assess the preliminary anti-tumor activity of Rocbrutinib based on Time to response (TTR) as assessed by the Investigator and IRC.
Time frame: Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.
Safety Assessment
To evaluate the safety of Rocbrutinib by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
Time frame: From first dose of study drug to 28 days after last dose of study drug
Maximum Observed Plasma Concentration (Cmax)
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of Rocbrutinib
Time frame: Up to 24 hours post dose
Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t)
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
Time frame: Up to 24 hours post dose
Maximum Observed Plasma Concentration (Tmax)
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of Rocbrutinib
Time frame: Up to 24 hours post dose
Half-life period (T1/2)
PK As Assessed By Time To Half-life period (T1/2) Of Rocbrutinib
Time frame: Up to 24 hours post dose
Quality of life (QoL)
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.)
Time frame: Up to 24 Months