This is an open-label, randomized controlled, multicenter Phase II clinical study primarily evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR/R2 regimen in patients with non-GCB DLBCL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc.
Participants will receive a total of 6 cycles (a cycle being 28 days) 90 mg/m2 Bendamustine (IV infusion) on Days 1 and 2 of Cycles 1-6.
Participants will receive a total of 6 cycles (a cycle being 28 days) of 375 mg/m2 Rituximab (IV infusion) on Day 1 of each cycle.
Overall Response Rate
To assess the anti-tumor activity of Rocbrutinib and BR/R2 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 and BR/R2 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 and BR/R2 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 and BR/R2 based on Progression Free Survival (PFS) as assessed by investigator and IRC.
Time frame: Up to 24 months
Overall survival
To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 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 and BR/R2 based on Duration of response (DOR) as assessed by the Investigator and IRC.
Time frame: Up to 24 months
Time to Response (TTR)
To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Time to response (TTR) as assessed by the Investigator and IRC.
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20mg qd PO day 1-21
Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital)
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Shijitan Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Tongren Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGNational Cancer Center/Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGAffiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGNanfang Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITING...and 31 more locations
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 and BR/R2 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