BTK Inhibitor BGB-3111 in Chinese Patients With Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)
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|ClinicalTrials.gov Identifier: NCT03520920|
Recruitment Status : Active, not recruiting
First Posted : May 10, 2018
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Marginal Zone Lymphoma Follicular Lymphoma Diffuse Large B-Cell Lymphoma||Drug: BGB-3111||Phase 2|
This is a multicenter open-label phase 2 study to evaluate efficacy, safety and tolerability of BGB-3111 160 mg twice daily in combination with rituximab in Chinese Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (non-GCB Subtype) and Relapsed/Refractory Indolent Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma）.
The study is composed of two cohorts. Cohort 1 will be approximately 20 subjects and Cohort 2 will be approximately 20 subjects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study to Assess the Safety, Tolerability, and Activity of BGB-3111 in Combination With Rituximab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and R/R Indolent Lymphoma|
|Actual Study Start Date :||January 4, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: cohort 1 and cohort 2
BGB-3111 in combination with Rituximab in relapsed/refractory non-GCB DLBCL and relapsed/refractory follicular (FL) or marginal zone lymphoma (MZL)
Other Name: Rituximab
- overall response rate（ORR） [ Time Frame: up to 2 years ]The achievement of either a partial response (PR) or complete response (CR)
- Progression free survival (PFS) [ Time Frame: up to 2 years ]Defined as time from first dose of BGB-3111 until first documentation of Progression (by IWG on NHL criteria) or death, whichever comes first
- Duration of response (DOR) [ Time Frame: up to 2 years ]Defined as the time from the date that the response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
- Overall survival (OS) [ Time Frame: up to 2 years ]Defined as the time from first dose of BGB-3111 until death.
- Time to response (TTR) [ Time Frame: up to 2 years ]Defined as the time from first dose of BGB-3111 to documentation of a response.
- Rate of complete response or complete metabolic response [ Time Frame: up to 2 years ]Defined as the time from first dose of BGB-3111 to complete response or complete metabolic response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520920
|Harbin Medical University Cancer Hospital|
|Harbin, Heilongjiang, China|
|Tongji Hospital, Tongji Medical college of HUST|
|Wuhan, Hubei, China|
|The Affiliated Hospital of Xuzhou Medical University|
|Xuzhou, Jiangsu, China|
|Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Mdicine|
|Shanghai, Shanghai, China|
|Principal Investigator:||Jianfeng Zhou, Doctor||Tongji Hospital|