Clinical Trial in Chinese Patients of B-cell Non-Hodgkin's Lymphoma(GB226)
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|ClinicalTrials.gov Identifier: NCT03639181|
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : December 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|B-cell Non-Hodgkin's Lymphoma||Biological: GB226||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Efficacy and Safety of Genormab Injection in Chinese Patients With Recurrent or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)|
|Actual Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: GB226 3mg/kg every 2 weeks
Geptanolimab Injection, 3mg/kg every 2 weeks
3mg/kg treat every 2 weeks
Other Name: Geptanolimab Injection
- Objective Response Rate, ORR [ Time Frame: up to 52 weeks ]To evaluate the efficacy of GB226 as defined by objective response rate, in patients with B-NHL.
- Duration of response, DOR [ Time Frame: up to 52 weeks ]To evaluate the duration of response (DOR) of GB242 in patients with B-NHL.
- Overall survival, OS [ Time Frame: up to 52 weeks ]To evaluate the duration from the first administration to death because of any reason in patients with B-NHL.
- Progression-free survival, PFS [ Time Frame: up to 52 weeks ]To evaluate the efficacy of GB226 as defined by progression-free survival, in patients with B-NHL.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639181
|Contact: Shawn Yu, Masteremail@example.com|
|Cancer Hospital Chinese Academy of Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: Yuankai Shi, Doctor|
|Principal Investigator: Yuankai Shi, Doctor|
|Principal Investigator:||Yuankai Shi, Doctor||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|