Clinical Trial in Chinese Patients of B-cell Non-Hodgkin's Lymphoma(GB226)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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.
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): 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|