Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT03258047|
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : February 8, 2018
It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.
Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
|Condition or disease||Intervention/treatment||Phase|
|B Cell Lymphoma||Combination Product: CAR-T||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||July 30, 2019|
Experimental: CAR-T treatment
In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated
Combination Product: CAR-T
CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.
- complete remission rate [ Time Frame: every 3 months until 20 months after the last patient's enrollment ]complete remission rate after treated by CAR-T therapy
- progression free survival [ Time Frame: from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment ]from date of inclusion to date of progression, relapse, or death from any cause
- overall survival [ Time Frame: 20 months after the last patient's enrollment ]from the date of inclusion to date of death, irrespective of cause
- adverse events [ Time Frame: from the date of the start of treatment to 20 months after last patient's enrollment ]any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
- duration of the modified T cells by CAR-T in the patients [ Time Frame: from the date of re-transfusison to 20 months after last patient's enrollment ]time from re-transfusion to date when the modified T cells become non-detectable.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258047
|Contact: Wenbin Qian, MD,PhD||(+86)email@example.com|
|Contact: Hui Liu, MD，PhD||(+86)13819198629|
|The first affiliated hospital of Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 310000|
|Contact: Wenbin Qian, MD. PhD. (+86)13605801032|