CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03984968|
Recruitment Status : Enrolling by invitation
First Posted : June 13, 2019
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia, Adult B-Cell||Biological: CAR-T infusion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Safety and Efficacy of CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia Concomitant With Infusion of CD19+T Cells as Feeding Cells|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: CAR-T infusion
CAR-T cells and feeding T cells were infused into remission patients sequentially,with 5*10e6/kg and 1*10e7/kg respectively for each cycle. Each patient underwent 3 cyles of CAR-T consolidation therapies and was followed up for 2 years.
Biological: CAR-T infusion
Patients enrolled in this arm will receive CAR-T infusion
- Overall survial [ Time Frame: 2 year ]It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
- Event free survival [ Time Frame: 2 year ]It is measured from the date of entry into this trial to the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.
- Hypocytosis [ Time Frame: 6 months ]Events of Hypocytosis after CAR-T infusion
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): NCT03984968
|The First Affliated Hospital of Soochow University|
|Suzhou, Jiangsu, China, 215006|