The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).
|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: NCT02924753|
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|B-cell Acute Lymphoblastic Leukemia||Drug: Cyclophosphamide Drug: Fludarabine Biological: CART-19 cells||Phase 1|
Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects.
Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.|
|Actual Study Start Date :||July 18, 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).
Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).
Biological: CART-19 cells
CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
Other Name: CD19 specific Chimeric Antigen Receptor T-cells
- safety as assessed by the occurrence of study related adverse events. [ Time Frame: 6 months ]monitor the occurrence of study related adverse events.
- efficacy [ Time Frame: 2 years ]anti-tumor activity of CART-19 cells will be determined in a follow-on study
- duration of CART-19 [ Time Frame: 2 years ]Determine duration of in vivo survival of CART-19 cells.
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): NCT02924753
|Contact: Yongping Songemail@example.com|
|Henan Cancer Hospital||Recruiting|
|Zhengzhou, Henan, China|
|Contact: Yongping Song firstname.lastname@example.org|
|Study Director:||Yongping Song||Henan Cancer Hospital|