Clinical Trial: The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.
Brief Summary: This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.
Detailed Summary:
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.
Sponsor: Henan Cancer Hospital
Current Primary Outcome: safety as assessed by the occurrence of study related adverse events. [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome: Same as current
Information By: Henan Cancer Hospital
Dates:
Date Received: September 29, 2016
Date Started: September 2016
Date Completion: July 2019
Last Updated: October 4, 2016
Last Verified: October 2016