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 ]

monitor the occurrence of study related adverse events.


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