Study of CAR T Cell Therapy Using Fludarabine and Cyclophosphamide Chemotherapy in Children and Young Adults With CD19-Positive Leukemia

What this Trial Is About

Researchers are evaluating a treatment approach for children, adolescents, and young adults aged 21 years or younger who have relapsed or refractory CD19-positive acute lymphoblastic leukemia. This Phase II study aims to assess different doses of the chemotherapy drug fludarabine before infusion of CAR T cell therapy, how the body processes the chemotherapy drugs fludarabine and cyclophosphamide, the persistence of CAR T cells in the body, treatment effectiveness, and potential side effects. The treatment involves two main phases. First, blood cells are collected through apheresis and modified in a lab to better recognize and attack leukemia cells, creating CD19-CAR T cells. Next, patients receive lymphodepleting chemotherapy with age-based dosing of fludarabine and cyclophosphamide. This is followed by a single infusion of the modified CAR T cells given intravenously, dosed at 3 million CAR T cells per kilogram of body weight. The study includes a two-part consent process covering cell collection and treatment phases. Participants will undergo assessments including monitoring of fludarabine levels on days before CAR T cell infusion and evaluations of heart, kidney, and lung function. Researchers will track how long the CAR T cells remain in the body and watch for side effects. The study involves regular clinical evaluations, laboratory tests, and performance scoring to ensure patient safety and measure treatment impact. Participation lasts through treatment and follow-up periods as defined by the protocol.

CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia