This study aims to evaluate the safety and feasibility of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Hôpital Robert-Debré
Paris, France
Incidence and Severity of Adverse Events
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: From inclusion to Month 12
Molecular Remission Rate
Proportion of patients in whom a molecular Complete Remission (CR) or a Complete Remission with incomplete blood recovery (CRi) is observed (i.e. a CR or CRi combined to a Minimal residual disease \<10-4).
Time frame: At Day 28 after the first UCART19 infusion
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Hospital San Juan De Dios
Barcelona, Spain
UCL Great Ormond Hospital
London, United Kingdom