Study of Efficacy and Safety of Tisagenlecleucel in High Risk (HR) B-cell Acute Lymphoblastic Leukemia (ALL) Who Are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy (CASSIOIPEIA)


Age Group
0-9 years 10-17 years 18-26 years


Biological treatment cell Biological
Trial Summary & Details
Ages: 1 Year to 25 Years(Child, Adult)
Condition: B-Cell Acute Lymphoblastic Leukemia

This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment & follow-up, and survival. After tisagenlecleucel infusion, efficacy will be assessed at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Safety will be assessed throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up for lentiviral vector safety will continue under a separate protocol per health authority guidelines. (AALL1721/ CCTL019G2201J)

Johns Hopkins, Baltimore, MD
The Childrens Hospital of Philadelphia (CHOP), Philadelphia, PA
University of Texas Southwestern Medical Center, Dallas, TX
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Copenhagen, Denmark
Novartis Investigative Site, Paris Cedex 19, France
Novartis Investigative Site, Roma, Italy
Novartis Investigative Site, Oslo, Norway
Novartis Investigative Site, Esplugues de Llobregat, Barcelona, Spain

Novartis Pharmaceuticals
Children's Oncology Group
Novartis Pharmaceuticals