CCTL019BUS03: Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)

Why are we doing this research?

This is a multi-center Phase II study investigating the efficacy and safety of reinfusion of tisagenlecleucel in pediatric and young adult patients with ALL who were treated with tisagenlecleucel and experience B cell recovery.

CCTL019BUS03: A Phase II, Open Label, Multi-center Trial to Determine the Efficacy and Safety of Tisagenlecleucel Re-infusion in Pediatric and Adolescent Young Adult (AYA) Patients With Acute Lymphoblastic Leukemia Experiencing Loss of B Cell Aplasia

Who can participate?

Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study
  • Must have an additional dose of tisagenlecleucel available and prescribed by a physician in the course of medical practice
  • Age up to and including 25 years
  • Patients must have CD-19+ Leukemia
  • Patients who were previously treated with tisagenlecleucel and present with evidence of B-cell recovery as defined by: Peripheral blood (PB) absolute B lymphocyte count ≥ 50/µL, OR PB B lymphocyte ≥ 10% of the total lymphocytes

Exclusion Criteria:

  • Prior gene therapy other than tisagenlecleucel
  • Prior adoptive T cell therapy other than tisagenlecleucel
  • Active CNS involvement by malignancy
  • Active or latent hepatitis B or active hepatitis C, or any uncontrolled infection at screening
  • HIV positive test within 8 weeks of screening


  • up to 25 Years


  • Leukemia ALL New Diagnosis
  • Adult - Leukemia ALL New Diagnosis


Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799