A Phase II Study of Tisagenlecleucel in Pediatric Patients with B-Cell Non-Hodgkin Lymphoma

Full Title

A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Safety and Efficacy of Tisagenlecleucel in Pediatric Patients with Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma (NHL) (BIANCA) (CAR-T)

Purpose

The purpose of this study is to assess the safety and effectiveness of CAR T-cell therapy with tisagenlecleucel in children and teens with B-cell non-Hodgkin lymphoma (NHL). This treatment is already used in children and young adults with acute lymphoblastic leukemia and adults with recurrent or persistent large B-cell lymphoma, but its use patients under age 18 with recurrent or persistent B-cell NHL is considered investigational.

With CAR T-cell therapy, white blood cells called T cells are removed from the patient, altered in the laboratory to recognize a protein on the patient’s cancer cells, multiplied to larger numbers, and returned to the patient to find and destroy cancer cells. The treatment made from the modified T cells is tisagenlecleucel. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have B-cell NHL that continues to grow or came back despite prior treatment.
  • Patients may not have received prior therapy that targets the CD-19 protein or prior CAR T-cell therapy.
  • Patients should recover from the serious side effects of previous treatments before entering the study.
  • This study is for patients under age 18.

For more information about this study and to inquire about eligibility, please contact Dr. Kevin J. Curran at 212-639-5836.

Protocol

19-078

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators