A Phase II Study of CAR T-Cell Therapy in Children and Young Adults with High-Risk B-Cell Acute Lymphoblastic Leukemia with Minimal Residual Disease after Chemotherapy

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Full Title

A Phase II Trial of Tisagenlecleucel in First-Line High-Risk (HR) Pediatric and Young Adult Patients with B-cell Acute Lymphoblastic Leukemia (B-ALL) Who are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy (CAR-T)

Purpose

CAR T-cell therapy with tisagenlecleucel has been approved by the U.S. Food and Drug Administration to treat children and young adults with recurrent or persistent acute lymphoblastic leukemia (ALL). In this study, researchers want to determine its safety and effectiveness in children and young adults with high-risk B-cell ALL who have small numbers of cancer cells remaining in the body after treatment with chemotherapy (a condition called “minimal residual disease”).

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 high-risk CD19-positive B-cell ALL with minimal residual disease after consolidation chemotherapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 1-25 years.

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

Protocol

19-375

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators