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

Trial ID or NCT#

NCT04225676

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 2 Years to 25 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Signed informed consent must be obtained prior to participation in the study - Must have an additional dose of unexpired, commercial 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:
  1. - 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

Investigator(s)

Kara Davis

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Contact

mikekunicki@stanford.edu
650-736-0555