Summary

Eligibility
for people ages 2-25 (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

Summary

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.

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

Details

This trial is 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 (ALL) experiencing loss of B cell aplasia. Loss of B-cell aplasia is defined as: peripheral blood (PB) absolute B lymphocyte count ≥ 50/µL, OR PB B lymphocyte ≥ 10% of the total lymphocytes. The study will have the following phases for all patients: Screening, Treatment and Follow-up. The total duration of the study is about 12 months. After tisagenlecleucel re-infusion, efficacy will be assessed at months 1, 3, 6, and 12 at which time blood samples will be obtained to measure circulating B lymphocytes (< 50/µL) and presence of CTL019 cells by qPCR in the peripheral blood. Safety will be assessed throughout the study. The end of the study will be when all patients complete a month 12 visit unless discontinuing prior. The patient may voluntarily withdraw from the study for any reason, at any time. Patients who receive commercial tisagenlecleucel must be followed for up to 15 years post-infusion. Patients can be followed under the Center for International Blood and Marrow Transplant Research (CIBMTR) cellular therapy registry if consented for participation. For patients who do not provide consent for participation in the Center for International Blood and Marrow Transplant Research (CIBMTR) registry, AEs will need to be reported for 15 years or until the patient enrolls in the registry.

Keywords

ALL CTL019 Kymriah Tisagenlecleucel B-Cell Acute Lymphoblastic Leukemia Leukemia Pediatric Young Adult Reinfusion Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid

Eligibility

You can join if…

Open to people ages 2-25

  • 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

You CAN'T join if...

  • 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

Other protocol-defined Inclusion/Exclusion may apply.

Locations

  • Childrens Hospital Los Angeles Divisionof Hematology/Oncology accepting new patients
    Los Angeles California 90027 United States
  • University of Utah Clinical Trials Office accepting new patients
    Salt Lake City Utah 84108 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT04225676
Phase
Phase 2
Study Type
Interventional
Last Updated