Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Biological: Tisagenlecleucel

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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:

   - 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

Ages Eligible for Study

2 Years - 25 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
mikekunicki@stanford.edu
650-736-0555
Not Recruiting