Gene Therapy Clinical Trials
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.
Stanford Investigator(s):
Intervention(s):
- biological: Tisagenlecleucel
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