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
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Oct 19, 2020
Oct 21, 2020
Oct 27, 2022
25 Years and older (Child, Adult)
Tisagenlecleucel Cell Dispersion for Infusion given once during the study.
The approved dose range for tisagenlecleucel is: 0.2 to 5.0×106 CAR positive viable T cells / kg for patients' ≤ 50 kg body weight or 0.1 to 2.5×108 CAR-positive viable T cells for patients > 50 kg body weight.
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
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.