Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)
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
ClinicalTrials.gov Identifier: NCT04225676
Novartis Reference Number: CCTL019BUS03
Last Update: Mar 30, 2021
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.
Study Description
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.
Interventions
Eligibility Criteria
Inclusion Criteria:
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
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
Other protocol-defined Inclusion/Exclusion may apply.
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]