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 Identifier: NCT04225676

Novartis Reference Number: CCTL019BUS03

Last Update: Dec 23, 2020

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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.

Phase 2
Overall status 
Enrollment count 
49 participants
Start date 
Oct 19, 2020
Completion date 
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.

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

United States
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, 60611
United States
Cincinnati Children s Hospital Medical Center Cin. Children's Hosp Med Ctr
Cincinnati, 45229-3039
United States
UT Southwestern Medical Center
Dallas, 75235
United States


Novartis Pharmaceuticals

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