drugset / Trial / NCT04225676

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

NCT04225676

Phase 2 Terminated 5 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-10-19
Primary completion
2021-10-19
Completion
2021-10-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Tisagenlecleucel Cell therapy 200000 cells/kg
Subject Tisagenlecleucel Cell therapy 5e+06 cells/kg
Subject Tisagenlecleucel Cell therapy 1e+07 cells
Subject Tisagenlecleucel Cell therapy 2.5e+08 cells