drugset
drugset / Trial / NCT04156659

Study of Tisagenlecleucel in Chinese Pediatric and Young Adult Subjects With Relapsed or Refractory B-cell ALL

NCT04156659 ↗

Phase 2 Withdrawn Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This is a single arm, multi-center, phase II study to evaluate the efficacy and safety of tisagenlecleucel in Chinese pediatric and young adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL)

Timeline

Start
2021-11-30
Primary completion
2022-11-30
Completion
2027-11-30

Drugs

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

Indications

B-cell acute lymphoblastic leukemia