drugset / Trial / NCT02167360

Study of Efficacy and Safety of CTL019 in Adult ALL Patients

NCT02167360

Treatment

Summary

This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with r/r B-cell ALL. The study will have the following sequential phases: Screening, Pre-Treatment, Treatment and Primary Follow-up, Secondary Follow-up (Relapse Follow-up) and Survival Follow-up. The total duration of the primary follow-up is 1 year from cell infusion. Safety will be assessed until the end of the treatment and primary follow-up phase.

Timeline

Start
2016-06
Primary completion
2017-01-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Tisagenlecleucel Cell therapy 2e+08 cells
Subject Tisagenlecleucel Cell therapy 1e+09 cells