drugset / Trial / NCT02167360
Study of Efficacy and Safety of CTL019 in Adult ALL Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tisagenlecleucel | Cell therapy | 2e+08 cells | — |
| Subject | Tisagenlecleucel | Cell therapy | 1e+09 cells | — |