A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia
Phase of Trial: Phase II
Latest Information Update: 03 Oct 2017
At a glance
- Drugs Tisagenlecleucel-T (Primary)
- Indications Acute lymphoblastic leukaemia; B cell lymphoma
- Focus Registrational; Therapeutic Use
- Acronyms ELIANA
- Sponsors Novartis; Novartis Pharmaceuticals
- 30 Aug 2017 According to a Novartis media release, the US FDA has approved CTL019 (tisagenlecleucel) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. The FDA approval is based on the results of this trial.
- 24 Jul 2017 Planned End Date changed from 1 Jan 2023 to 3 Mar 2022.
- 24 Jul 2017 Planned primary completion date changed from 1 Jan 2023 to 15 Dec 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History