A Phase II, Single Arm, Open Label Study of Treatment-Free Remission in Chronic Myeloid Leukemia (CML) chronic phase (CP) patients After Achieving Sustained MR4.5 on Nilotinib.
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 28 Sep 2017
At a glance
- Drugs Nilotinib (Primary)
- Indications Chronic myeloid leukaemia
- Focus Therapeutic Use
- Acronyms ENESTop; MACS1940
- Sponsors Novartis Pharmaceuticals
- 25 Jun 2017 Results (data cutoff, 7 Nov 2016) assessing the proportion of patients remaining in treatment-free-remission at 96 week, presented at the 22nd Congress of the European Haematology Association
- 23 Jun 2017 According to a Novartis media release, this study is ongoing with planned follow-up to evaluate the ability of patients to sustain remission for longer durations following discontinuation of Tasigna.
- 23 Jun 2017 According to a Novartis media release, the decision to add TFR data to the Tasigna SmPC is applicable to all 28 EU member states plus Iceland and Norway.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History