A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or accelerated phase (AP) resistant or intolerant to either imatinib or dasatinib
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 01 Dec 2017
At a glance
- Drugs Nilotinib (Primary)
- Indications Chronic myeloid leukaemia
- Focus Therapeutic Use
- Acronyms DIALOGUE 1
- Sponsors Novartis Pharmaceuticals
- 20 Nov 2017 Results published in the Novartis Media Release.
- 20 Nov 2017 According to a Novartis media release, based on the results from this trial, the European Commission (EC) approved Tasigna (nilotinib) for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) and pediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy.
- 05 Jul 2017 Status changed from recruiting to active, no longer recruiting.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History