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

Trial Profile

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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top