A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 12 Jan 2018
At a glance
- Drugs Dasatinib (Primary) ; Dasatinib (Primary)
- Indications Acute lymphoblastic leukaemia; Chronic myeloid leukaemia
- Focus Therapeutic Use
- Sponsors Bristol-Myers Squibb
- 10 Nov 2017 According to a Bristol-Myers Squibb media release, based on the data from this trial, the U.S. FDA has approved dasatinib (Sprycel) for the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
- 23 Aug 2017 Planned End Date changed from 1 Sep 2018 to 23 Sep 2021.
- 10 Jul 2017 According to a Bristol-Myers Squibb media release, based on the data from this trial, the U.S. FDA has accepted supplemental New Drug Application (sNDA) to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension (PFOS) formulation of Sprycel. The application is under priority review with an action date of November 9, 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History