Ponatinib as first-line treatment for patients with chronic myeloid leukaemia in chronic phase: a phase 2 study.

ABSTRACT:

Background

Ponatinib has shown efficacy in patients with refractory chronic myeloid leukaemia (CML) and in those with CML with a Thr315Ile mutation. We aimed to investigate the activity and safety of ponatinib as first-line treatment for patients with chronic-phase CML.

Methods

We did a single-arm, phase 2 trial at MD Anderson Cancer Center in Houston, TX, USA. Between May 3, 2012, and Sept 24, 2013, we enrolled patients with early (<6 months) chronic-phase CML and treated them with oral ponatinib once a day. Patients enrolled before July 25, 2013, were given a starting dose of 45 mg per day; we lowered this due to tolerability issues and patients enrolled after this date were given a starting dose of 30 mg per day. After a warning by the US Food and Drug Administration (FDA

SUBMITTER: Jain P 

PROVIDER: S-EPMC4587395 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature