To better characterize the long-term safety of ruxolitinib (INC424)

• Research type

  Research Study

• Full title

  An open label, multi-center, Phase IV rollover protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study or ruxolitinib and panobinostat (LBH589) combination study, and are judged by the investigator to benefit from continued treatment

• IRAS ID

  261309

• Contact name

  Claire Harrison

• Contact email

  claire.harrison@gstt.nhs.uk

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2014-003527-22

• Clinicaltrials.gov Identifier

  NCT02386800

• Duration of Study in the UK

  5 years, 8 months, 1 days

• Research summary

  This is a Phase IV, multi-centre rollover study to allow continued access to ruxolitinib or a combination of ruxolitinib and panobinostat for patients who have participated in other Novartis studies and judged by their doctor to be benefiting from treatment. The study aims to evaluate the long term safety data of patients taking ruxolitinib or a combination of ruxolitinib and panobinostat. Eligible patients with primary myelofibrosis (PMF), post-polycythemia veramyelofibrosis (PPV-MF), post-essential thrombocythemia-myelofibrosis (PET-MF) or Steroid-Refractory chronic Graft-versus-Host Disease (cGvHD) will continue to receive treatment at the same dose as per the original (parent) protocol.

• REC name

  Wales REC 1

• REC reference

  19/WA/0318

• Date of REC Opinion

  13 Dec 2019

• REC opinion

  Further Information Favourable Opinion