BELIEF

• Research type

  Research Study

• Full title

  A Multicenter, Open-Label Trial of Belinostat in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma.

• IRAS ID

  48617

• Contact name

  Claire Dearden

• Sponsor organisation

  TopoTarget A/S

• Eudract number

  2008-005843-40

• ISRCTN Number

  not known

• Research summary

  This is an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma who have failed at least one prior systemic therapy. Approximately 120 patients will be enrolled over a planned recruitment period of 24 months. Patients will be treated with 1000 mg/m2 belinostat administered as a 30 minute IV infusion on days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/74

• Date of REC Opinion

  10 Aug 2010

• REC opinion

  Further Information Favourable Opinion