DAWN PCI-32765FLR2002

• Research type

  Research Study

• Full title

  An Open-label, Multicenter, Single-arm, Phase 2 Study of PCI-32765 (ibrutinib) in Subjects with Refractory Follicular Lymphoma

• IRAS ID

  121144

• Contact name

  Robert Marcus

• Sponsor organisation

  Jansen-Cilag International NV

• Eudract number

  2012-004097-26

• Research summary

  Treatment options for patients with follicular lymphoma who are resistant to chemoimmunotherapy, such as rituximab are very limited. Early indication from the open-label Phase 1 study suggests activity of PCI-32765 in follicular lymphoma (FL) and have provided an encouraging response rate. The primary objective of this study is to evaluate the efficacy of PCI-32765 by exposing a greater number of patients to the drug. Safety and duration of the response to Ibrutinib are important secondary objectives.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  13/LO/0039

• Date of REC Opinion

  19 Feb 2013

• REC opinion

  Further Information Favourable Opinion