CAN3001 version 1.0

• Research type

  Research Study

• Full title

  A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

• IRAS ID

  118772

• Contact name

  Simon Rule

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2012-004225-24

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Ibrutinib (PCI-32765) is being investigated for the treatment of subjects with various blood cancers (e.g. chronic lymphocytic leukaemia/small lymphocytic lymphoma, mantle cell lymphoma) Subjects are currently being enrolled into protocols which look at how effective Ibrutinib is for these separate illnesses. This study is to allow subjects who are benefitting from Ibrutinib to continue to receive the drug after these studies finish and to collect information about the long-term effectiveness and safety of the drug. To enter the study subjects must: ?½ have completed the parent protocol ?½ have received at least 6 months of treatment with Ibrutinib ?½ are actively receiving treatment with Ibrutinib, ?½ their doctor thinks that the benefit of continued Ibrutinib therapy will outweigh the risks It is anticipated that approximately 200 subjects world-wide will take part, with up to 25 in the UK. The study will be conducted at NHS Hospitals already taking part in Ibrutinib studies. Subjects can receive a maximum of 3 years treatment on this study and will continue with the same dose of drug they received in the parent protocol until their doctor decides: ?½ that the subject is no longer benefitting from treatment ?½ study is terminated by the sponsor ?½ the subject withdraws consent, ?½ alternative access to Ibrutinib is available and feasible according to local policy, ?½ subject should terminate for other reasons as defined in the protocol.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  13/EM/0015

• Date of REC Opinion

  15 Jan 2013

• REC opinion

  Favourable Opinion