HELIOS - PCI-32765CLL3001

• Research type

  Research Study

• Full title

  Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination with Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

• IRAS ID

  110332

• Contact name

  Paul Moss

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2012-000600-15

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Ibrutrib ( also referred to as PCI-32765 or JNJ 54179060) is a first-in-class selctive , irreversible molecule inhibitor of Bruton's tyrosine kinase (BTK) currently being co developed by Pharmacyclics Inc and Janssen Research &Development, LCC (JRD) for the treatment of B-cell malignancies. Although there have been impressive gains in treatment and understanding of the biology of Chronic lymphocytic leukemia (CLL), the disease is incurable using chemotherapy. Stem cell transplan may be curative, but few patients undergo this treatment. In general, the more relapses that patients suffer, the more resistant the disease becomes to therapy.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  12/EM/0291

• Date of REC Opinion

  27 Sep 2012

• REC opinion

  Further Information Favourable Opinion