RAY- PCI32765MCL3001

• Research type

  Research Study

• Full title

  A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton’s Tyrosine Kinase (Btk) Inhibitor, Ibrutinib, versus Temsirolimus in Subjects with Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

• IRAS ID

  112190

• Contact name

  Simon Rule

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2012-000601-74

• ISRCTN Number

  n/a

• Research summary

  Ibrutinib (JNJ 4179060: PCI-32765) is a first-in-class selective, irreversible small molecule inhibitor of Bruton??s Tyrosine Kinase (BTK) currently being co-developed by Janssen Research & Development, LLC (JRD) and Pharmacyclics, Inc. It has demonstrated single-agent activity in several B-cell lymphomas, including relapsed mantle cell lymphoma (MCL), with an acceptable safety profile.Despite recent advances in the treatment of MCL, it remains a serious and fatal malignancy for which there is an unmet medical need, particularly for those patients who relapse or become refractory to treatment. Once the disease has progressed upon initial treatment, the prognosis is dismal, and following relapse, the median survival is around 2 years. Like all lymphomas, the expected survival is progressively shorter with each subsequent relapse. Therefore, more effective treatment for patients with MCL who progress after initial therapy is needed. As an oral daily treatment, ibrutinib may offer a treatment option to this patient population with rare and lethal disease.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0401

• Date of REC Opinion

  11 Oct 2012

• REC opinion

  Further Information Favourable Opinion