Ibrutinib versus ofatumumab in relapsed/refractory CLL or SLL

• Research type

  Research Study

• Full title

  A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor Ibrutinib versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

• IRAS ID

  106023

• Contact name

  Peter Hillmen

• Sponsor organisation

  Pharmacyclics, Incorporated

• Eudract number

  2012-000694-23

• Research summary

  Chronic Lymphocytic Leukaemia (CLL)/ Small Lymphocytic Lymphoma (SLL), is a cancer of lymphocytes, a type of white blood cell. White blood cells are made inside our bones (bone marrow) and they travel in our blood and lymph glands to fight off infections. In CLL and SLL, the white blood cells are growing out of control and this can cause problems such as large lymph glands, large spleen, large liver, anaemia (low amount of red blood cells), and problems with blood clotting (low amount of platelets).The purpose of this study is to test whether or not the investigational (experimental) study drug (ibrutinib) works and is safe in patients with CLL / SLL compared to the comparator drug (ofatumumab). The study drug is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. The study drug is believed to block a kinase that helps blood cancer cells live and grow. By blocking this, it is possible that the study drug will kill cancer cells or stop them from growing. The investigational (experimental) study drug (ibrutinib) can be taken by mouth. The comparator drug is in a class of drugs called monoclonal antibodies. This type of drug works by killing cancer cells and has to be given directly into the vein (IV). This drug is approved by the EMA and certain other global health authorities for treating CLL that does not respond to other drugs. The purpose of this study is to find out: How well the study treatment controls cancer How cancer cells respond to the study treatment The side effects of the study treatment How long the study drug stays in the blood

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0502

• Date of REC Opinion

  8 Aug 2012

• REC opinion

  Further Information Favourable Opinion