IciCLLe extension

Chief investigator - Professor Peter Hillmen, St James's University Hospital
A phase II assessment of the mechanism of action of PCI-32765 in B-cell receptor pathway inhibition in CLL
Amount awarded: 5 years (60 months) – funding includes the IciCLLe study)
Award start date: 01 May 2014
Recruitment start date: 04 Dec 2015
Award duration: 5 years (funding includes the IciCLLe study)

At the moment bone marrow transplantation is the only cure for CLL, but some people may not be able to undergo this treatment because they are too frail. Chemotherapy can be effective, but can have serious side effects especially in older people.

We know from research that ibrutinib (also known as PCI-32765) can help people with CLL. Ibrutinib is a type of biological therapy called a Bruton’s Tyrosine Kinase (BTK) inhibitor that stops signals that cancer cells use to divide and grow. But we still need to know more about how it works, so doctors can understand how to combine ibrutinib with other drugs to make more effective treatments. One drug that could be combined with ibrutinib is obinutuzumab. Obinutuzumab is a monoclonal antibody and works in a similar way to rituximab, in that they both target a protein called CD20 on leukaemia cells. When obinutuzumab binds to cells that have CD20 on their surface, it triggers the immune system to attack the marked cells and kill them.

People who are already taking ibrutinib as part of the IciCLLe trial were asked if they wanted to join the IciCLLe extension trial. This trial is also open to people who have CLL that has continued to get worse during treatment, or have relapsed after treatment.

Everyone who takes part will have ibrutinib and obinutuzumab.

The aims of this study are to:

  • Find out how well ibrutinib and obinutuzumab works for people with CLL
  • See what the side effects are

You may be eligible to join this trial if:

  • You have CLL that needs treatment
  • You have CLL that has relapsed, or continued to get worse during treatment
  • You are at least 18 years old