Chief investigator - Professor Peter Hillmen, St James's University Hospital
A phase II assessment of the mechanism of action of venetoclax (ABT-199) in combination with ibrutinib (PCI-32765) in relapsed/refractory chronic lymphocytic leukaemia
Award start date: 01 Jan 2016
Recruitment start date: 20 May 2016
Award duration: 5 years

This study is for people with chronic lymphocytic leukaemia (CLL) that has come back or treatment has stopped working.

We know from research that ibrutinib 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. In this trial, researchers want to find out how well ibrutinib works alongside another drug called venetoclax. Venetoclax is a type of drug called a Bcl-2 inhibitor. Bcl-2 is a protein that controls a pathway in cells that causes cells to die, and high levels of this protein helps cancer cells survive indefinitely. Venetoclax works by blocking the effects of Bcl-2 causing cancer cells to die.

The aims of the trial are to:

  • Find out how well ibrutinib and venetoclax work together
  • Find out how safe the combination treatment is
  • Learn more about the side effects

You may be eligible to join this trial if:

  • Your CLL didn’t go away completely or only went away a little bit (you didn’t have a complete or partial response), or your CLL came back within 6 months after having a drug such as fludarabine alone or with chemotherapy
  • You are at least 18 years old

Other eligibility criteria apply.