VENICE-I: a phase 3 trial testing venetoclax for people with relapsed or refractory chronic lymphocytic leukaemia

This trial is testing the targeted drug venetoclax for people with chronic lymphocytic leukaemia (CLL) that is difficult to treat.


Purpose of trial

The aim of this trial is to test how well venetoclax works for people with CLL that has come back (relapsed) or didn’t respond to previous treatment.

The trial is testing whether venetoclax works for:

  • people with certain genetic changes in the lymphoma cells (17 p deletion or p53 mutation) - your doctor can advise if this applies to you
  • people without these genetic changes who have previously been treated with ibrutinib or idelalisib.

Treatments

Venetoclax is a newer drug that is being tested for people with CLL. It targets and blocks a protein important for survival of some lymphoma cells, called Bcl-2.

Everyone in this trial has the same treatment.

You take venetoclax tablets orally (by mouth) once a day. You start at a low dose and the dose is gradually increased over the first 5 weeks of treatment. This helps to prevent serious side effects. You can take venetoclax for up to 2 years as long as it is controlling your CLL and is not causing troublesome side effects.

After your treatment, you have regular check-ups (follow-up). You are followed-up as part of the trial for up to 2 years after treatment to track your progress.


Who can enter

Your consultant can give you advice on whether this trial might be suitable for you.

A total of 250 people are needed for this trial.

You may be able to enter if:

  • You have CLL that needs treatment.
  • You have had at least 1 previous course of treatment and have 17p deletion or p53 mutation OR you have had at least 1 previous course of treatment with ibrutinib or idelalisib.
  • Your CLL is measurable with the tests used in the trial.
  • You are well enough to look after yourself and are up and about more than 50% of your waking hours, even if you are not well enough to work.
  • You and your partner are willing to use reliable contraception during treatment and for at least 30 days after treatment if there is any chance of you or your partner becoming pregnant.
  • Your blood and other health test results are satisfactory.
  • You are over 18.

You will not be able to enter if:

  • You have Richter’s transformation (your CLL has changed into a more aggressive form) or prolymphocytic leukaemia. You have had venetoclax before.
  • You have another cancer in the last 2 years, except certain localised cancers that have been successfully treated (the trial team can give you details if you might be eligible).
  • You have autoimmune haemolytic anaemia or autoimmune thrombocytopenia that is not well controlled.
  • You have had an allogeneic stem cell transplant.
  • You have had treatment for CLL within the last 14 days or longer if it might still be in your system.
  • You have had a biological anti-cancer drug, for example an antibody, in the last 30 days.
  • You have had a bad reaction to both xanthine oxidase inhibitors and rasburicase (drugs that reduce uric acid) in the past.
  • You have any serious health problems that might make it unsafe for you to have the trial treatment.
  • You have HIV.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at clinicaltrials.gov