FLAIR Trial

This trial is comparing ibrutinib alongside rituximab with fludarabine, cyclophosphamide, rituximab and venetoclax for chronic lymphocytic leukaemia. This trial is for people who haven’t yet had treatment for their chronic lymphocytic leukaemia (CLL). The CLLSA supports this research.

 

The Flair Trial researchers think that ibrutinib with rituximab, or venetoclax, might work well for people with CLL who haven’t yet had treatment. To find this out they want to compare:

  • fludarabine, cyclophosphamide and rituximab (FCR)
  • ibrutinib and rituximab (This arm is of the trial is now closed)
  • ibrutinib and venetoclax
  • ibrutinib

The aims of this trial are to find out:

  • which treatment is the best for people with CLL that hasn't been treated  
  • how safe these treatments are
  • what are the side effects of these treatments

You may be able to join this trial if you have at least one of the following symptoms:

  • without meaning to, you have lost 10% or more of your body weight in the past 6 months
  • you are very tired and this affects your daily activities
  • you have had a fever for 2 weeks or more but have no sign of an infection
  • you have had night sweats for more than a month and have no sign of an infection

You must also:

You cannot join this trial if any of these apply:

  • you have already had treatment for your leukaemia
  • your leukaemia has transformed into Richter’s syndrome
  • you have leukaemia in your brain or spinal cord
  • you are to have major surgery within 4 weeks of taking part in this trial
  • you have an infection
  • at least 1 in 5 (20%) of your leukaemia cells have a faulty or missing p53 gene (your doctor can tell you this)
  • you have serious problems with your heart, breathing or digestive system (the trial team can advise you about this)
  • you have got HIV, hepatitis B or hepatitis C
  • you have had another cancer in the past 3 years apart from successfully treated non melanoma skin cancer and carcinoma in situ of the cervix
  • you have had a stroke in the past 6 months
  • you take other medication that affects body substances called CYP enzymes (your doctor can advise you about this)
  • you are taking medication to thin your blood, such as warfarin
  • you have any other medical condition or mental health problem that the trial team think could affect you taking part
  • you are pregnant or breastfeeding

We have supplied a map of trial centres and list of UK locations involved in the research. You must discuss participation with your CLL specialist as it may not be appropriate for your symptoms and medical situation.

If the link below does not work (Safari) then cut and paste the link into your browser to access the map.

https://www.google.com/maps/d/viewer?mid=16Jbl8Gd7yUX0mh3JdofRQptO6dY4Yw...

Todate, Sept 2018, they have recruited 950 patients out of the target of 1516 the trial is due to remain open to recruitment until 2020. The trial is recruiting to FCR, I and I+V treatment arms.

Thanks to Cancer Research UK for the image at the top of the article

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