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CLL Support Association
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FLAIR trial - restrictions

My dad has CLL and requires treatment. He has been offered the opportunity to join the FLAIR trail but yesterday's appointment hit a sticking point, he also has prostate cancer. The consultant and research nurse were not sure if this would impact his eligibility for the trial. Waiting for an answer....

Does anybody know about FLAIR restrictions & if his prostate cancer will be an issue?

Many thanks

Claire

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Hi can’t answer you question just wanted to say good luck to your dad.

Ann

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Thank you Ann

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Hello Claire, thank you for posting your question which must be causing you some distress while waiting for a definitive answer from the trial team. I can see why the trial team see it may be an issue,

The broad exclusion criteria for the trial are listed on the Cancer Research UK website here: cancerresearchuk.org/about-...

They are as follows:

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 Open a glossary item (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

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The CLL UK/NCRI CLL clinical trials group are meeting tomorrow, exclusion criteria clarification will be sought by patient group representatives.

Nick

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Thank you so much for your response. It is a little frustrating not knowing what is going to happen next. It is strange that my dad has been considered for the trial when he has another cancer & that it is on the exclusion list! Hopefully they will provide a definitive answer soon.

Many thanks

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I will be starting the Flair trial on Wednesday (UK) and the computer has chosen Ibrutinib as my treatment.

I have pre existing AF and take Diltiazem, Flecainide and the anti-coagulant Dabigatran (Pradaxa) to control it. My haematologist is well aware of my condition and medication and has said ther is no problem; they may just have to alter the meds to suit.

Netty

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Thank you for your reply, good to hear you have still been accepted on to the trial. Hope all goes well for you.

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Thank you CMSherman

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