Anyone know if CLL 10 trial (FCR v Ibrutinib+R) is open for recruitment anywhere in UK?

Saw my consultant today and, unsurprisingly (given my recently enlarged spleen and neck nodes, and a downturn in my HB and platelets), he is suggesting that it is chemo time for me. He wants to start me in early November, after my current chest infection has settled, and he's had time to run cytogenetics etc.

Obviously, I'm doing my homework in the interim. We talked about the CLL10 trial, but he thought that it may now be full...he's checking that for me, but I thought I'd ask here amongst the biggest group of experts I know!

If anyone knows, or can point me in the direction of a Doc at any of the centres running the trial, I can help my consultant on my own behalf. It is very difficult to find information about the trial's progress anywhere online.

Mikey - I know you are on the trial, and you said recently that you thought it would be full by Christmas - can you tell me where you got that information please...I think I need to move very quickly, if it's not too late already to get a shot at the ibrutinib arm ...I've edited this post though because I think you are on Resonate? If so - that's not appropriate for me...but maybe you have some info anyway, being at Bournemouth :-)

Hope everyone is doing okay. x

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10 Replies

  • Jibs,

    Obviously I don't know your complete Dx - but I am on the B + R and Idelalisib / placebo clinical trial in Birmingham. - see other posts I have made !

    I understand both Idelalisib & Ibrutinib are similar P13K inhibitors - so you might like to look at this option!

    Quote ->>> In a US Oncology Report dated 11/6/13 "Idelalisib produce responses in 97% with CLL" - the conclusion "I've never seen anything like this in CLL before" - the shrinkage of nodes was noticeable after a WEEK and there was a frightening increase in circulating lymphocytes --- "which reduce gradually."

    In general terms - my body's response is similar to the above !

    Do not hesitate to ask me anything further - Marty - young 60 !

  • Ibrutinib is a Bruton's tyrosine kinase (BTK) inhibitor...

    Idelalisib is a phosphatidylinositol 3-kinase (PI3K) - delta inhibitor

    Different targets...

    No trial listing here yet...

    From Macmillan...

    'CLL 10

    Phase III randomised trial for previously untreated patients considered fit to have FCR. The trial is to assess whether Ibrutinib (PCI-32765) in combination with Rituximab (Ibrutinib+R) is superior to the current standard treatment of Fludarabine, Cyclophosphamide and Rituximab (FCR).

    The trial is planned to open in November 2013 replacing ADMIRE and ARCTIC.'

  • Thank you for this Chris,

    I couldn't find the CLL10 trial anywhere either, which confused me as I was basing my assumptions on the same info from Macmillan and CLLSA UK about it starting in November, and replacing ADMIRE and ARCTIC.

    I confused it with the Resonate2 trial at first, but realise now that that is a different trial for patients over 65/not considered fit for FCR.

    So the question is ... where is CLL10?

    Anyone know...?

    All the best.


  • Hi Jules

    As time may be pressing for you

    You could ask your doc to seek clarification from Professor Peter Hillmen he heads up the CLL trials group of the NCRN. he's an approachable guy,.Prof Andy Pettitt also sopke on the clinical trial picture at the CLL Forum sciences day last week but his talk was shortened a tad due to a late running schedule. he confirmed it was coming and in set up, again no start date was given he may also be usefull to your doc for information..

    Of course you know this is also a randomised study so it's a roll of the dice which arm you may end up on. but yes from what I am learning this may be the only way someone fit for FCR could gain access to Ibrutinib on a trial here in the UK for the moment..

    There is no information out there over what Chris has posted above, they are holding their cards close to their chest

  • Ah, cheers Nick - I wondered if you might have any useful contacts.

    I'll get on to that right away ... don't want to start FCR if this one is really imminent and I could at least get a crack at ibrutinib...but obviously need to chuck something at this disease asap, so it's all about the timing now...

    How're things going with you my friend? Very aware you have a lot on your plate right now too...


  • thanks for asking jules

    All being well medical issues should be back in hand soon.

    No solids after 12 midnight tonight as am on the cardiac table tomorrow for angioplasty and no more I hope. all being well will be up and about same day. fingers crossed.

    I've been having to get about a bit and quite busy recently fueled by progress in CLL initiatives this I find uplifting if hard to keep up with. Will have to chill out for a few days enforced laziness and hope to be good again for Oxford next week.

    maybe a tad nervous about tomorrow

    nick xxx

  • Good luck and thinking about you for tomorrow Nick x

    Hope you manage to get on a suitable trial Jules, sorry it's come to 'that time!'...

    Warmest best wishes,

    Newdawn x

  • Thank you Newdawn,

    To be honest, I'm beginning to feel so compromised that I view treatment now as a necessity rather than the thing I've wanted to avoid since I got diagnosed...looks like CLL10 due to recruit in Jan 2014 or thereabouts, but no definite date as yet, so I may not be able to hang on as my disease seems to have really taken off over the past few months since I last saw my consultant. May just be FCR for me then (which of course it may have been anyway on the randomized trial), but we'll see...I'll keep you posted as this new stage unfolds...

    Hope you are well?

    Jules x

  • Sorry you're beginning to feel that you're trying to push the tide back now Jules...hoping you can hold off for an alternative but FCR can be spectacularly successful if it becomes necessary. Just seems tantalisingly close to less toxic alternatives so I understand your position. Sorry that you've reached that point but I realised from your posts that things were galloping a bit lately.

    I'm ok thanks, got a cold at the moment and just hoping it doesn't linger or develop.

    Good luck with things Jules, wishing you well,

    Newdawn x

  • Hi Jules,

    I don't suppose you were envisioning such a personalised study plan when you commenced your PhD...

    Sorry you've got to this point, but your youth and acceptance should give you an advantage in whatever treatment option becomes available when you need it.

    All the best,


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