Hello. I've just discovered this forum trying to find out some information about the drug Ibrutinib and it was great to read all the posts. I have been on W & W for about four years and I've just been told that chemo is now necessary.
I've been offered the chance (only 50% chance of course because it's random selection) to have Ibrutinib instead of Chemo. Is there anyone who has experience of being on a trial for this drug or can point me in the direction of any definitive results. If I elect to be put forward for the trial it will mean putting off my chemo for about three months and my reasoning is I could be halfway through chemo by then. Any help or advice would be gratefully received. Take care all of you. X
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Medwaylady
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Which clinical trial? Is there a crossover from the other arm to ibrutinib and visa versa, should you not do well in your selected arm, whichever it may be?
Also, your age is a consideration. I am on the RESONATE2 drug study/trial which is for patients aged 65 and over, not considered fit for FCR. The trial compares Ibrutinib with Chlorambucil. I was fortunate to draw the Ibrutinib arm but there is crossover for patients who don't fare well on Chlorambucil. Like you, I was nearly 4 years on W&W and at the point of treatment when I asked for a second opinion/referral to a CLL specialist. Now I'm at Bournemouth hospital, one of the centres for the study.
We need a bit more info from you. Are you under a CLL specialist? Which trial were you offered?
Hi fish, yes, I too have had great results but I am not too fatigued, it depends what I have been doing physically. I am in my second month and my neck and armpits are now clear of enlarged nodes, also my groin. I get out on the tennis court whenever the weather permits and cycle a lot. Next BMB and CT scan in month 5.
Thanks mikey, I am a tennis player also and I am not sure I have enough strength to hit the ball over the net with any pace...sure hope this fatigue goes away . where do you live ?? I am in Texas.....fish
I'm in the UK at Bournemouth. My consultant there, Helen McCarthy, is a former colleague of your Dr Bill Wierda. She worked at MD Anderson on CLL for a year.
Good Morning Cllcanada and Mikey47. Wow! How great to have such a quick response, definitely not expected. The treatment will be in London (I actually live in North Kent) and I have total faith in my Consultant who is a specialist in the field of CLL. I transferred from my local hospital after being asked to go on the CLEAR trial and I think this is what's bothering me because that trial was 'sold' to me as being a magic bullet cure and clearly hasn't been.
I'm 64 years old and very healthy, apart from the obvious, and considered to be an ideal candidate for selection. The trial is called FLAIR and is due to start in the New Year. My consultant said he was quite happy for me to go ahead immediately with FCR or I could wait until the New (I'm assuming it must be early in the New Year and I'm thinking Jan/Feb) and to be put forward for random selection for FLAIR. If I'm not selected for Ibrutinib I will be on the trial but with FCR.
I think what's bothering me is: How many other people have already trialed this drug with success. What are the side effects. Is it better than FCR or am I just a guinea pig. What happens when you stop taking the pill, I believe he said after six years. Should I just get on with Chemo, I was all psyched up for it anyway, and get it over and done with or will Ibrutinib have major benefits against Chemo in the long term. My consultant left the decision to me but his advice and he stressed advice only, would be to wait. But as he is running the trial I do wonder if he would only speak positively about it anyway. Hence my trying to find out more information independently.
I have searched on the internet but there is nothing there particularly constructive to answer any of the above. Unless of course I'm missing it.
Welcome to the community Medwaylady.(reposted this as earlier was full of typos)
I believe you may be referring to the FLAIR trial due to start early 2014 that is the new CLL10 trial Ibrutinib + Rituximab versus FCR for the treatment naive it has taken a lot to get off the ground was origionally planned for launch in November but has been delayed. It is perhaps the most revolutionary trial to date as it does deviate somewhat from the clinical standard of care.
Yes there is a 50;50 chance a participant would end on either arm. Coulkd it also be delayed further too? There is an optimum time for treatment and it may not be advantageous to pass that point in the hope of trialling an alternative to an effective agent. For after the wait as you identify you may just end up with what you can already have but be in less good shape to mount the best response.
This is a dilemma that has been discussed in the group several times. Here is a link when this was very recently discussed openly with by JBS60 healthunlocked.com/cllsuppo...
This trial was discussed by Dr Schuh at the recent CLLSA meeting and a few interesting pieces of information came from this:
•The trial will last for 6 years
•There will be crossover if there is evidence of disease progression
There is much evidence about Ibrutinib in trial now but that over the longest duration is in small cohort trials that have not spanned over many years, There is no evidence within the same controlled population of how in combination with Rituximab it compares directly to FCR .This is why this trial is so important i believe. I have listened to several of the arguments pro and con and can see both sides of the coin.
FCR a chemoimunotherapy is a one off proven treatment course, it is the standard of care and may provide a lasting remission. There is a lot of evidence supporting this ..
The Novel targeted therapy combination of Ibrutinib + Rituximab may achieve a good remission that has to be kept stable by continued use of the drug for the time of the trial period. Effects and remission duration over a long period of time are not yet fully understood.
The message I am also reading is that the BCR inhibitor trials may buy you more time for later treatments as new drug come available in trial or gain approval.It is a dilemma..
there are many here in the group who will share their experience.
Re the Flair trial, can you tell me what the revolutionary deviation from the clinical standard of care actually means? Also, do you know if there is a standard treatment and assessment list for FCR so that it is then possible to determine what normally happens during the treatment period?
I think a clinician giving us a talk on this also called it quite a "brave" trial. I suspect for many reasons. It has been a long time in set up, hopefully soon the full supporting information will become available, May is now the last quoted commencement date.
I understand FCR is the proven standard of care for the fittest group of patients requiring first line treatment. "FCR is recommended as initial therapy for previously untreated fit patients outside clinical trials"onlinelibrary.wiley.com/doi...
In the FLAIR trial FCR is going head to head with a novel non chemo BTK inhibitor in combination with a non chemo monoclonal antibody.
The trial is randomized, a significant group will be randomly selected for the non chemo combination arm as a first-line approach to treating their disease as an alternative to FCR. This deviates immeasurably from the standard of care for this population. Could this trial provide trial data that could change how CLL is treated or not in the future? .
Or is it a starting point that may pave the way for other non chemo options to be trialled in different designs and combinations in this group?
An interesting choice for candidates; a gamble to gain access to a non chemo treatment and a brave trial of the new drug Ibrutinib in combination against FCR which could not be considered a "straw man" comparator ? Revolutionary? perhaps
Assessment list from Guidelines on the diagnosis, investigation and management of chronic lymphocytic leukaemia Assessing fitness for treatment
"Patients requiring treatment should be assessed for their ability to tolerate myelosuppressive and immunosuppressive therapies. Important factors include age, performance status, significant co-morbid conditions, especially a creatinine clearance of <60 ml/min and susceptibility to infection. The use of scoring systems, such as the Cumulative Illness Rating Scale (CIRS) score may be helpful, but none of the currently used scores is CLL-specific and careful assessment of individual patients remains paramount (Miller et al, 1992; Extermann et al, 1998). Although the outcome of patients over the age of 65–70 years entered into clinical trials of FC and FCR was comparable to that of younger patients (Catovsky et al, 2007; Hallek et al, 2010), this data should not be extrapolated to elderly patients with co-morbidities, as these patients have a higher incidence of myelosuppression, often fail to tolerate a full course of treatment and generally have a poorer outcome with therapy (Tam et al, 2008)."onlinelibrary.wiley.com/doi...
I copied the following from another group, and since you are asking about a subject that has been vigorously discusses on all these CLL groups, I encourage you to search the archives of them, so you can see all the answers previously written: BTW Ibrutinib and Idelalisib (aka GS-1101) are referred to as Kinase inhibitors below.
To paraphrase (hoping I don't misrepresent anyone's ideas), Dr.
Furman envisions a future in which kinase inhibitors and other
new drugs which are gentler and less damaging than chemotherapy
will keep the disease at bay indefinitely. Patients will change
drugs if and when the agents they use become ineffective.
Avoiding chemo is important because patients who take it can
develop bone marrow failure and other very dangerous conditions.
Dr. Wierda is hopeful and excited about the new drugs, but he
thinks FCR is appropriate for some patients because it gives a
chance at a cure. I think this statement is based on recent MD
Anderson (MDA) data about some patients with very long complete
remissions, and the MDA people have begun using the C word (cure,
not cancer). If it is a cure, this cure is only possible in
patients with the most favorable markers and indolent disease.
This group constitutes a small percentage of CLL patients.
Opinion: I think there's some institutional bias at work here.
FCR was put into early clinical practice at MD Anderson, and docs
from there promoted it very heavily during the past decade. The
organization is heavily vested in this treatment protocol.
Both videos, featuring two of our best CLL docs, make compelling
Thank you Lenkeck for this post. It never ceases to amaze me how people are so willing to take the time and trouble to answer these questions. I am going to study the links when I have peace and quiet to concentrate.
Apologies for cross-posting on two threads for fear of looking like a limelight hogger (although this would not be my preferred stage...) but I have responded (at length as usual) to Medwaylady on this subject in detail on my original thread about this dilemma (linked to by Nick in his Hairbear post above) and thought it might be useful to add the bulk of it to this thread for anyone new floundering about out there in the networks and hoping to find some dialogue and resources to help them:
Hi L - thank you for this.
It is a problem, and one that is dominating my world right now!
have done some research on this too, and it does now look as if the earliest recruitment date will be the end of January, possibly February or March if the paperwork doesn't go through on time in December.
I seem to be in a very similar position to you, although my consultant seems less confident that I can hold out until next year in the face of my very evident disease progression, especially if there are further delays with the trial start date. They are prepared to let me wait with very close monitoring if I insist, on the proviso that if things continue as they are I am very unlikely to make it to the trial without treatment becoming an absolute necessity.
Like you then, I face the dilemma of FCR now or hang on, possibly reducing my 'performance status' (general fitness for treatment) for a 50% chance of ibrutinib whenever it happens next year. I also have the additional issue of prolonged absence from work, as I'm signed off now due to fatigue, enlarged spleen, infections etc., and can hardly afford to prolong that by an extra three months at least as it will take me beyond my six months full paid leave. I think I would definitely overlook all of this if I new I would get ibrutinib for sure, but the thought of all this waiting, worry, surveillance and symptom control seems like very high stakes with a 50% chance of ending up with FCR anyway further down the line when I'm less fit for a good response...
And then I think, but FCR is good and, despite its attendant risks, produces excellent remissions in the right patients. I'm 13q- and mutated (I think, based on my CD38 expression), young, fit (on the surface anyway), and so should be able to expect a good result as far as anyone can ever predict anything with this disease. My consultant is pretty sure that by the time I relapse, the small molecules will be available for second line treatment, and thinks that this is my best strategy - particularly as their long-term efficacy and safety for first line treatment has yet to be demonstrated. We are consulting with a CLL expert about my particular case, but as it stands I'm booked in for FCR next week, so unless we get a radically different perspective in the meantime, I guess that's what I'll be doing.
Professor Peter Hillmen is interesting on this - you've probably seen it, but here's a link to a video he made on this very subject. Of course, he is to some extent bound to say this given the current lack of access to first line small molecule drugs in this country, and the need to keep people alive (and as a bonus - willing to chuck their hats in the ring to trial FCR against ibrutinib) in the meantime. There is also a lack of overt acknowledgement of some of its particular dangers, but it's hard to argue with the positive evidence for this regimen for some patients:
Also - Chaya Venkat's amazing meta-analysis of FCR research is very useful, and might help you get the pros and cons of FCR a bit clearer in your head.
CLL Updates - Everything you wanted to know about FCR (August 2010 Workshop)
Dr Wierda is my MD and after 2+ years (It was probably 6+ years) of watchful waiting he put me on the resonance 2 study and I was lucky enough to get Ibrutinib........However I was also told that if I get Chlorambucil and did poorly or could not tolerate it, I would be switched to Ibrutinib.. There was no decision to make.. I was fully ready to accept the Chlorambucil and if it did me no good ... I would get Ibrutinib,,,, check with your Md. and see if this is true ... If you get a negative answer call MD Anderson and talk to Dr Wierda or James Gi (man in charge of the study)l.... I was with both for a few hours yesterday and I know I heard the above comments.
You might go to "clinical trials .gov" and see the requirements for the study....... I get a boatload of info from many people and web sights and Somewhere I read that Ibrutininb and Rituxamin (an intravenous chemo with many side effects) seems to have a near 100% in putting you in remission..
One other bit of info the Company expects that the cost of Ibrutinib will be around $125,000 per year per patient..
Time to go to the VA where drugs are free( I have heard)
After 30 days on the Ibrutinib I am almost completely free of tumors that were 2 to 3 cm and the ones left are 1/2 cm or less...... The only problem I have is fatigue and that should go away in months.... my WBC went from over 20,000 to 7,000 in 30 days... call MD Anderson and ask for James gil or Dr. Wierda..... luck and thoughts...Fish61
You didn't mention WHY your Doctor said you needed treatment now. I will assume that's true, and since you posted 5 months ago, you may well be into your trial and have some results from treatment. But if the other arm of your trial is chemo, and it's a blind trial, then it seems that some form of chemo is used in both arms of the trial and a placebo is given in the non-Ibrutinib arm of the trial.
So my question is, in the U.K. (I'm in the U.S.), do you have a trial option that DOESN'T include chemo (fludarabine, cyclophosphamide, chorambucil, etc.)? Ibrutinib has been approved for previously treated CLL in the U.S., but I think there are trials that include a newer drug like Ibrutinib without a chemo arm.
A trial with Revlimid (lenalidomide) might be another option. It may have a few more side effects that Ibrutinib, probably depending on the individual. I am on a Revlimid/Rituxan trial, which I sought out after relapsing. It is working well.
So if you know your genetics and can mention your symptoms, that might be helpful.
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