CLL Support Association
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Do I go on a trial or not

Hi all I have only posted a few times but I do follow the posts everyday,most helpfull.my question is as the title says,I very confused aso which way to go now.the specialists have told me it is time to start treatment and gave me a lot of info to read?they can offer me the first or they have said there is a trial which consists of 1.fcr 2.ibrutinib 3.ibrutinib+venentoclax

Apparently a computer decides.how do you decide which way to go,I'm a bit confused.any advice would be most appreciated

Many thanks in advance dan

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I expect you'll find this post by AdrianUK of interest, given he has just gone through the same decision making process you are looking at doing: healthunlocked.com/cllsuppo...

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Hi Dan

I’m currently on that trial and started 2 years ago! although the arm I was given has now closed as full..

You don’t receive any additional care than you would just taking FCR thru your specialist for the exception of deeper blood monitoring,but you do have the option of receiving one of the newer targeted therapies like the one I’m currently taking or have the chance at receiving the possible golden ticket if You get offered the I/V arm.

Personally given the choice again I’d opt for the trial as your given the chance to further help research the newer therapies coming to market and it gives you an opportunity to avoid the old fashion chemo route which I think would only be viable given you have the correct markers.

Ibrutinib has worked very well for me and still does now.

Stuart

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Hi Dan. Know you aren’t alone. Lots of us on here are either in the flair trial or thinking about it (I’m waiting to hear what I will get). If you’ve got any questions after looking at some of my posts and others who’ve posted about their own experiences only too happy. It’s a difficult time deciding whether it’s time for treatment and what to do. We all understand that.

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Hi Dan, I will be facing the same decision soon and have decided to opt for the FLAIR trial as I figure that this is my best option rather than choosing FCR straight away.

I know that there's a 1/3 chance of getting it anyway however based on the positive experiences of others in this community am prepared to take a chance.

Good luck with whatever you decide. Thinking of you.☺

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Go for it Elizabeth. Wish you well whatever decision you (and maybe the computer) makes. Looks like we may possibly be FLAIR buddies. There’s more and more of us on here!

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Next appointment is on 5th October so keep you posted.

I hope that the computer selects the best option for you Adrian 🙏

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Thanks Elizabeth. As I was explaining to Dan I genuinely don’t know what’s the best and can see pros and cons for each. So I’ll take whatever I’m given!

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Hi everyone, seems there are a lot of us facing this decision, fortunately mine has been delayed as my scan and blood tests came back better than expected and they decided not to start treatment until absolutely needed.

I posted the same question a few days ago and these guys were so much help, especially Adrian and his previous postings.

Good luck with whatever you end up on.

Anne x

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All the best Anne. Well done for dodging the bullet this time. I still have a fantasy of my blood test in two weeks being way down and them saying it’s all a mistake....doubt it tho!

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Thankyou for your answers they have been very helpfull. It looks like you have tried to enrol in the trial,that's the way I am now thinking,reading the paperwork that they have given me with regards to possible side effects is quite off putting though.I am unmutated they have told me.It does sound a bit of a lottery,having to rely on a computer to decide what you are having though.they have also said I have a 13q deletion.I will keep on reading to try and decide,I'm am used to hospitals telling me what to do with regards to healthcare, this why it is a bit scary having to decide for yourself

Many thanks dan..

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Hi Dan. You have the exact same markers as me. The issue is that all there arms of the trial will almost certainly work. The only question is for how long and how deep your remission will go. I know what you mean about it seeming scary. None of the arms are totally experimental. They all have a license for treating CLL (just one of them only for third line and one of them is not funded by the NHS first line). They will look after you well and explain it all. Have a look at my posts and others and hopeful it will make it all clearer. The side effects are a bit scarey. And that’s why they don’t like to treat us too early. But if your illness is developing rapidly then the idea is the benefits will outway the risks. Remember not everyone gets all those side effects. Ask to speak to the research nurse more (they can ring you between appointments). And have a look at all the many posts on here by people who’ve been on FLaIR already or who have taken FCR or Ibrutinib outside of a trial.

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Dan, its really an individual decision you have to make based on what's right for you. There are advantages and disadvantages to a trial.

The issue I had to decide recently when starting treatment was whether to do chemo (fcr) or ibrutinib or ibrutinib/venetoclax, the same combos in your trial. Since I have mutated igvh, fcr arguably offered me a chance at a cure, but at the risk of doing marrow damage and an increased chance of secondary cancers.

Ibrutinib offered me the chance of long term disease control without the harsh effects of chemo. Whenever I became resistant to ibrutinib, if I ever did, I would be in better shape than if I had done chemo, in theory.

Ibrutinib/ventoclax gave me a chance for a deep remission, but I saw venetoclax as my fallback drug if ibrutinib failed. Should I shoot both my guns in my first treatment?

After much deliberation and the advice of my doctor, I chose the I/V trial, but promptly flunked out with a bout of AIHA.

Now I am on single agent ibrutinib and it works great for me. Since I am not in a trial, my doctor has much more flexibility to add and subtract drugs to my treatment, including venetoclax. I will not have to do all the scans, labs and bone marrow biopsies I would have had to do in the trial.

What would concern me about your trial is that you are letting a flip of the coin decide for you what treatment you will do. That said, if you have mutated igvh, all of these three choices are reasonable. The main controversy would be over chemo vs non chemo. A certain subset of fcr treaters are at 20 year remission now, which is awesome. The counter argument is I/V combo users may get remission like that without dna and marrow damage chemo can cause.

For me, I think I might be better off outside the trial. My doctor can duplicate the I/V trial I was going to be in for me, but with more flexibility and without me having to do all the scans and BMBs. But I think I would have done well in the trial too, and depending on your insurance, financial situation, and what the trial covers, there could be financial advantages to a trial as well.

I hope I haven't confused your decision. If I were you I would ask my doctor what treatment he thinks is optimal for me and why I would let a flip of the coin decide that. The answer might me he really doesn't know and that all three trial arms present equally reasonable choices for you.

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It’s important to stress the differences in practice. In the UK unless Dan has very deep pockets or private insurance he will be offered FCR only on the NHS. So given the pros and cons (which I also write about) and the fact that even the experts don’t know what is really for the best, allowing a computer to decide has been strangely comforting! And I don’t even know what I’ve got yet!

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You are free to leave the trial at any point at your discretion! However there are additional tests such as a few bone marrow biopsies and an occasional CT scan! But In my opinion the possible long term risks FCR holds far outweigh a few additional checks.

Also many of the latest targeted therapies are in the later stages and deemed just as safe.

Stuart

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Wow! Your reply was very helpful to me as well, because I wished to have been on the Ibru-Ven trial but your input, for the first time, made me realize i might actually be better off to just be on Ibrutinib because I do not need to do all the extra testing and protocol associated with a trial and yet my Doctor can add Venetoclax or something else later, if (or most likely ...when) need be.

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Yes I really cannot comment on the insurance and UK issues, just about what treatments are best.

In re-reading your post, Dan, I see you are unmutated igvh. I personally would not take the risk of being assigned to an fcr arm in this trial if I were unmutated. On average people with unmutated cll get shorter remissions with fcr, so I would not risk the damage chemo does for a remission that might not be very long.

I think the consensus among most cll experts, perhaps not all, would be that a first time treater with unmutated cll would do much better with ibrutinib than fcr.

I considered fcr because I am mutated and the possibility of a long, if not permanent, remission after only six months of treatment appealed to me. I ended up choosing ibrutinib and am happy with that choice. Based on what we know now, its a drug that does the least harm to me so I will be on better shape for my next treatment, whatever it might be.

I might see if I were you if I could find a trial with ibrutinib and or venetoclax without a chemo option. Even in this trial, there is a two of three chance you cont get chemo I suppose.

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That isn't the view of UK experts. The fact is that people with unmutated genes DO respond to FCR. They just don't respond for as long as mutated. There is no clear evidence that giving someone ibrutinib at that point would be less effective than giving it first line. And we do not have evidence for the LONG remissions that we see on FCR in some patients for ibrutnib yet because its not been here long enough. So, whilst most UK experts would agree that eventually perhaps FCR will be superseded they DONT believe that we are at that point yet. In the UK everyone who doesn't have 17p deletion/TP53 will have two options for their firstline treatment: take FCR on the NHS or enter the FLAIR trial and have an option of not having it. So, the ONLY way to have a chance not to get FCR is to enter FLAIR unless you have very good private insurance (and can guarantee that insurance company will keep paying for it for up to ten years or more) or if you have VERY deep pockets yourself. So for the UK person who is unmutated the FLAIR trial is actually more attractive even than for a mutated person. We don't actually know whether FCR first is better or worse in the Long term than ibrutnib first when you can definitely get ibrutinib second. We no longer have the threat of being forced to do FCR twice in the UK, so even if FCR only bought us say 4 years, what if that is an extra 4 years of LIFE before Ibrutinib stops working? Perhaps ibrutinib will give us 10 years. FCR first then Ibrutnib might give us 14! Of course we are all flying blind because the LONG TERM data isn't even available for FCR yet (I want to live a LOT more than 12 years!). So for me given the uncertainly it makes sense personally to volunteer for FLAIR which I have done with exactly the same markers as Dan (13q del and unmutated IGVH).

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Hi bassejm,

As Adrian has explained in his more comprehensive post below, we don’t always have this luxury of choice in the U.K. as NICE have yet to approve the use of Ibrutinib for first line therapy for CLL’ers who are do not have 17p/TP53 deletions. Flair therefore represents the opportunity to acccess non chemo alternatives otherwise denied us presently.

I’m afraid the issue of mutational status isn’t given the same prominence which many of us believe it should in clinical treatment decisions in the U.K.

It’s therefore important to be sensitive to the fact that differing health systems offer different opportunities and for many of us in the U.K., the Flair trial is about as good as it gets at the moment.

Regards,

Newdawn

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I like that. It almost sounds like a sound bite for an advert “Flair: as good as it gets (in the UK)”

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Rew

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I will try to clarify my posts. I never wrote that unmutated people do not respond to fcr, what I wrote was, and stand by, is that their remissions are not as durable as mutated people get. That is proven. Ibrutinib works well for both unmutated and mutated. That is proven as well. Over 90% of first time ibrutinib users, in a small trial, were progression free 5 years out. That’s a longer remission, on average, than unmutated fcr folks are getting and without the risk of marrow damage and increased risk of secondary cancers.

There might be practical and financial reasons to enter a trial. As I also wrote, I can’t speak to the availability of drugs in the UK and if you don’t have access to ibrutinib frontline, then the trial makes more sense.

My research as I considered fcr as a frontline treatment told me some top Cll experts do not use chemo at all anymore. The majority still thought fcr was a good choice for young, fit and mutated people. Most doctors have moved away from fcr for unmutated patients. They get better remissions on average with ibrutinib without the risk chemo brings.

My doctor is largely credited as being the founder of fcr. He has me on ibrutinib which was also recommended to me by the head of the Cll dept at the Natl Inst of Health. It’s working well for me, so I have that built in bias.

My local doctor recommended fcr at first, then agreed ibrutinib better. I do think the choice for first treatment is something over which reasonable minds can differ and that some very smart doctors around the world, way smarter than me, still use fcr frontline for unmutated patients. That said, I think there is a strong trend away from fcr, particularly for unmutated patients.

Dan, if top experts can disagree, it’s natural you will get conflicting opinions on a message board. If you have a very good Cll doctor who specializes in Cll that you like, I would give great weight to his or her opinion. It sounds like a wonderful trial. My opinion, over which reasonable minds can differ, is that I would not want to be in the fcr arm of that trial. People are getting deep remissions with the I/V combo. That would be the arm of the trial that excites me most, but you might not be able to find a trial that guarantees you that choice. I think the trial you are considering is a reasonable choice, particularly if ibrutinib is not available to you front line.

I wish you the very best in your choice. I think you might do well in any of the arms you are assigned to, including the fcr arm. Our Cll is so different from person to person, there is no one size fits all treatment.

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What you are saying about the relative effectiveness of FCR vs Ibrutinib is not so much the issue as the fact that many members of this community just can't access Ibrutinib. Please be considerate about how your replies impact members who are in this position. In the UK, at least there is a possibility of gaining access for a portion of those entering the FLAIR trial by random assignment, but that's not the case in other countries...

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Thankyou so much for the reply,I have learnt a lot from them.They have only offered me this trial or the fcr, I will go with the trial now,as that seems the best option for me.I will fill the forms and let the computer decide.once again thanks to all for your replies

Regards dan...

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Good luck Dan. We will all be rooting for you! Let us know how you get on.

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Neil, I must be an a very bad communicator if my posts come off as inconsiderate. I was only trying to give honest feedback as I just went through myself having to make the difficult choice of my first time treatment. I admitted twice I don’t know about access to drugs in the U.K. and how that could be a factor.

The las thing I ever would want to do is come off as being inconsiderate to a fellow Cll-Er, you know I have cancer too. My apologies to Dan and whoever was offended by my input, it sincerely was not my intent. I will stop posting on your forum . I thought I was giving honest and respectful feedback. Evidently not. My bad. Best of luck to you Dan, I am truly sorry if my input offended you in any way.

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Hi bassejm, there’s absolutely no need to stop posting and Admin have no wish to deter any fellow CLL’ers from giving or receiving support.

The comments made to you are simply a request to consider your advice in context because it’s quite possible to make a member feel they are failing themselves when the choice is no choice. Clinically you make sound points but like myself, who is probably nearing treatment, the Flair trial offers the only opportunity to access non chemo options. My mutational status hasn’t even been ascertained but probably would if I was accepted for Flair.

This site is an international one and sadly, some of our members from even less medically advanced countries struggle to get treatment beyond the basic and indeed the primitive in some cases. It’s a dilemma to be made aware that a certain course of treatment may not offer a durable remission when there’s no alternative. Clinical agreement does not always equate to resource availability or political will I’m afraid. Dan’s decision is the best he can make in the circumstances.

Regards,

Newdawn

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Please continue to read and post bassejm , you were doing your best to assist someone else and were indeed respectful in your reply. It's unfortunate that, in this international community, we do not all have the access to drugs that you have.

You are well informed and i look forward to seeing your comments on other posts.

Jackie

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It's a common misconception that what we have available to us where we live is available everywhere. Reading the experiences of those seeking treatment in other countries is the best way to become aware of the differences, which are constantly evolving in any case. We ALL need to be sensitive to how we may make others feel by encouraging them to enrol for treatments just not available to them and thereby dealing them an additional blow of feeling further unfairness of life after their cancer diagnosis. We try to encourage members to include their country in their profile or username, but sometimes you just have to read what they have posted.

No one has asked you to stop posting, just to try to respond with information more relevant to the person concerned - just as you would appreciate.

Neil

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Thanks to the administrators for the input. I think it best I take a hiatus from posting on your forum while I learn the ropes. The very last thing I ever want to do is to be inconsiderate of a fellow Cll-Er. I thought I had qualified my answers by writing I don’t know about access and financial considerations. The public rebuke I got caught me quite off guard.

It’s a great forum you guys have and I imagine the administrators are all volunteers who give their time to have a place where we can share information. That is much appreciated. I will continue to follow the forum and hopefully return to posting after I learn your rules better.

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Please don’t stop posting. Nobody was offended I promise.

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Adrian, no worries. We are in it together.

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Don't stop posting bassejm . Your comments were in no way offensive.

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Neil, prior to getting publicly admonished by you for being inconsiderate, I had included in my answers to Dan in two separate posts the following:

"Yes I really cannot comment on the insurance and UK issues, just about what treatments are best".

And then again:

"There might be practical and financial reasons to enter a trial. As I also wrote, I can’t speak to the availability of drugs in the UK and if you don’t have access to ibrutinib frontline, then the trial makes more sense".

So in my simple mind, I thought I was qualifying my opinion on the trial and Dan's choices by the fact that our choices can be influenced by access and also financial considerations.

Choosing your first treatment is hard, I just went through it, and had to sort through all sorts of conflicting advice, and I always appreciated those who took the time to give me their input.

If I over stepped the boundaries of your forum, a private email would have been nice as opposed to some public admonishment that paints me to the community as someone insensitive to my fellow cll-ers.

So I will just leave it at that. Dan has my apology and i am sure he knows if I was insensitive, I was trying to help. I am not a doctor and clearly not an expert, so I think I shall watch and read and avoid giving input that others might find not helpful.

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One last question,sorry to pester people,do I take it that with the fcr treatment, you have your treatment and that's hopefully it for a while,my nurse said with that possible blood transfusions may be needed.with the trial,you have to go to the hospital every week for tests? ,is this for the whole period of the trial.

Regards dan

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With the trial you have a CT scan and bone marrow biopsy prior to beginning and a few during depending on the protocol of which treatment your taking.

You’ll only have blood transfusions if needed up until the point your therapy clears the Cll cells from your marrow and your HGB recovers.

There’s generally a bit of close monitoring in the beginning to ensure the treatments working but as long as all’s well usually just a three monthly check up.

Stuart

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Hi ok that does not sound to bad,I had visions of having to go in every week for years on the trial.

Regards dan.

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Do the trial and hopefully you get # 2 or # 3.

You can drop out if you do not get the arm you want.

Study Dr. Furman and Dr. Kipps on Youtube.

CLL Society web site has very good information as well,

Be well,

Hoffy

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OK I'll check that out,thankyou for your advice very helpfull

Regards dan.

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The above comment by Hoffy doesn’t make any sense.. if you drop out of the trial due to not receiving either of the targeted therapies you’ll still have to accept FCR as a frontline..

Remember if your assigned FCR and it doesn’t suit you for example you have a bad reaction it’ll be stopped and then you’ll be given Ibrutinib as a second line therapy in line with the new NHS guidelines.

Stuart

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I really think thAt we shouldn’t go into flair with the idea of dropping out of an arm we don’t like immediately. Since that would affect the results. In any case what would we drop out to? It is of course allowed. But shouldn’t be encouraged in my view.

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Http://www.cllsociety.org is the link.

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True, fortunately 2/3 of the trial is targeted therapy so the odds are pretty good already,

I am told many trials have a tough time filling up many times though...

Be well,

Hoffy

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In the U.K., for now, yes, you could drop out of the trial if you didn't like the arm you get. Most people who sign up for the Flair trial do so hoping to get one of the newer non chemo agents. If they don't, as was said above, their only option is FCR. If randomized to FCR in the trial, one has the advantage of very close monitoring, that patients not in the trial wouldn't get.

If I were looking at things, given the reality of the medical system in the UK, I think I would go for the trial. I don't think that those of us in the US can fully understand the limitations of health systems in other countries, any more than those patients can understand the frustrations of dealing with our insurance systems. We need to answer questions in context, or ask questions of our own about what the context is if we don't know.

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I don't know why this is getting so much hand wringing. If you don't go into the trial, the only choice in the UK is essentially Chemo- FCR, if you are untreated.

If you go for the trial and get randomized to the Chemo arm it's the same medicine, so why drop the trial? You get the same drugs either way, and probably better medical support in the trial.

Len

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In a clinical trial even with FCR , you get better/closer following, more advanced testing in many cases the name of a trial nurse to talk to in the rare event things go sideways....

I think there is a moral commitment for those entering trials, to stay the course, no matter which arm is selected ...

~chris

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Absolutely agreee Chris. But one thing a lot of people don’t realize so it’s worth saying is that part of any trial is that if a treatment arm doesn’t work for you they will drop you out of the study, you have contributed the data the study needs, and then they will give you treatment as per regular practice. So in the uk if FCR wasn’t working for you in FLAIR you’d drop out and go onto ibrutinib

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I agree with that logic.

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Chris,

But what if you enter the lottery to get a shot at a winner and the other arm is not a good option? If you lose the lottery your choice is either soldier on or potentially buy another ticket to something else if available.

I get the moral point but who really knows what the right decision is in the end.

Jeff

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I agree Jeff, but that is why trials must be selected carefully... if there are a number of them.

However, in the far flung reaches of the world, like the UK, Europe, Canada and Australia, there may only be one CLL trial patients are qualified for, maybe two, very rarely three...

Patients in the U.S. and Germany have no idea how fortune they are to have an abundance of clinical trials to choise from... its an embarrassment of choices....

And still the percentage of patients entering clinical trials is abysmal. I recall a figure of 6% in CLL but can't confirm it.

But then there is the age factor, access, transport and costs... which all should be considered and weighed.

Clinical trials aren't for everyone...but we need to do better.

~chris

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I agree Jeff, and in 2012 I looked at the Ibrutinib trial vs. the Idelalisib trial and chose Idelalisib because of a crossover option. The Ibrutinib trial had a lousy comparator arm and no option except leave the trial and get Chemo.

But in this UK case, the trial is the only NON chemo option for untreated, and 2/3 of the patients get targeted treatment the other 1/3 have Chemo - same as non trial untreated.

As Chris says- not many trial choices in UK.

Len

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I understand. I guess a persons perspective is what do they see when they look out their window.

I see choices now but a few years ago, even in the states, they were chemo or idelalisib or Ibrutinib. Sometimes, lenolidimide. Fortunately, the landscape has improved for me. I get it now.

Thanks,

Jeff

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