Acerta trial

[Yidarmy69]

I’m being assessed for this trial but if I get put on 3rd arm fcr can I decline and go on flair trial I don’t want chemo

[AdrianUK]

Honestly I don’t think that’s a very honourable way to go about it. And I suspect that any doctor who realised you’d done that wouldn’t invite you to enter another trial. What would you do in the second trial if you got the FCR treatment then? You would actually be baising the results of the first study as your data would have to be seen as a chemo patients data.

Also bit confused as the company you mention is not using chemo inn their trials as far as I can see obinituzimab isn’t chemo and just so you are aware FLAIR is UK only seee acerta-pharma.com/pipeline/

We enter study’s not just to benefit ourself but to benefit future people with CLL as we have been benefited by those who r gone before. Not everyone has to go through a trial. But those who do so really ought to make the best of whatever treatment they are allocated and if there is an arm they really don’t want to receive don’t volunteer for that study.

Ironically in FLAIR the word on the street is that ibrutinib alone is almost never getting people to undetectable status but I’ve heard of a number following the full

FCR protocol to six sessions actually getting to MRR undetectable. I managed that even with being unmutated. And I was randomised it in FLAIR.

If you believe that random choice is not random you can pray and ask God if you Believe in him or the universe itself to give you what is best for you as an individual. And because it is unbiased and we don’t know what the best treatment is the computer is our best chance of getting the right treatment for us.

What are the arms you might get?

[trenaleigh in reply to AdrianUK]

Please just give your answer without making someone else feel bad or more confused. This disease is tough enough. Show understanding or please stay quiet. Thanks.

[AdrianUK in reply to trenaleigh]

The thing is, what this person is suggesting risks biasing the results of the clinical trial and therefore damaging the future for all of us. As hard as it is to consider that we might have to take chemo, actually chemo is an effective treatment that some people in other parts of the world who can’t get ANY treatment would be so grateful for. And so I really don’t think it is unreasonable to suggest that someone who is thinking about volunteering for a trial should think carefully about whether or not they are willing to take every arm of that trial at the beginning.

Sometimes the arm you don’t want turns out to do well for you. I faced this myself in being randomised to FCR. Some people on here said that as someone who was unmutated I was making a terrible mistake letting them give me that. But it turns out that FCR gave me a complete response with MRD undetectable ie cancer cells less than 1 in 100,000. Hopefully I’ll not need more treatment for several years.

Trials are meant to be between options that we don’t yet know which is the best. Nobody is forced to go into a trial. But we do trials not just for our own good but the good of everyone.

I totally understand how stressful it is facing treatment and that choosing what treatment to have is really hard.

[trenaleigh in reply to AdrianUK]

I’m sincerely happy that FCR worked well for you. In fact I’m grateful you had success. But the truth is that isn’t always the norm. Many in our situation have hurt their bone marrow so badly that other treatments aren’t an option. Watch and wait originally began because treatments were worse than waiting so the bad reaction your body may have from a treatment did not happen.

It makes perfect sense that a person going into a trial may have their own guidelines for many reasons. One being they don’t feel strong enough to handle all that they are contracted to go through. Extra tests and radiation. Medicine causing tumor growth lysis(sp) or worse. We have a disease but should be respected enough to choose what is put into our bodies. Not for a report that in my opinion only helps a few while giving power to the companies in charge. Not even to the doctors.

Additionally, this site is for kindness and affirmation being in this together. If we are not here for each other then who will be? If someone has genuine fear, it shouldn’t be discounted. All of our needs and opinions are important and valid.

[schmitthj007 in reply to trenaleigh]

I understand Adrian’s and your point. Trials are difficult to conduct and recruitment equally in all arms is at times difficult based on patients preference and preconceptions. The trials conducted are comparing different treatment options and presently we do not know which option is the best. I believe it is the responsibility of the study coordinator to explain this to patients. Any trial that includes options that are clearly inferior would be unethical or needs to be stopped should one of the option becomes inferior during the trial. I wished none of us would have our biases and preferences and could overcome our anxieties knowing that we truly do not know which option is the best. But we are fragile humans. We have the option to opt out of a trail at any time and this is for good reasons and this at times happens. A trial should be conducted and designed in such a way that the results are still meaningful and help future generations. I am in a phase 2 trial with venetoclax acalabrutinib and obinutuzemab and hope it is as good as FCR which was an option for me. Time will tell and there are presently phase 3 trial available testing this option. I would encourage many of my CLL fellows to participate in trials if they have the option but understand if they opt not to or withdraw consent while in a trial. My experience so far has been outstanding despite some bumps in the road. Wishing you all the best.

[trenaleigh in reply to schmitthj007]

Yes, I do agree with you and understand it’s a personal choice. My concern is the lack of information given to some patients because clinical trials are recommended and even pushed on some of us by doctors. Is it for our Benefit? It takes a while to understand this disease while trying to overcome it at the same time.

When it comes to Chemo....... all bets are off in my opinion. It is less expensive to provide and in many cases damages our inferior bodies and immune system. Our bone marrow is affected and I’ve heard of people who don’t bounce back when our bone marrow is key to our survival. I can never willingly tell one of you that chemo is an option. We don’t have acute or myeloid. We have chronic CLL.

[MelioraDay]

You have every right to decline any treatment at anytime. You need to do what you believe is right for you in consultation with your health care team.

[Jackpot]

I am also being considered for this trial. My dr said if I get the third arm (chemo) I could drop out and go straight to ibrutinib. I told her I would feel like I was signing up in bad faith. She said absolutely not. Go figure.

[AdrianUK in reply to Jackpot]

Just imagine if every participant did that. The trial would then be totally ruined. If you’d rather go for ibrutinib monotherapy then it sounds like you could get that anyway outside of the trial without being randomised? Am surprised to hear a doctor actively suggesting this approach.

[nozha13 in reply to AdrianUK]

The trial would not be ruined and they would just move on to the next participant. You should all stop being so preachy and opinionated when it’s not you facing the prospect of chemo.

[GMa27]

I had 3 rounds of FCR and reached remission. Doing great and my chemo was uneventful. Recommend second opinion.

[MsLockYourPosts Passed Volunteer]

I agree with Adrian that one should consider whether the terms of a trial are acceptable to you personally before agreeing to them. I have stated in the past that I personally would have to look long and hard at the terms of a phase three trial, and find that I could live with whichever arm I was assigned to. I know that I would not be comfortable having a computer make the decision for me if I was uncomfortable with one of the arms, and I don’t believe in making commitments unless I plan to follow through. I hadn’t considered that backing out of one trial could affect your ability to enter another, but I’m sure that, at least in some cases, it could.

If you are in the UK the Flair trial is inviting as it gives patients a two in three chance of being assigned to a treatment other than FCR, which would be the only choice outside of a trial. In that situation I would probably opt for the trial. I am not familiar with the trial you are considering. I believe that you have the right to discontinue participation in any trial at any point in the trial. I would discuss all of this with your doctor, as he/she would be in the best position to advise you about the possible consequences for you if you do decline to participate in this trial based on the arm you are assigned to.

[Jonquiljo]

I agree with you, Yidarmy69! You have a first responsibility to yourself and not to be honorable. If you cannot get novel agents except by clinical trial, then go for it!

I know my advice seems "seedy" to some people, but we are talking our choice of treatment of a life-threatening disease - and we (ourselves) are the ultimate person to determine the course of our treatment!

The bottom line is, despite the country we live in, our medical systems do not bend over backwards to take care of us. We have to take care of ourselves somewhat.

For instance, I live in the US. While many novel agents are available to us, lots of us are prohibited by pricing to actually use them. Whether we pay homage to Abbvie, our governments, or ourselves is really an easy decision. It's not a fair world and I firmly believe we must do whatever it takes to be fair to ourselves.

If we were each wealthy we could bypass the system and do whatever we wanted. That's not fair either! Would it be wrong to say, "I used my trust fund to get Ibrutinib because that was the only way I could get what I want?" No.

It's an arbitrary game everywhere and we do what we can to survive.

[trenaleigh]

You don’t need chemo if you don’t want it. There are many options now and you don’t need a clinical trial either. Of course you should go over all of your options with your doctor. I don’t know your blood make up, mutations or if you’ve already had treatment? But I do know you don’t have to have chemo. It actually can hurt your bone marrow and with so many other options, you have every right to question it. Yes, trials help others but mostly the drug companies. You need to do what is best for you. You should always get a second or third opinion. I did and am grateful I didn’t listen to my first doctor. This disease isn’t like many others and you should make your own decisions especially when doctors have their preferences. This I have no doubt about that it’s your choice. This disease can be confusing but usually you have time to try options first that you alone are comfortable with.

[claree_ford]

It is tough. You do have to do what you and your doctor think is best for you. I do agree though that if you enter a randomized trial where it is not known which arm is “best”, then you stick with it. My view would be think long and hard before signing up, but once you have, you are committed to it. A bit off subject but it colours my opinion - forty years ago my youngest brother died from Hodgkin’s lymphoma (not CLL of course, but part of the same family). They tried every treatment they could to save him. Some very experimental. He actually died from the treatments rather than the disease. And they (they? Doctors? Pharmacological companies?) learned. From him and many others. I understand that Hodgkin’s lymphoma is often controllable these days. I don’t know if I would be brave enough to go into a trial. I hope, if I saw say a lorry bearing down on a child I would be brave enough to leap in front and push them clear - maybe I wouldn’t - never been in that situation - but it doesn’t seem that different really.

Right, that was my stream of consciousness, not trying to tell anyone else how they should feel or what they should do, just my two pennyworth of opinion.

[Big_Dee]

Hello Yidarmy69

If you are so against chemo, what are you going to do for treatment if you drop out of trial? Big decision, I know chemo sounds scary, I chose B+R, but could have done ibrutinib. A lot of factors in your decision. Blessings.

[CLLCalifornia-USA]

Yidarmy 69,

Only you and your doctor will know what’s best for you. I’ve had FR, BR and now Ibrutinib. No way in hell do I want to relive my chemo days. For me BR was so severe I wasn’t sure I was going to live through it, and yet for others it is less of a problem and works great. At the time, chemo was all that was available. I was lucky that Rituxan had just come onto the scene. Don’t feel guilty about your choice. You are fighting to live and there is nothing dishonorable about that choice. It’s sad that our healthcare system doesn’t always give good affordable choices. Best of luck. You’re in my prayers. Sally

[Yidarmy69 in reply to CLLCalifornia-USA]

Thank you for your kind words I’m very grateful

[Hoffy]

You perfectly have the right and do what you feel is best.

Be well,

Hoffy

[PlanetaryKim]

It's your body and you always at any stage have the right to say no to anything being proposed or done to your body. And you have the right to pursue whatever path looks like your best option at the time to get what you are trying to get for yourself.

[Yidarmy69 in reply to PlanetaryKim]

Thank you for your kind words hoping to start trial in September if all goes well

[PlanetaryKim in reply to Yidarmy69]

Good luck!

[nozha13]

I am on this trial - one month now and got randomized to Arm A which is acalibrutinib and venetoclax. I would have dropped out had I been randomized into the chemo arm. I would ignore the posts that proselytize to make you feel guilty about taking the option to drop out. It is your right to do the best for yourself and to choose novel agents that could benefit you without harming your DNA. No one should be told that they should sacrifice their health for the purpose of research. Good luck to you.

[Yidarmy69 in reply to nozha13]

Thank you for your reply I will do what I think is best for me I really hope you are doing well on this trial with out to many side effects

[oztrader in reply to nozha13]

Totally agree with you nozha13.

It's my decision always and wouldn't feel guilty in anyway at all sorry not interested in that BS.

I am on a One arm Trial using Acalabrutinib . Dr wouldn't except me for the Three Arm using A V O & Chemo because of my age etc but I was happy that I may have been selected for the Non Chemo arms if had lost the lotto roll would have declined Chemo anyway .

He said but we do have other trials that would suit you. So I chose one I studied a lot about .

Overall very happy with it and that it's Non Chemo.

[nozha13 in reply to oztrader]

Wishing you the very best of luck and good health!