Hi I am about to complete the Flair Trial, having completed 6 years on the ibrutinib and rituximab arm in March 2024.
I have decided to follow through with the Static trial where patients will be either off or on ibrutinib.
The purpose of this trail is to see if giving patients a drug holiday prevents or reduces resistance to ibrutinib. If treatment is needed they return to ibrutinib.
Patients on ibrutinib can choose to remain on it and still be part of the trial, or let the computer decide for them through randomisation.
Initially I thought I would choose to stay on the drug as it is working well for me right now. Now I am pondering with randomisation as it may work well for longer if I am allocated a break Do I stay with the devil I know or take a risk?
I feel blessed to have been on the Flair trial and doubly blessed to be offered Static.
I wonder if anyone else is or has been in the same position as me?
If so I wonder if you are willing to share your experiences or views on the subject?
Ann
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annmcgowan
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You make a good point in your second reply Jammin. They may discover that removing the drug starts off resistance rather that stopping it. There are a few questions I need to go over with my consultant, that will be one of them.
Ann, since it is working for you, I would probably stay on it. Can they test for UMRD? I would only probably go off if I got the UMRD result. Otherwise I would stay on it until it fails.
Thanks poodle 2, I am moving back in that direction. They test for UMRD once a year and I still have not reached it yet. That’s not surprising as ibrutinib is a drug used to manage CLL not cure it. Some people have reached UMDR but not many. I am just a smidgen off it.
Hi thank you for your response. I have always wondered if it would be better or an alternative at least to reduce the dosage rather than stop the drug altogether. This is a question I will take to my haematologist when we next meet. Maybe this should be trialed too!!
I was on the Flair Trial from 2015-21. In 2021 the Static Trial was being put together and my initial thought was to join, being so grateful to Ibrutinib coming along when I needed it and wanting to play my part in a trial. However, the Static Trial was then delayed and this gave me more time to consider options. When introducing Static, Professor Hillmen in February 2021 said the “life-long” use of such drugs as Ibrutinib can create some problems, such as the emergence of side effects over time and the risk that the CLL develops resistance to ibrutinib. Continuous ibrutinib may not be the best approach and there is evidence to suggest it might be better to give drugs such as ibrutinib intermittently. To my mind this meant stay off Ibrutinib for as long as possible, so don’t risk the trial and the chance of being randomised onto continuing Ibrutinib. I talked to my Consultant who assured me that, when I next needed treatment, I would get whichever drug was most suitable for me, and she pointed out that there may well be, for me, better options than Ibrutinib available by the time I next need that treatment. So I opted against the Static Trial and 28 months on I remain treatment free, and I’m aware that new treatments are becoming available.
Thank you that’s an interesting choice. Prof. Hilman did say this so I understand your thinking and decision. I am happy to hear you are ok 24 months in, that’s good news for all. Are you aware of the evidence that supports drug holidays?
No, not aware. I don't have any great knowledge in this area. But my layman's logic tells me that cancer is clever and will be working on ways to get round the drugs. That logic, rightly or wrongly, makes me think that the longer the same drug is used, the more opportunity the cancer cells have to build up resistance. Treatment pauses and changes of drugs will, hopefully, make it harder for that resistance to develop.
I understand zaax I am in the same position as you. Your post prompted me to re read all replies I received. It seems we both need to look at alternatives on the NHS now to make a decision and discuss with our consultants. Mine isn’t pushing me either way but giving little clinical advice in terms of where he thinks I should go. I am going to push him further at next visit. I will let our community know the outcome when I do reach my 6 years in March. Good luck to you keep us informed of how you progress.
My dad was on the same arm of the FLAIR trial as you. He stopped Ibrutinib in February 2021 and has not needed treatment yet, although there has been an increase in white cells over his last few appointments. It’s difficult to know what to do for the best but we are very pleased that Ibrutinib has allowed him to be treatment free for over 2.5 years now.
Thank you. You are doing well. Long May it continue. Can I ad you, If symptoms return, god forbid, Will you go back into ibrutinib or another treatment?
This is such a tough decision and being on the Flair Trial, one I understand to some extent. I’m 4 yrs into the trial and was randomised to the I&V arm. I reached uMRD and thankfully that position has continued. I had to discontinue Ibrutinib after 15 months due not to its failure but rather bad side effects. I developed severe arthralgia and myalgia. I continued successfully on Venetoclax as part of the trial.
When I read your dilemma, I considered what I might do in that situation. Clearly you trust ibrutinib and it’s served you well in achieving a maintenance situation. It’s a good place to be with CLL. However, the Static trial offers no guarantee of continuance and I’d rather manage the gap period than waiting it out. If you find that by discontinuing ibrutinib, you start to regress in some way, there’s now more effective treatments available including next generation BTK’s and targeted drugs. Venetoclax for example which could possibly effect full uMRD for you.
Part of me would be slightly nervous of long term Ibrutinib but I can’t quantify the risk and that’s the difficulty. It’s a conversation for your specialist.
Thank you Newdawn. Glad to hear you are still doing well, long May it last.
I feel my haemotogist is reluctant to commit either way. He wears two hats clinician and researcher which doesn’t help. He responds to my dilemma at length without indicating what he thinks I should do as my clinician. This throws the ball back into my court. He may well be throwing out hints, if he is I am failing to pick them up, which is why I choose to turn to our community for support.
I have great faith in him, he has been exceptional doctor and looked after me well to date. I think I need to tell him how I feel and push for some clarity from him.
Hi Newdawn I have just re read all replies I have received to my post . I was unsure about what you meant re static not offering any reassurance of continuance. Did you mean continuous on ibrutinib? If so it does that’s my dilemma, it offers me the choice to stay in or be randomised to off or on. It was originally rand randomisation only now you have a choice aspect.
Yes that’s what I was meaning Ann. Sorry if I wasn’t too clear. It was the recognition of your dilemma because it’s hard to make what is a clinical decision not knowing the full implications of long term Ibrutinib. In my case it would be simple because I experienced some of the toxicity elements of the drug including severe tachycardia for which I’m now on long term beta blockers. I wouldn’t be offered Ibrutinib again should I relapse. Ibrutinib did work for me over 15 months and I’m not resistant or refractory to it but for me the toxicity profile is a concern.
However it’s worked very well for you and I understand the temptation to continue with what’s working. It’s a scary prospect to stop the Ibrutinib with no guarantee of remaining stable and it doesn’t help that it’s being thrown back into your court to make the decision. You can’t be expected to quantify the risks around continuance in terms of resistance and side effects and need guidance on this.
I hope you can receive some greater clarity from your clinician. The important thing is that whatever decision you make, a range of treatments are now available going forward.
Hi Newdawn thank you for clarifying for me and the understanding you have shown regarding my dilemma. I do need to push my haematologist a bit more and will be doing so. I will let our community know the outcome and my choice.
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