Having to re-sign for the FLIAR trial as Ibrutinib producing high than expected blood pressure

[zaax]

The local FLAIR organiser just phoned say that the FLAIR trial is finding that Ibrutinib is giving more people higher blood pressure that predicted (above 10%), and I have to re-sign the FLAIR agreement.

[fapumpkin]

This is very interesting as I rang the Flair trial nurse at my local hospital and they seem to have no knowledge about resigning/re-consenting? I am unsure if I will carry on with the Flair trial as I only opted to take part as I was so concerned about FCR potential side effect of Peripheral neuropathy, which I was diagnosed with over year ago after numerous falls, at the time I had been treated with ibrutinib for nearly 4 years. I am now aiming to find out if there is an alternative as I can not face the peripheral neuropathy getting any worse or affecting my hands. I looked up the Flair trial and Ibrutinib on the following

cancerresearchuk.org/about-...

"The most common side effects of ibrutinib are:

a drop in blood cells causing an increased risk of infection, bruising and bleeding

high blood pressure (hypertension)

diarrhoea or constipation

tiredness

feeling or being sick

cough

swelling of your hands and feet

skin rash

high temperatures (fever)

dizziness

painful joints and muscles

headache

shortness of breath

tummy (abdominal) pain

loss of appetite

indigestion

sore mouth

nerve damage causing weakness, tingling, numbness and pain in the hands and feet (peripheral neuropathy)

skin infection

sinus infection (sinusitis)"

[Jm954 Administrator in reply to fapumpkin]

I also have some peripheral neuropathy from Ibrutinib and I'm obviously not happy but it only affects the toes on one foot and has not got any worse over the 3 years I've had it. I'm nearing 6 years of Ibrutinib treatment in FLAIR and consider it a small price for the control of my CLL. Yours does sound worse than mine and something to discuss with your haematologist so that you can make a fully informed decision about what action, if any to take.You can elect to leave the trial at any point and your treatment will stop. It is likely after four years of Ibrutinib that that you have a very good remission so no alternative treatment would be offered and you would resume watch and wait until you need treatment again under the relapsed arrangements.Jackie

[fapumpkin in reply to Jm954]

Thank you for the advice - I am hoping to get some clarity from my next haematology phone consult mid March - wether the peripheral neuropathy will increase/stay the same & whether duloxetine could possibly resolve or improve things, I understand that it may be a big ask & might involve other medical input. the peripheral neuropathy in my feet has caused quite a lot of falls (one involving a head injury and an a&e visit) which is an issue with my treatments for osteoporosis, I already have 11 compressed fractured vertebrae (no falls involved) so it is a real concern. plus my work involves fine crochet which is why I wanted avoid FCR as any neurological damage to my fingers would really affect quality of life.

[Jm954 Administrator in reply to fapumpkin]

I’m sorry to hear all that. I hope they can sort something for you

[Jm954 Administrator]

The cardiac issues such as high blood pressure and atrial fibrillation are higher than expected when the trial was started but that is the point of these large scale trials.

The re-signing is just to say you have been informed of the risk and wish to continue in the trial. For those on the targeted treatments coming out of the trial will mean cessation of treatment so the risks and benefits need to be carefully assessed. It would also mean the end of the MRD measurements and trial monitoring.

As an extra precaution, in the near future FLAIR Ibrutinib patients will also be offered an echo cardiogram, a type of ultrasound to look at how well the heart is functioning.

For a minority of patients the cardiac issues may be significant, for the majority though Ibrutinib will give them excellent control of their CLL without the risks associated with chemotherapy.

Patients enter trials informed that the experimental treatments may throw up unexpected issues and patients following on are grateful for those that have paved the way for these new treatments by their participation.

Jackie

[Newdawn Administrator]

I’m waiting to hear about a possible re-signing of trial agreement but have developed some issues that I’m awaiting cardiology investigation of. I don’t want to elaborate on an unlocked post but I can appreciate the difficulties this could throw up for some participants.

Newdawn

[NooNoo14 in reply to Newdawn]

I had a phone call yesterday from my Trial Nurse to say that the form is being sent out to me to be signed and that an echo cardiogram is being organised. I am guessing that I have received this early as I already had AFib when I started the Trial 3 years ago and became Permanent on starting Ibrutinib. My heart is checked on a yearly basis by my Cardiology team and, as far as I know, has not deteriorated thus far. I take a Beta Blocker and a blood thinner.

This won’t be an easy decision for me. Do I risk damaging my heart or carry on with taking a drug that, despite the many side effects that it gives me, is working and with no other treatment currently offered by the NHS, go back onto W&W!

Netty

[Newdawn Administrator in reply to NooNoo14]

A difficult situation for you Netty 🧐

Please let us know how it goes once you’ve had the tests and pondered on the situation.

Newdawn

[NooNoo14 in reply to Newdawn]

Will do Newdawn. You take care.

Netty

[JT67]

Hello Zaax, I am not sure which hospital you are with but I was sent my form a few weeks ago. I was told I should sign it in the presence of my consultant, which I duly did a couple of weeks ago now, as the alternative is coming off Ibrutinib, which seemed more risky than the risk of heart trouble at the moment for me.I wish you all the best.

John