What to do?

[SandiC]

Hi all,

I have a decision to make and would like your feedback. I read the posts regularly but don't post much.

So,

I was diagnosed with CLL last year 6/15 at age 65 (though I suspect it really started around 2009 when I had a slightly elevated absolute lymphocyte count and a swollen lymph node in my neck. I live in the Washington, DC area and have had all the tests and then some. I have been to my local hem/onc; Georgetown, OSU (John Byrd) and NIH.

I am complex karyotype headed by 11Q/ATM; negative for 17P and TP53; CD38+, ZAP70+, NOTCH 1+, unmutated IgVH, etc. My blood work isn't awful (pretty much just high wbc, lymphs) but I have lots of lymphadenopathy inside and out with wierd neuralgias, am very fatigued, and have night sweats . Dr. Byrd feels it is time for treatment and so do I especially with the complex karyotype.

My choices:

1. Acalabrutinib clinical trial at NIH - easy peasy and no cost at all. But I would have to stay on acalabrutib until I relapse/resist/etc.; or

2. Triple clinical trial at OSU (Byrd) for obinutuzimab, Ibrutinib and Venetoclax for 14 months. We pay copays on Ibrutinib and whatever medicare and supplement doesn't pay for treatment/tests/lodging/transportation/etc. At the end of 14 months, we can try to discontinue all treatment if good response.

The dilemna: My prognosis isn't great because of the complex karyotype (Dr. Byrd says this trumps 17P). Dr. Byrd feels either choice would be a good choice for me but ever so slightly favors the OSU triple.

I know acalabrutinib will not "cure" me but would be easy as I live 40 minutes from NIH and the trial itself as well as the side effects should be no biggy and can buy me time for the "cure"

The triple would be a very tough 14 months commuting back and forth to Columbus (and the costs involved), and the side effect profiles of all 3 drugs scare me. It is also very early in this study. I believe that combo treatments might be the future "cure".

Quality of life is really important to me as I have "almost" 4 young grandkids who I adore. My gut is telling me to go for the acalabrutinib to buy time until these combos have more results and have been tweaked. I must admit that I may be a bit risk adverse.

So what do you all think?

Thanks so much for your input,

Best to you all,

Sandi

[MsLockYourPosts Passed Volunteer]

Wow! That is a tough call - one I'm glad that I don't have to make. There are good threads on cllforum.com with patients posting about their experiences with both options. I would throw your question out there with a title /subtitle naming your options. Reading through the experiences of others in the OSU trial and on acalabrutinib might help you find some clarity. I suppose that the good news is that Dr. Byrd feels that either choice is a reasonable one. Keep us posted.

Pat

[SandiC in reply to MsLockYourPosts]

Thank you, will do

Sandi

[Aussiejock]

Hi Sandi,

Your Circumstances and diagnosis are very similar to mine. Plus your family first with grand kids is also the same as what drove me to pick a treatment. Actually I am currently in hospital day one of treatment I had rituximab today and adding bendoamustine tomorrow.

If you click on my name and read my posts you will see the process I went through the to make my decision. The issues Imhad was most of the newer drugs are not available on subsidy in Australia and even the clinical trials are looking at relapse, hence in consultation with my specialist Br was chosen to give a window of quality of life and the. Be eligible for the newer drugs at a later date on relapse and hopefully the manically cure.

One of the issues I had was Ibrutinib is a daily does for a long time with side effects. Br predominantly is a 6 month plan to normality, all going well.

I wish you well with your decision. I am happy to,step through any questions you have on my decision making.

[Jackistired in reply to Aussiejock]

Aussiejock

Ibrutinib is first generation drug. Acalabrutinib is 2nd generation drug, it is a different drug with a much lower toxic profile & fewer side effects. (also only available to those who can get in clinical trials)

[SandiC in reply to Aussiejock]

thanks much and good luck with you.... keep us posted and I will too

[Que-sera-sera]

Hi Sandic,

I feel almost like ..how dare I? To even venture an opinion since it's such an important decision, (btw, I'm 17p delete getting close to needing treatment myself) but just personally I feel I would want to start with "Door #1" Acalabrutinib and see how that goes first and hopefully in the meantime there will be better data on the Venetoclax trials and/or other possible treatment options. Wish you the very best whichever way you decide, I'm sure by tomorrow though, you will have a lot more feedback to consider.

God Bless.

[SandiC in reply to Que-sera-sera]

thank you and best of luck to you as well.

[tekusa]

Hard Choice.... I live near NIH (go there as well....from Phila area) and See Dr Byrd as well (fly out). Seems that if you do the Combo Trial you skip the waiting....... (possible cure). After all if the combo gets approved by FDA you will have to pay then. Of course once approved you get the treatment close to home not at OSU, still would be expensive. Problem is it will take few to five years to get approved (I am guessing).

I am wondering if the same trial will be done at NIH? Did you ask? Seems like a logical combination BTK for Lymphnodes and BCL2 for Bone Marrow = Complete Remission. We Hope! My instinct says go to OSU for combination trial and drive out in your car and rent a place in VRBO or something. At least for the first 4 to 6 months. Best Wishes to you. Dr. Byrd is such a good CLL doctor and this combination with Dr. Jones might be the ticket to a long remission... MRD negative maybe.

[Jackistired]

I would definitely choose the acalabrutinib. It also bothers me to take three new drugs at the same time. If you are allergic to one of the three, how will you know which one you are allergic to? The real reason is the low percentage of serious adverse reactions and the high response rate for acalabrutinib. I am not a Dr or health professional, but I do have some common sense. Read the clinical trial preliminary results and decide for yourself. IF link below fails google "acalabrutinib" and select the one that starts with nejm (Article co-written by Dr Byrd). I am currently W&W and am mainly waiting until I can get access to acalabrutinib.

Best wishes & good luck

Jack

nejm.org/doi/full/10.1056/N...

[Cllcanada Top Poster CURE Hero]

I would lean to Quality of Life and put that finger on the scale...as butchers used to do apparently... to increase the weight and value of prime rib roasts...

Ultimately it is a decision about life... length AND quality.

~chris

[thompsonellen]

Sandi,

I know this is a hard choice and ultimately you need to go with your gut.

You know what I did - I am at OSU and I am flying out of BWI because it's so much cheaper than Phiily. And I not only work full time, but have a start up company. For me, the time commitment is a killer. I do have the savings to cover than travel and my co-pay is $10 for Ibrutinib so at least that was ok.

For me, it came down to my 16 year old. I felt I needed to do what gave me the best choice at longevity regardless of the upfront costs and risks. Dr. Byrd said I needed to go for 40, not 4 years, and felt this was the best plan. It this doesn't work, CAR T would be plan B.

But again, it's a very personal choice. I went with my gut. And time will tell if it was the right thing to do.

Let us know what you do.

[SandiC in reply to thompsonellen]

i hope to make a decision soon. I am holding the 25th of 25 slot for treatment naive. Wishing you everything you hope for and a great result. keep us posted.

[thompsonellen in reply to SandiC]

I heard they were very oversubscribed for treatment naive. I got some data back today which I will share. The numbers that deal with liver function are way up, because my body is dumping all these cancer cells but my WBC is at 32, down from 92 and lymphcytes down to 21 from 83 yesterday. That all from just 100 mg. They are infusing the rest today (900 mg). My only side effect today was 5-10 minutes of what I would cause pre-nausea. I still was able to do a work conference call through it. My lymph nodes in my face are noticeably down - my face actually looked more sweetheart than round today.

[SandiC in reply to thompsonellen]

Wow, impressive! I know what you mean about the face... I remember that app on my phone that made everyone's face look fat (FatFace?). I am discouraged when I look in the mirror but know that will get better with whatever treatment I decide. We are about to have our 4th grandbaby next week. We will be going to Portland, OR to help out July 4th. After return, will start one of the treatments.

Hope to make a decision soon but carefully.

[nvp815]

What an incredibly difficult decision you have to make. I think I would share all your same concerns regarding side effects, costs, and inconvenience. They are all good reasons to pursue the NIH trial. I believe keeping your life as uncomplicated and stress free as possible while undergoing treatment is an important consideration. So if the acalabrutinib study will cause less physical, emotional and financial stress then possibly that is the way to go. Either way, you are going to be receiving world class care and hopefully get a great response.

Wishing you much luck as you make this decision.

Nan

[johnl]

The only thing I have to add is that you can probably get your ibrutinib copays picked up by charity funded by the maker of Ibrutinib. Check this out if it would effect your decision.

john

[Mrsminton]

Please look into charitable organizations that provide help with transportation for patients - such as "Angel Flight" - to help with travel costs if you decide on that option.

[ladyprescott]

Hi Sandi....I too had higher than normal lymph count several years before I was diagnosed. I had done medical transcription, so knew a 'little' about red, white, and blue counts. "yes, I know there's no blue, but just threw that in". When I asked my doctor about the high count he dismissed it. I know in my heart that it was beginning then even with no elevated white count and all else normal. Since I'm on W&W, I cannot advise you one way or the other in your dilemma, but I want you to know I wish you the best outcome. This site is the greatest. I found it by accident and so happy I did. All on here are wonderful people facing the same problems. My best to you. Carole

[SandiC in reply to ladyprescott]

thank you so much Carole. I even had a lymph node biopsy in 2009 and ct scans that showed lymphadenopathy back then but didn't get diagnosed until last June when I had routine blood work at the same time that I was SUFFERING from 20 chigger bites all around my thighs and hoo ha . I thought the HIGH wbc was from the bites at first. From there, oncologist, tests, etc. and have been progressing much symptomatically in the past 6 months.

Actually glad that I didn't know back then. Best to you too

[ladyprescott in reply to SandiC]

You're welcome, Sandi. Just remember, all of us are in the same boat on this site. Always someone to talk to and with good info. Take care, girl. Carole

[fayeander]

Hi Sandi,

God Bless You! You do have a huge decision to make. I can't give advice on this one, it's something you have to do, but I will tell you that I will be praying for you.

I know how much those grandchildren mean to you, as I have two precious granddaughters who helped me through my chemo treatments six months ago. They were also what kept me sane during my husbands death, their Papa, and they continue to help me.

My prayers are with you during this time of decision making and afterwards during your treatments.

Faye

[Hidden]

A tough decision... I am on Acalabrutinib (ACP-196). I have been on it for a year and a half. The drug works quickly. After 12 months I was in partial remission. The lymph-nodes, fatigue and night sweats are all gone. I have had no negative side effects. I got my quality of life back - it was a life changer. Other test subjects on the same drug that I have spoken to had the same positive experience. However, Venetoclax may be the knock out punch - the elusive cure. Ibrutinib has side effects. The side effects could be a game stopper. If they were using Acalabrutinib instead of Ibrutinib, I would be more inclined for the OSU trial.

With Acalabrutinib you will acheive the quality of life with little inconvenience. It will buy you time. With the three drug combo, the outcome is unknown due to side effects and the travel will be a nuisance.

[SandiC]

Thank you so much for your input and so glad you are doing so well. Will let everyone know when I decide.

[Jill4]

No advice, just sending hugs, good energy and wishes for a successful turnout. In two weeks I will have to make a similar decision. May all of us one day be free of these difficult choices. Best of luck.

[SandiC in reply to Jill4]

Hugs are great. Best to you too

[sallylou]

I personally would go for a cure, not just remission. I'm in year 3 of w&w. Wishing you all the best.

[sumok]

i just want to reassure you that you are fortunate to have two good choices in the midst of an unfortunate disease. there's no way right now to tell if one would turn out better for you than the other! that's why you have trouble deciding - there's no clear "bad" choice with the information you have now, just pros and cons. good luck deciding, no regrets best wishes for an awesome response in either case!

[SandiC]

Thanks so much. I do feel fortunate to have good options!

[wroxham-gb]

Big decision Sandi, take your time. Both treatments sound good to me.

Best wishes.

Sue