After monitoring for 1 year, my doc has recommended that I participate in Trial #EA9161, a 19-month program using ibrutinib, obinutuzumab, & venetoclax. I am a 52-yr-old male with no experience in this arena and am seeking all the advice/info I can get (especially first-hand, or very close to it). I have found many pros & cons to this Trial vs "standard care." I live a pretty active lifestyle & except for the lumps in my arm-pits & neck, hadn't noted any other symptoms. But lately, I have been more fatigued and have occasional night sweats. Will this Trial "take over my life?" (19 months is pretty daunting.) Will it quickly address the symptoms I have noted? Also, I am not ready to "go public" with this yet -- is it realistically possible to participate in the study privately, or is it pretty certain that all my hair will fall out quickly, I will be absent from work for long stretches, have worse fatigue, etc? Ultimately, my health is of greatest importance of course -- is there better Trials? Is the "standard care" of ibrutinib only preferable, or is there something better than standard care or what the Trials offer?
I am still finding my way around here, so I apologize if any of this is redundant etc. I really appreciate any advice/reviews/etc y'all can provide or direct me to -- I want to make the best decision. God bless.
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CLL is a complex and varied and individual disease. The treatment options are evolving fast. Most of the questions we ask - have been in this Forum at some point. It is worth search the forum posts and checking through the pinned posts for a lot of helpful advice.
When you are able and when you know do feel free to share your blood result numbers and CLL type.
As for going public - thats a very personal choice - and I am sure you will get replies. I went public - it was impossible to hide in a small rural village in the UK. I found the support I got was amazing and glad I did.
Thank you very much Jig! I will do a follow-up post with more detail — but I was just initially seeking impressions from folks for the issues mentioned, I didn’t want to overload everyone with TMI (haha)... Anyways, thanks again — take care & God bless.
There are several questions in your post. First up is around when is it right to treat. Doctors advice watch and wait until the disease is “active” some of the symptoms you mention are definitely in the official list of reasons to consider treatment from an international consensus statement which reads as follows
“Active disease should be clearly documented to initiator therapy. At least 1 of the following criteria should be met.
Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia. Cutoff levels of Hb <10 g/dL or platelet counts <100 × 109/L are generally regarded as indication for treatment. However, in some patients, platelet counts <100 × 109/L may remain stable over a long period; this situation does not automatically require therapeutic intervention.
Massive (ie, ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
Massive nodes (ie, ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
Progressive lymphocytosis with an increase of ≥50% over a 2-month period, or lymphocyte doubling time (LDT) <6 months. LDT can be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months; patients with initial blood lymphocyte counts <30 × 109/L may require a longer observation period to determine the LDT. Factors contributing to lymphocytosis other than CLL (eg, infections, steroid administration) should be excluded.
Autoimmune complications including anemia or thrombocytopenia poorly responsive to corticosteroids.
Symptomatic or functional extranodal involvement (eg, skin, kidney, lung, spine).
Disease-related symptoms as defined by any of the following:
Unintentional weight loss ≥10% within the previous 6 months.
Significant fatigue (ie, ECOG performance scale 2 or worse; cannot work or unable to perform usual activities).
Fevers ≥100.5°F or 38.0°C for 2 or more weeks without evidence of infection.
Night sweats for ≥1 month without evidence of infection.
Hypogammaglobinemia, or monoclonal or oligoclonal paraproteinemia does not by itself constitute a basis for initiating therapy. However, it is recommended to assess the change in these protein abnormalities, if patients are treated. Also, patients with CLL may present with a markedly elevated leukocyte count; however, leukostasis rarely occurs in patients with CLL. Therefore, the absolute lymphocyte count should not be used as the sole indicator for treatment.”
Having been recommended a trial I’m sure your doctor must think you meet the criteria since trials are quite strict about who they let in. But you can talk to your doctor about what would happen if you do nothing and what alternatives are available.
As to what treatment to go for, the study you have been offered combines several medicines all of which have licenses and are known to work either alone or in other combinations or both.
Historically the standard treatment for CLL was FCR chemotherapy and in some patients and some counties it remains the first line choice. At 52 you’d be considered young and if fit and meeting certain criteria you’d be perhaps considered for it. It is chemotherapy However and as such people do often have to have time off tho typically don’t loose hair with that or any other treatment.
FCR evolved as the standard treatment following studies that showed it worked better than the individual drugs alone fludarabine cyclophosphamide and rituximab.
The study youd been offered is essentially trying to recreate a new FCR. Combination treatment alllws you to target the cells by three different methods in a time limited way. 2 years sounds long time until you realise that Ibrutinib if taken alone has to be taken indefinitely (until it stops working or you get side effects you can’t tolerate).
With FCR treatment many people get to the point where their disease is undetectable and if so can have really long remissions where they need no more treatment (in some cases these last over twenty years and some doctors think this might represent a cure). With some combinations of modern treatments (including the great data we have on V and O togeher which are two of the drugs in your study) we know that an even higher proportion of people get to that undetectable status and so the hope is that some of them may actually be cured. Even if that is not the case the hope is that by combining treatments like this if the disease does grow back it will not grow back resistant (since any clone that is resistant to one of the treatments would have been killed by the others)
These drugs in this study are usually better tolerated than chemo tho they are not without side effects. Your doctor will share a list but you should remember that not everyone will get al those side effects. In fact some people get no side effects at all. Treatment should quickly address your lumps and for many people is associates with an improvement in fatigue too. And none of this is a guarantee of course.
Trials are often a great way to get the latest combinations before they are otherwise available and without charge also. Care is often very good in trials too. And we feel we are contibuting to the knowledge that will help doctors know what to do in the future both for other patients but also for ourselves if we relapse again.
The trial you mention is one of two that many on here are excited about and want to get into. The second is similar but replaces Ibrutinib for a newer version of it called acalabrutinib. Many feel that some combination of drugs that includes venetoclax is the way forward.
If you didn’t want to do a clinical trial your main options would be if you are in the USA and have funding)
FCR (depending on your markers)
VO (using two of the drugs in the trial) recently this was approved in the USA and it is at the last hurdle of approval in Europe for firstline therapy.
Ibrutinib or acalabrutinib in monotheapy ongoing.
You hopefully can continue to be private about your health no matter which treatment you choose tho if lumps are growing people might start to notice that if you decided not to choose. I do hope you have some friends and family you are open with and some people you can discuss this decision with.
Thank you very much for taking the time to provide me with such a detailed response, Adrian! I am really moved by how much support is given here — so wonderful! I believe we can never have too much info — and although the stats/etc provided by docs are informative, first-hand experiences really round out the whole picture. Thanks again — take care & God bless.
I love the trial your doctor has suggested for you. It contains, in my lay view, the three rock star drugs of all the exciting new drugs. This is not a super experimental last chance clinical trial. These are three proven drugs that work great individually and there already is abundant evidence to suggest they have great synergistic effect when used in combination therapy.
I do not think you will miss a beat at work or at play with this combination, other than the days for obinutuzimab infusions. You might have some infusion reaction with the first infusion, but you can work through that. Maybe take the first or first and second week off of work just to adjust to new meds.
You are not having chemo, you shouldn’t lose hair. While these drugs can have side effects, for most of us the side effects are mild and tolerable.
I think there is a high probability you get a long and sustained remission from this trial. I don’t think a cure is out of the picture for some on this trial.
I think it perfectly possible to keep your trial and your Cll confidential. That’s a personal decision. I told a few people who needed to know. I suspect most all my friends know now, I’m in a small town. And as time went on, I cared less who knew and who did not know anyway.
Good luck. You will do great on this trial. I wouldn’t give it a second thought joining that trial.
Thank you so much Jeff! The doctors stats are 1 thing, but to hear such positive news from someone with no “agenda” is very reassuring. I really appreciate all your time & help! Take care & God bless!
This trial you are talking about is pretty much the Holy Trinity of drug combos for treating CLL. The only thing that would make it holier would be acalabrutinib in place of ibrutinib. But really, I+O+V=dynamite treatment for CLL. Many of us would love to have access to that combo.
It's always hard to predict how any individual will react in terms of side effects. But its quite possible you could get through this without needing to disclose. Hair loss is not expected. I've heard a few people mention being tired and needing some recovery time after each Gazyva infusion (6 cycles). So you may want to plan a day off work following each infusion.
There will be a certain amount of trips to labs and medical centres (ongoing) for testing and infusing and ramping up. So you may find it useful to tell someone at work that you will need to periodically take a day here and there. Or maybe your workplace is such that you can just adjust your schedule as needed without involving anyone else.
I was on ibrutinib 2.5 years and did great on it but developed afib. So am being switched right now to venetoclax, and rituximab (precursor to obinutuzumab) will be added next month. So far so good on the venetoclax.
This whole generation of the new non-chemo drugs (the so-called novel agents) is a completely different ball-game for cancer treatment. And it is in many cases possible to carry on a pretty normal life during treatment with some minor adjustments.
If I were given the choice between monotherapy with a 'forever' drug like ibrutinib vs time-limited therapy with the Holy Grail triple combo that would likely give me a long drug-free remission... I would not hesitate to choose the second.
Thank you so much for sharing this info Kim! It really means a lot — doctors’ stats are 1 thing, but first-hand accounts from folks without an “agenda” really carry a lot of weight with me. I wish you all the best with your treatment — take care & God bless!
Hi Like you, I did not want to go public about my illness and treatment. Since September I have been on the Flair trial (Ibrutnib and Venetoclax option). With the Venetoclax, I had overnight weekly stays in hospital (two nights on a couple of occasions) as they ramped up the dose. This was when it became more difficult to keep it quiet. However I have continued to work hard (even in hospital!) and play hard. No hair loss, some fairly horrible side effects many of which have either improved or I have found ways of dealing with them. So it is possible for the outside world to be unaware as a good positive outlook and need to be busy all the time can mask a great deal. I am actually constantly being told how well I look which can be incredibly annoying when I am feeling really lousy but of course is a good thing. A healthy active lifestyle (I generally spend a few hours each day out of doors) has been the answer for me and needing to go out (for pleasure and work) has meant that the mornings when I might otherwise have buried myself in bed feeling dreadful have not been able to happen and I have been much better as a result. Regarding the drugs, I was disappointed not to be randomised to get Ibrutinib on its own as I felt the Venetoclax was overkill for me. However, now I know a bit more, I feel that it is best to hit with all that is offered to you as the worst thing would be to go through years of treatment and end up with it not doing the job. Good luck!
Hi Dude, One thing that I have had to keep in mind with CLL is one thing at a time. I do tend to get 'out there' thinking way ahead of myself and then I get overwhelmed. I will tell you it is rather fascinating that I was with one Dr. and he put me on Ibrutinib for a year after 10 years of wait and watch. I then went back to my old Dr. here in town. He then put me on (it was my choice) Obintuzumab infusions and then Venetoclax pills.
This was BEFORE anyone had thought of this particular combo...I think I lucked out. I have had 4 infusions and am now at the max dose of 400mg of venetoclax. Your hair will not fall out - that has been documented. This is not 'regular' chemo. There are SO many types of chemo I had no idea until the CLL educated me. Everyone acts/responds differently. As you can read on this forum, many people are doing the treatment I am and simply carry on with their lives - period. I am 60 and am pretty sensitive to drugs so I've had some crummy days. Fatigue, no appetite, etc.....
Your questions are all good, this is a fantastic support group here. No one but my family knows what I am going through for the most part I chose to keep it private. I will say since going up to the max dose of Venetoclax AND an infusion last Monday, that had me feeling pretty awful but again, we are all different.
As my husband likes to say, you can do 19 months standing on your head! Not to downplay whats happening but if that 19 months can give you years possibly of remission.....a fair trade off indeed. I am so glad I did NOT go with FCR which was a possibility.....now that is a game changer from what I hear, even my Dr. says it is brutal.
So much hope on the horizon of CLL treatment! I am wishing you the best, hang in there and come back to this forum for help and support. The people here from all over the world are the best and have helped me so much especially when I feel like I'm in this alone - we are not.
Venetaclax didn't work for me. Brought my numbers down. But never got beter, it was very toxic to me, however i also have 17p deletion and no meds have worked for me. I have researched venetaclax and it works amazingly so your odds are great. Good luck
With regard to, "Will this Trial "take over my life?"
I entered a clinical trial in which I have to travel and even acquired temporary residence. I treated it with the same consideration as if I would have in the case it were a work related venue. I actually enjoyed the experience of adventuring a new community. I made some great friends that included those affiliated with the trial or enrolled in it.
I spent a great deal of time exploring and recreating in the trial area, learning about the local history and cultural activities, I tried out places to dine with new acquaintances, I attended sports events and church fellowship. I even crossed paths with people that I hadn't seen for many years from places distant and unrelated.
I understand that some have health issues or other life circumstances that provide more challenges. However, I believe that whatever we choose to do with regard to living with CLL, we can influence the outcome.
I encourage you to do whatever you can to improve your life and not allow CLL to take it over.
I just started the 5th cycle (each cycle is 28 days)of ea9161 and my numbers are doing phenomenal. I have had bouts of neutropenia (I’m slightly neutropenic now). I have not missed work except for infusion days. My hair was thinning before treatment but seems to have way slowed down now. You can read my comments if you click on my user name. Good-luck! Lisa
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