Ibrutinib / Venetoclax

Hi my fellow CLLr's

I need some feed back. I just had my 3 month visit to see my Oncologist at M.D. ANDERSON and I'm very confused on what I should do. Even though my doctor says my numbers look ok and I don't have any symptoms other than small swollen lymph nodes and occasional night sweats he offered me a trial drug Ibrutinib/Venetoclax starting in June. I thought if my numbers were ok and my symptoms weren't that bad that I would be on watch & wait longer. I need some advise...should I jump into this trial or continue watch & wait?

Here are my numbers: Hgb = 41.6 Platelet= 122 RBC= 4.89 White Blood Cell = 75.9

Man Lymph Abs= 66.03 Man Neut Abs = 5.31

I'm not sure if I should start treatment.

I'm 13q Unmutated.

Regards,

BC

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76 Replies

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  • Jump on the trial if it were me. Your starting to experience B symptoms and your doctor is suggesting this excellent trial.

    If you're really unsure, get a second opinion from someone who is a CLL expert, which is not here. 😃

    Being unmutated, this trial screams your name in my opinion

    Jeff

    Edit:

    You're going to MDA. You couldn't get better advice.

  • Thank you for your response. I will be considering doing the trial...i just wasn't sure if the pros out way the cons...such as side effects.

    Best Wishes

  • My husband is in that trial. He is doing well now, but experienced a-flutter due to the ibrutinib. After getting that straightened out and starting on the Venetoclax he is doing well. He will ramp up to 400mg this week. No side effects and he is feeling good. His platlets have doubled and his henaglobin is near normal. I think it's an excellent trial with the possibility of a cure. He is 13q mutated.

  • I agree with justasheet1. Starting to experience B symptoms, you are at a top notch facility with CLL experts and are being offered maybe the most promising treatment combo yet. Get a second opinion if it will help ease your mind, but this is like the quote from the Godfather movie..."an offer you can't refuse". :)

  • Haha...thats one way to look at it. Thank you 😎

  • Thanks BC-I'm getting ready to make the same decision. I guess we're fortunate to have a choice but I'd like it to be one that I'm totally on board with.

    Best of luck and guidance to you.

    bill

  • That's how I feel. I always thought it was better to hold off from taking treatment until you absolutely have to.

    Best Wishes...

  • My initial thoughts aligned with yours about holding off treatment as long as possible. But I've read your previous posts and you seem to have been experiencing some unpleasant B symptoms for nearly a year. With painful lymph nodes, spleen issues, sickness and feeling like I had the flu some days, I'd jump at the chance of this particular trial.

    Hope everything works out.

    Newdawn

  • The pain and sickness I was experiencing turned out to be IBS. This was determined after I recently had an Endoscopy and Colonoscopy done. Since I have been on a Gluten free diet I have been doing much better. My symptoms from CLL are mild that's why I'm not sure if I would be starting treatment too early.

    I have until June to make a decision.

    Best regards,

    BC

  • After a year on chorambucil and prednisone I'm toward the end of a 6 month, symptom free holiday.

    Numbers are rising but no symptoms. Nevertheless my Cll expert, whom I trust, wants to start ibrutinb and venteclax as soon as my tests results are in. She said we should stay ahead of it. But, like you, I hate to interrupt a feel good streak. It will be revealed. Take care-bill

  • I totally understand.

    It's not an easy decision unless it's the only one at the moment.

  • I think it's important to be psychologically ready for treatment as well as physically BC and this seems to have come out of the blue for you. You have some months to make a decision so take some time to think about things.

    Your levels are not dramatically different from mine except for your lower platelet levels. In terms of standard treatment criterion, it would only be the constitutional symptom of 'night sweats for more than 1 month without evidence of infection' that would qualify from what you've described. However we don't have the full picture and your specialist is a leading expert at a centre of excellence. Sounds to me that he's offering you the chance of a very promising trial ahead of recognised treatment timing. Maybe being unmutated is a factor. (I don't know my genetic profile or mutational status).

    You don't have to take this trial and there could be similar opportunities further down the line. I seem to think you've been diagnosed under 2 years so it's not hard to understand your thinking.

    This has to be the right time for you and I wish you well in your decision. It is however an incredibly promising treatment combo that I'm not likely to be offered.

    Newdawn

  • You're right..im still trying to wrap my brain around this..i do see this could be my opportunity..im just not sure if there are any serious side effects regarding Venetoclax since its a fairly new drug. From what I have seen on Ibrutinib the side effects are minimal.

    I will let you know what I end up doing.

    Cheers!

  • With these new targeted drugs that are achieving good results, some CLL experts are beginning to question whether it would be better to begin treatment earlier rather than hold off. In the recent Patient Power conference in Houston, I can't remember if it was Michael Keating or Nicole Lamanna who mentioned this. Also being unmutated, if I were near MD Anderson, I would readily jump into this trial. Since Michael Keating is at MD Anderson, you have experts who are up on the latest.

    If you haven't watched the videos from the Houston conference, you can see them here:

    patientpower.info/event/cll...

    patientpower.info/video/und...

    Good luck with your decision and journey.

  • I think you may be right regarding watch & wait..this may soon be a thing of the past..no more watch & worry.

    BC

  • Whether to treat early I believe is still an open question. Is clonal evolution more or less likely with treatment? Are the side effects of treatment worse than pre treatment? Does our immunity to infection improve with treatment? Is it fair to say your first treatment is your best shot? I think if you feel poorly you should consider treatment. If you feel pretty good maybe wait for more data...more evolution of treatments

  • You see this is why I'm confused..all of these unanswered questions...and unless I can talk to someone that is already on this treatment I won't know what the side effects are regarding Venetoclax.

    Best wishes

    BC

  • I have been on Venetoclax (no ibrutinib) since 12/14/16 with absolutely no side effects. This is my first treatment for CLL. Tumor lysis syndrome when starting Venetoclax treatment is one of the biggest concerns, but they watch you very closely during the 5 week dosage ramp up from 20 mg daily to 400 mg daily to avoid this. If you are at high risk for TLS they put you in the hospital for initial doses to watch you very closely. I was only at moderate risk for TLS so I was managed outpatient with close lab monitoring and good oral hydration. My labs are now completely normal and my fatigue and fogginess have lifted. I really didn't realize just how tired I was and how much this disease had taken from my quality of life. It's been a miracle for me.

  • That's good to hear. I was hoping someone currently taking Venetoclax would reply. I'm glad it's working for you. It does give me hope I will have the same results. Please keep in touch.

  • I will keep everyone posted here. I just got another set of labs back this afternoon. Everything still completely normal.

  • Excellent!

  • You are so blessed! I hope this continues for you. It is always good to hear the good news vs. all the bad stuff! Thanks!

  • Understood. Im in the same boat. My sense is the side effects are not too troublesome for most. They can always stop or slow down. My concern is do we build some kind of resistance to this drug and is it better to "save it" for later and start with something else. Ive struggled with this...there simply is no answer but at least we have much hope.

  • So much to think about. I'd get a second professional opinion!

    Edit: did you see this?

    onclive.com/onclive-tv/dr-b...

  • I agree

    Thank you

  • I just watched the video.

    Thank you

  • I was in a similar situation to you a few months ago. I'm "normal" FISH, unmutated and ALC was around 100K (no major B symptoms) when the treatment talk came up. I was 2 years from diagnosis.

    Rightly or wrongly, I opted for the I+ V trial and have been on I for 6 weeks. Mr Dr said treatment would be needed in the next 12 months and this was a particularly good option as I'm unmutated. I decided it's best to start now while I'm fit (51yo and otherwise in good shape) and there's a good option available. I think waiting as long as possible is important if considering chemo but I'm not so sure with targeted therapies. My opinion was to try and kill the CLL off now to reduce the chance of richters and other problems popping up. The trial is based on good science with 2 very good drugs. If it keeps me going for 10 years, there'll probably be a cure available if this isn't it for me.

    I'll tell you in a few years if my decision was right. You've just got to make a call and not look back.

    PS - the level of care I've had on the trial so far has been excellent - far better than I would have received as a standard patient. The only downside is there's more CT scans than I'd like.

    Good luck!

    Graham

  • Good luck Graham and thank you for doing the trial.! I read somewhere that the fear of CT scans is way overblown as that is of concern to me as well. May I ask if your platelets were normal before the trial? Did you have any fatigue or night sweats? Thks

  • Platelets were OK, HGB normal but a bit low, some fatigue but not enough to stop me doing what I want and some sporadic night sweats but nothing serious. ALC doubling around 9 months and a few nodes around 4-5cm. I was still in decent shape and could have waited longer, but treatment was inevitable.

    I'm unsure about the risk of CT scans for imunocompromised. The trial documentation said 1:500 chance of secondary cancers (maybe based on general population though) from the scans which is better than FCR.

    Graham

  • I wish you the best with your treatment. Hopefully it leads to a long remission or even a cure.

    BC

  • I wish you the best on your journey. I'm leaning more and more towards doing the trial. The unknown is what is eating at me.

    Good luck

    BC

  • I was told by my CLL specialist that I could opt for MRI's instead of CTs. However whatever imaging modality you begin the trial with is what you have to continue throughout the trial. This may not hold true for all clinical trials at all centers, but it is worth asking about. I ended up not going onto a trial, but had MRI's rather than CTs prior to beginning treatment. We really don't have data about the risk of CTs for an immunocompromised person.

  • You are correct. I am doing MRI on my trial. CT and cheaper and quieter- but a lot of radiation!

  • My trial allowed for MRIs only if allergic to the CT contrast. Otherwise I would definitely have gone for MRIs. At the end of the day though, I'll accept the CT risk - it is a bit unknown but better than alternatives and trials have broader benefits.

    Graham

  • Closh I like "make the call and not look back". Great words for me today.

  • My CLL specialist wants me in the same trial. I too am 13 q, but am unmutated and have TP53 issues so we will be considering that as well. My thought process is still forming so I know where you are coming from. I have some swollen nodes, and occasional night sweats. Fatigue is crushing at times. Numbers are increasing but not alarmingly fast. It seems that in the year since I was diagnosed watching and waiting has changed to watching and waiting for a trial! I guess this is a good thing but don't know for sure. Good luck with your thought process. Let me know what you decide, if we both go for it we can compare experiences.

    BeckyL

  • Sounds good..if you follow me I will keep you updated. Let me know if you decide to take the plunge and we can compare thoughts. I will follow you.

    Best Wishes

    BC

  • Okay, am now following you! Here's to both of us!!

  • Cheers!

  • Unmutated and TP53 means Ibrutinib or trial IMHO. Your choice and whatever you decide, do it well and don't look back - we've got good options!

    Graham

  • I was in about the same situation and didn't want to get onto a trial. Then my neck lymph node started to swell and get painful my groin as well. So I jumped on the trail at UCSD. The same one that you are on I've been on for two months and doing well so far .

    I know how you feel though If you don't feel too bad right now it is hard jumping on a treatment

    June is still 3 months away. I would sign up for it and see how you feel at that time. It is hard to pass up though since it's all drugs and no intervenous or chemo therapy. The hope of this trial is it is such a good combination that you will be able to get off all medication at a certain point.

    Of course avoid any trials involving chemotherapy given that you are on mutated.

    I am 17 P delete it so this trial is very important for me.

    I feel a lot better now. It would've been good to get on my trial a little earlier but I had to wait till it open.

    Hoffy.

  • Hi Hoffy,

    If you dont mind me asking do you have any side effects? I hear some say..Rash..joint pain..sick feeling?

    -BC

  • I know these are both oral drugs, but how long did you have to be st the treatment center before you could go home? How often did you have to go back, etc? My site is 2 hours away, but my son lives there so I can camp out at his house if I need to.

    BeckyL

  • My doctor says I would need to be in the hospital for the first 2 days to watch for any problems then I could go home. I only live an hour from M.D. Anderson so it's not too bad to travel back and forth.

    -BC

  • This varies a lot between cycles and what tests are done. My usual Ibrutinib cycle visits are a blood test the day before a 15 minute appointment and pick up another bottle of pills. You can probably do the day before (safety) blood test locally. On appointment days I sometimes have another blood test for the trial.

    Other appointments may require a full day if there's CT scans, bone marrow biosy or blood tests over several hours.

    The Venetoclax ramp ups (month 4) require visits over 2 consecutive days for the first 2 weeks then weekly visits for the next 3 weeks.

    After 15 months, you go onto 3 monthly visits.

    Most of the time it's just taking a few pills at home. Pretty easy really.

    Graham

  • Sounds like you are doing well on this trial...Can I ask if you are having any side effects from either one? Such as fatigue..im wondering if I will be able to work while on the treatment.

    Regards,

    BC

  • I'm only on the Ibrutinib at the moment and will start adding the Venetoclax in 6 weeks time. I feel a bit tired but this is similar to before I started treatment. It seems to be slowly getting better. I'm able to work, go to gym, ride a bike ski etc so it's no big deal - probably 10% down on energy.

    I can't say I've had any negative effects so far except the dressing for a bone marrow biopsy gave me an itchy rash for a week. Damn that Elastoplast - I'll bring my own next time!

  • Good to hear! Thanks for the feedback.

  • So far I've been very lucky. A bit of joint pain and some fatigue but that is about it. The joint pain has gone away exercise I think helps. I am 53 years old and try to work out at least a few times a week. Some stomach issues for a couple weeks but that went away. The only remaining current issue is some tiredness and fatigue. But I had that before as well. I am told ACP 196 has less side effects.

    The big advantage of waiting is that when you eventually have more problems with your CLL and get treatment and you appreciate your treatment more.

    I almost started a grazyva imbruvica study last August but was feeling OK and because I'm 17 P deleted I decided to wait.

    But by December my nodes in the neck we're getting very large and people were asking a lot of questions and they hurt.

    I had a dental procedure and some cellulitis under my arm from a dog scratch and that I think aggravated the situation my white blood cell count went up to 90.

    I would see how you feeling June.

    Hoffy

  • I'm glad you are doing well.

    I will see how I feel in June and then make my decision.

    I will keep you posted.

    Good luck and I hope this new trial turns into a cure.

  • Sounds good, Keep me posted !

  • Oh yes! Definitely. I am so thankful for all that went before me in trials to get us where we are today. They will watch you like a hawk and work on your disease.

  • Thank God for the brave individuals before us.

  • Quite a decision. I'm not equipped to offer an opinion but can appreciate your dilemma. To be offered the trial is enviable to many I'm sure but....should you wait and see.

    Good luck with your decision.

    Peggy

  • Thank you..it is a big decision.

    Best Wishes,

    BC

  • Have you really researched all the possible side effects of ibrutinib/venetoclax? Do you want to be on a daily pill for the rest of your life? I too travelled to MDA to look at this trial. I am relapsed/refractory. It is a hard decision to make. What are your options if this does not work for you? It also is my understanding based on a previous post that only the Venetoclax will be paid for in the trial. I think you might want to discuss this with your insurance company. Not trying to be negative. Just giving you some food for thought. Good luck to you.

  • The V+I is aiming not to be a pill for life but you never know. I had those thoughts too until an old dude on another site said he had to eat every day, drink every day, breath every day, toilet every day and breathe every day - a pill every day isn't a big deal extra. I'd do it.

    Graham

  • Amen to Graham! You have to weigh risks vs. benefits with this disease(and all others)

    If diagnosed with heart issues, you take meds and smile that you have options

    I'm not someone who has ever readily taken meds not even Advil/Tylenol/Tums. Probably taken 20 in my entire 51 years so the thought of taking Imbruvica everyday jolted me.

    But I had to do something, so like you I looked at all options and went with best. I too have decided not to look back. If my treatment doesn't work I will reevaluate and move on.

  • I'm still learning about both drugs and the side effects. I'm also trying to talk to as many people that are currently on this trial as possible. I would only be on the trial for 2 years. I'm still not sure what I'm going to do. I have until June to decide. But so far the people I have talk to that are on the trial say good things about it.

    Best Wishes,

  • If one needs treatment I think this is the best option right now. Chemo may have short term treatments but has long-term implications.

    If you are mutated and do not have bad prognostic factors then it may last a long time. But secondary cancers is always an issue from the harshness done to the bone arrow.

    I know it's not a fair comparison but people who are treatment naïve respond better to IBruvica then people who are refractory.

    See the PowerPoint in the recent Ohio State webcast by Dr. Awan. (Sp?) about CLL

  • That's the big question...is treatment at this point in time absolutely necessary. I am Unmutated with 13q. My numbers are ok and my symptoms are not severe at this time. I was offered to start a trial in June with Ibrutinib and Venetoclax. So I'm trying to make a decision by June. I'm looking at pros vs cons on starting treatment early.

    Best Wishes,

    BC

  • Stay on watch &I wait if symptoms do not impact your quality of life or threaten your health.

  • i was diagnosed 26yrs. ago, and have always stayed off the meds as longggg as I can.

  • Hi, BC First, let me wish you well.

    I am 79 yo and also have CLL , going on 3 years. Mi WBC has been on the 20 to 26.000 range so my hematologist has kept me on W&W despite clinical trials availability for ibrutinib and venetoclax. According to CLL literature from various sources W&W is the recommended norm as long as no major symptomatic conditions arise and WBC count is under 100,000.

    MD Anderson is an excellent hospital so your doctor has probably seen something in your condition and perhaps early treatment is indicated. I havent read any of your other 62 replys, so maybe you will get other inputs. Good luck to you David

  • Thank you for your reply. Since my doctor hasn't said he thinks I need.. to start treatment I'm going to see how I feel in June and how my numbers look. I have a good Oncologist at M.D. Anderson and I know they want the best for me but I will have to be convinced that I need treatment before I jump in head first. I agree with you watch and wait is best unless my symptoms or my numbers start to get worse.

    I wish you the best.

    BC

  • I opted for Ibrutinib/Venetoclax trial and am currently in the Ibrutinib only stage. Started discussing with consultant in December after his view in September was "I think you'll need treatment within 12 months". Final decision made in Jan - but I think I knew I didnt want Chemo again.

    Best, rob

  • I agree. How are you doing on Ibrutinib?

    This would be my first line of treatment if I start in June.

    BC

  • Ibrutinib seems to be fine, just completed third week. Have aching hand as of yesterday, could be muscle/joint pain some experience. But then again just might be a bit of strain. Will give it a couple of days to see if it clears - seeing consultant Friday anyway. It might just be co-incidental.

    rob

  • sounds like you are doing well overall.

    I wish you the best and please feel free to post your experience. This is a new trial and possibly a game changer for CLL.

  • Good afternoon! My doc is thru Abraham Cancer Center at Penn & I too was recently told about the trial. Prior to that I was trying to choose between BR & FCR. Am Over The Moon about it - time will tell ....

  • It's a hard decision. I'm going to see what my numbers look like and how I'm feeling at my next visit to my Oncologist at M.D..

    I Wish you the best on your decision.

  • BC, May I ask who you're seeing at MDA? I am a patient there as well. Currently on ibrutinib as a frontline.

    Kim

  • Hi Kim,

    I'm seeing Dr. Thompson. How are you doing on Ibrutinib? Any problems with it? I may be starting Ibrutinib in June.

    BC

  • I haven't met Dr. Thompson, but I did find some docs seemed to recommend trials more than others. After Dr. O'Brien left, I tried two other docs before deciding to see Dr. Weirda. He recommended treatment in August, but I wasn't feeling bad enough then to start. By the time late Sept. rolled around my symptoms had worsened. I probably should have taken his advice and started in Aug. I couldn't believe how fast ibrutinib worked. Nodes shrunk right away and my WBC has steadily gone down. I started noticing side effects after about 4 months. Mostly muscle weakness, aches and pains, hoarseness. For me it is very dehydrating, dry skin, dry mouth, even when I take in 90oz of water. So, I really have to stay on top of that or I get cramps in my toes/feet. The results are amazing though, so I'm hoping some of the side effects subside with time as they have for others. My next visit is in May, so we'll see what the labs show then.

    Good luck with whatever you decide, and keep us posted.

    Kim

  • That's great news you are doing well. I will definitely keep you posted. Are you still able to work while your on Ibrutinib?

  • Fortunately I am able to work from home. There are days where I'm too exhausted to leave the house.

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