CLL Support Association
10,274 members15,947 posts

Venetoclax and ibrutinib trial

Hello,

I’m on month 19 of a 26 month trial taking Venetoclax & ibrutinib plus aciclovir, co-trimoxazole, lansoprazole & allopurinol to counteract side effects caused by the Venetoclax & ibrutinib. My last consultation shows no evidence of CLL anywhere. This is great news but I’m thinking why I should continue taking the medication for another 7/8 month if there is no evidence of CLL. Before I bring this question up at my next consultation I just thought I’d run it past anyone here that has any experience, comments or opinion that they could share.

45 Replies
oldestnewest

Hi Mick

Really good news it’s no longer showing! Have you had a bone marrow biopsy recently or are the results from a blood test?

I’m not sure but I think the point of continuing the therapies once you’ve potentially reached MRD is to ensure a longer deeper remission.

Stuart

5 likes
Reply

Hi Stuart

Yes both bone marrow and blood tests show no evidence of CLL.

Mick

1 like
Reply

Mick,

Were you frontline or relapsed?

Jeff

Reply

Hi Jeff

Relapsed had around 4 years remission before it came back following first treatment of FCR.

Mick

Reply

Mick,

As Stuart just mentioned, that’s good news for us too.

I’m coming up on 4 years front line with BR but sadly the party is over. I’m trying to figure my next move.

Congratulations!🎉🎉🎉🎉🎉🎉🎉🎉🎉🎉🎉🎉🎉🎉🎉🎉

3 likes
Reply

Thanks Stuart and good luck

Reply

Thanks Jeff and good luck 👍

Reply

Hi Mick

That’s really good news then.. Ive been keeping an eye on people who are been taking those as a combination as I’ve heard some really positive results.

Hopefully once you’ve finished you’ll have a very long lasting remission if not indefinite..

Good luck with the remainder of the trial I hope it continues to work well for you, keep us updated on your progress.

Stuart

3 likes
Reply

Hi great news. As someone has already said continuation with medications, I believe, is to strengthen your remission.

Ann

Reply

So the theory is that tho they can’t detect any cells with the current level of Sophistication of the tests there may well be a tiny number of cll cells still hiding that they can’t detect. By prolonging the treatment they hope to mop up those last few cells and —-possibly—- even get a cure. (Tho we can’t know that for sure at this point as nobody has had long enough follow up at this point). In the UK Flair trial if you get to the point you are at (MRD-ve) then they will treat you for the same amount of time it took to get there. So if it took two years to get to that point they’d continue for another two years for example. Hope that makes sense. We know from FCR data that people who get to MRD negative have a LONG remission. So here’s hoping you stay well for MANY YEARS!

5 likes
Reply

Yes I guess that makes sense. Thank you.

Reply

Fabulous news, Mick!! I'm on month 7 of an I/V trial however, it is only for 15 months.

1 like
Reply

The current testing only examines 10,000 cells. MRD negativity does not mean that you have no cancer cells remaining. The theory is that the cancers cells are still there—but at level that is not detectable. So the drugs are continuing to decrease the number of CLL cells that are still present. The theory is that the fewer the CLL cells remaining, the longer your remission will be. If I were in your shoes, I would finish the trial. We don’t know how long of a remission this combo will provide. But you are more likely to have a longer remission if you finish the study.

Congratulations for being MRD negative. Thank you for participating in the study. I will need treatment within the next few years, and I hope I can get the combination of medications you are when that times comes. Let us know what the doctor says. I would love to know.

7 likes
Reply

Thank you I will post an update in October.

2 likes
Reply

Thank you for your explanation about the 10K cell testing. I still couldn't figure out why, if someone was MRD neg, they weren't considered "cured." (I'm aware that's not a word used with this disease, but with the amazing results of these new drugs, I haven't been able to understand why.)

Reply

If there are no cll cells left at all not just in the 10,000 sampled cells but nowhere in the body then perhaps it will turn out to be a cure. But we can only know that once someone has been followed up for day ten years or more and hasn’t relapsed. Sadly our disease has a habit of coming back. But if that’s in say 8 years time you can hopefully then piggyback from one treatment to the next. Here’s hoping your MRD negative does turn into a cure!

4 likes
Reply

Which trial are you on Mick? Sounds very like the trial I am on. 26 months for relapsed patients. Two months if I followed by 24 months of I+V.

On the trial I’m on I had three months of MRD -ve blood tests with a bmb on 3rd month that was also MRD -ve. Due to timings that spanned four months for me. Subsequently, as I had hit the target I+V have been stopped.

rob

rob

1 like
Reply

Hi Rob,

Are you still on the trial then or are you saying you finished it early?

Reply

I’m off V+I however still on the trial so still having all the checks as per the trial protocol at the appropriate dates.

2 likes
Reply

Ah ok thanks for that.

Reply

Mick,

I think it will depend on the trial you are on exactly what the approach will be, mine was controlled by BMB results, blood test results, ECG and CTscan results. Each trail could be different.

rob

Reply

Hi Mick

I'm on an I+V trial and after 15 months, went on to Ibrutinib or a placebo after getting to MRD- in blood and marrow. The trial aims to answer the question your posing - is there a benefit to continuing with this treatment after you get to MRD-? For us, if we start to relapse, the trial protocol adds back the treatment drugs so that's OK. I'm not sure what yours does but if I were you, I think I'd be happy to keep taking I+V for another 8 months just in case there's a few bad cells still hiding out somewhere.

Graham

7 likes
Reply

Yeah, but don't forget CLL is incurable. It will return if not held at bay.

1 like
Reply

Whilst that is correct sometimes it can be pushed back so far that for a normal lifespan the treatment is effectively a ‘cure’.

Furthermore, in some cases continuing a drug for a long time can result in the patient becoming refractory to it. Stopping potentially avoids that scenario and leaves some in the pot for later treatment. These are questions some of the trials are trying to gain an insight into.

rob

5 likes
Reply

CLL is incurable now, but one of the purposes of these trials is to see if there is a cure out there. Some of the people that have become MRD negative because of these drugs may indeed be “cured”. We just don’t know because there has not been enough time elapsed. My specialist, who is one of the trial physicians, is cautiously optimistic about the possibility of a cure.

BeckyL USA

6 likes
Reply

Hi BeckyLUSA,

Thank you for your reply and I must say, I'd never thought that there could ever be total cure but after listening to your response I'm invigorated because you're right. I just never thought it through. My life has been full of clouds that obscure things ever since being diagnosed with CLL in 2007. I've had many treatments including a "Stem Cell Transplant" all of which have had the CLL (with PT 53 dilation) return. I'm currently taking Venetoclax and its marvelous. My obvious hope is to see a cure and now, after hearing you, I've had a complete turn around with regards a real possibility of a cure.

Sincerely yours, Tony.

5 likes
Reply

Mind sharing which trial you’re on & at how many months did it take to hear MRD negative by blood or marrow? Great news Mick!!!

Reply

Thanks for sharing your information with the group. You are one of the pioneers that is leading the way to a cure in our lifetime.

1 like
Reply

I hadn’t really thought about it like that I guess my worries are a small price to pay if that were to be the end result 😀

4 likes
Reply

You signed on for the trial, unless you are having major side effects to give reason to discontinue you should stick it out!

1 like
Reply

That is a fair point too.

Reply

That is good news! I am in a similar situation and trying not to think past the moment which is the most real thing we have to focus on and creating better moments to experience.

Cheers Barger1951

1 like
Reply

Mick, what becky and others have said is quite important. also consider this--one of the goals of the various V & I clinical trials is to determine whether a cure theory is correct. The theory is that taking V & I for 5 years will "cure" CLL. The long duration of treatment is designed to permanently knock out the CLL beyond the remission stage you're in. As others have noted, MRD- is a test with limited accuracy. I was MRD- after a lot of chemo (I've been dealing with CLL/11q/unmutated/complex karyotype since 2005) and the CLL came back after 2.5 years.

so think of your current journey as half way to a cure. At the end of your five years on V & I you may be not only MRD- but also cured. In that context the pesky V and I side effects will seem insignificant, right?

4 likes
Reply

This gives me hope☺

2 likes
Reply

Yes absolutely 👍

Reply

I was diagnosed 5 years ago with CLL and have the trifecta: 17P, TP-53 & SF3B1. Fortunately I was part of MDA's early Ibrutinib/Rituxan study and was a happy camper for almost 4 years. Unfortunately, Ibutinib began to run out of gas and I moved over to Venetoclax which so far has done remarkably well. Long term, my hopes for many of us if not all is that we can live long enough to see CAR-T reach the success rate that has been realized with ALL and Lymphoma. I'm told by researchers that I've come to trust that we are hopefully within 2 years.

7 likes
Reply

Good to hear things going well for you long may it continue 👍

Reply

Thanks for your uplifting post!

1 like
Reply

Experts also seem uncertain, but there is discussion about having some in the trials who have no measurable disease stopping treatment to find out how many really are cured.

If your uric acid level is normal, the Allopurinol is likely now not necessary. I substituted cherry juice successfully after being on Allopurinol before Venetoclax and afterwards for a while.

Reply

Thank you to you guys on the front lines undergoing these treatments. I am one year into CLL and currently am watch and wait with an ALC of about 8500. Hopefully will not need treatment for a very long time. I can't help but think that what you are doing now will help so much in the future. Sleep well knowing that you are helping others.

3 likes
Reply

Mick,

I am on the Captivate I plu V trial. I am on month 19.

Got to MRD negative in the Bone marrow after 14 months.

I was randomized to Imbruvica or a placebo. I am 99 % sure I am on a placebo. All side effect went away, Fatigue , finger tips , stomach issues.

I have stay MRD negative in the blood so far. I have an appointment come up in a few weeks. Hopefully I stay MRD negative.

Over all I feel good but I have had a bit of fatigue lately. Hopefully it is just from doing a fair amount of recent travel.

I will keep everyone posted.

To answer your question- if you are MRD negative in the Bone Marrow it is worth asking about going off.

Dr. Kipps feels it does not makes sense to treat if you show no disease.

Be well,

Hoffy

2 likes
Reply

Hi Hoffy thanks for this 👍

Reply

I was on the I+V trial and on venetoclax for 10 months. 11q mutated 95% bone marrow infiltration, wbc of 50 at start of trial. I reached MRD neg in blood and marrow in February [Yay God!] and then was expected to be randomized to either placebo or ibrutinib. I decided to not continue on the trial for the following reasons: i was concerned about becoming refractory to venetoclax, I did not want to continue cat scans due to radiation accumulation, and I did not want to continue side affects of drugs. With the excellent results so far, by me and others, I figured that venetoclax would eventually be approved by FDA if I relapsed. In June it was approved for previously treated cll patients. The new I + V trial allows patients to stop drugs if MRD negative but they can stay on trial. My CBC still looks great. I don’t know if I made the right decision but hopefully with help of others on trial we will figure it out. Thanks to all for sharing!

2 likes
Reply

Hi yes these are my concerns too my side effects also include high blood pressure. For those that asked I’m on the Clarity trial as far as I know it was open to 50 patients and is now closed.

Reply

Hello to everyone that is following this thread. I promised an update.. and after discussing my question at my 3 monthly check up last week it was decided to continue with the medication. Thanks to everyone that commented and good health to you all.

1 like
Reply

You may also like...