Update on ibrutinib treatment

[New1948]

Had my end of cycle 6 ibrutinib monotherapy appointment this week at MAYO Florida. MRD test shows CLL present at 0.27%, down from 0.50% 3 months ago. Ibrutinib is doing it's job - all blood counts are normal. Hope others on ibrutinib are doing as well.

[PlanetaryKim]

Congrats! Was your MRD test done on blood or bone marrow? Is it a FLOW cytometry test that gives that information? I would be interested in finding out where I stand after 19 months of ibrutinib monotherapy.

kim

[New1948 in reply to PlanetaryKim]

Yes, it is a flow cytometry test of the blood. If on two consecutive MRD tests of blood (done at intervals of 3 cycles-12 weeks) are determined to be MRD negative, a bone marrow biopsy would be done to see if the bone marrow is MRD negative as well.

[cajunjeff]

Thanks for sharing your good news. I was not aware of this trial. I assume when you write about cycles that a cycle is four weeks and that you are now at 24 weeks on ibrutinib, right?

So the purpose of the trial is to see how many people get mrd negative on ibrutunib mono-therapy? That's interesting. I thought this was something they pretty much knew, that only a small percentage of people taking ibrutinib by itself get complete remissions. Have they told you any preliminary results of the trial?

I am on ibrutinib mono-therapy and have been operating under the assumption ibrutinib is unlikely, by itself, to get me to mrd negative status. That's why my doctor is considering adding venetoclax, which in combination with ibrutinib is getting lots of complete remissions.

I would be very curious to learn what my chances are of getting mrd negative on ibrutinib alone. My understanding right now is that while they are seeing some people get mrd negative, its a relatively small percentage.

[Hidden in reply to cajunjeff]

read new1948 history, Had 3 months of gazyva first then went on the Merit trial(her words not mine) of one ibrutinib 420 mg daily

[cajunjeff in reply to Hidden]

I don’t understand your point in relation to my questions. The MERIT trial is an ibrutinib monotherapy trial. The three months on Gazyva has nothing to do with the trial so far as I understand the trial.

My questions deal with what expectations there were that ibrutinib monotherapy gets mrd negativity. I don’t think Gazyva is part of the trial protocol. I was aware new1948 had used Gazyva, but I don’t see what that has to do with my post.

clinicaltrials.gov/ct2/show...

[Hidden in reply to cajunjeff]

i guess i misunderstood your question. I was thinking would the ibrutinib worked as well i f gazyva had not been used. just wondering

[cajunjeff in reply to Hidden]

I think if the trial designer thought Gazyva would have been a big help getting to mrd negative status, having used it before would be an exclusion criteria for the trial.

The current thinking is that adding a monoclonal antibody to ibrutinib, like Rituxan or Gazyva, doesn’t add much, it just might knock wbc down faster. In the trial comparing ibrutinib to ibrutinib plus Rituxan, both arms did about the same, leading to the conclusion ibrutinib was doing most of the heavy lifting.

I am curious how the merit trial is going because I thought they already knew that a relatively small % get complete remissions on ibrutinib alone. I am on ibrutinib and am sure hoping to be in the group that gets a remission. But I might not be waiting long enough to know if my doc adds venetoclax in the summer. We pretty much know for sure adding venetoclax to ibrutinib very much increases the chances of remission.

[Murzik in reply to cajunjeff]

Just a little correction. We DO NOT KNOW if Gazyva adds better results to ibrutinib. Trials are going on.

But you are absolutely correct stating that Rituximab does not.

Be well, G.

[cajunjeff in reply to Murzik]

Murzik, words do matter, and I didn’t write we “know” what Gazyva does when used in combination with ibrutinib, rather I wrote what the “current thinking” is.

Gazyva and Rituxan are not only both monoclonal antibodies, they are both cd20 monoclonal antibodies and therefore have a very similar mechanism of action. Gazyva is thought to be a stronger version, so it’s possible it might have more synergistic effect than Rituxan, but it’s not thought to make that much difference in the long run because it works in a similar way to Rituxan. There are other monoclonal antibodies that have other targets than cd 20.

We are seeing combos like Ibrutinib, venetoclax and Gazyva, but even if that outperforms Ibrutinib plus venetoclax, that wouldn’t necessarily prove Gazyva has meaningful synergistic effect with ibrutinib, it could be having the synergistic effect with the venetoclax.

In any event, my post was not meant to rule out Gazyva adding to ibrutinib, I specifically made reference just to the ibrutinib/Rituxan trial. But when I asked my doc about adding Gazyva to my ibrutinib, he told me he didn’t think adding a cd20 monoclonal antibody would add much. He did say it would make my wbc go down faster, but he wasn’t concerned about how fast ibrutinib brought down my wbc, he said slow and steady was fine.

[New1948 in reply to cajunjeff]

MERIT trial requires one other treatment without remission, and a waiting period of 56 days. The ibrutinib cycle is 28 days. I'm told there are 24 participants in the trial, but do not know any results of the others. My blood MRD just before starting ibrutinib was 0.38%, after 3 months was 0.50%, and at 6 months was 0.27%. I spoke with my specialist about adding venetoclax and was told he'd rather hold back to see how mono-ibrutinib does. So far ibrutinib seems to be keeping my counts in normal range, with no side effects.

[Kokobean]

This is such great news! Thanks for letting us know.

[zaax]

I'm on Ibrutinib. What do you mean by 6 cycles?

[J_88]

What deletions do you have new1948?

[New1948 in reply to J_88]

Trisomy 12

Unmutated

Notch 1

B2M

Might be a couple of others

Also have MS, dx in 1980, and has been stable since last exacerbation some time in mid to late 1980s. Only minimal residual effects (double vision, some weakness on right side).

[bkoffman CLL CURE Hero]

U-MRD is exceedingly rare with Ibrutinib on its own, but very durable remissions can be had without and your results bode well. Stay strong. We are all in this together. Brian

[Brassy]

Congratulations New1948. Wishing you continued success. I have participated in the Merit Study for the past 13 months. This study is for CLL patients who have been previously treated for CLL and have not achieved remission. It seems a number of us receive 3-4 rounds of Gazyva and then 60 days later can participate in the Merit Study. I began with .01% MRD and am now .05% at 1 Year of Ibrutinib monotherapy. The study is for 3 years. Blood MRD status is tested every 3 months. If a participant receives MRD negative status for 2 consecutive blood draws, then MRD in the bone marrow is tested. Study participants’ Ibrutinib is free, we are responsible for visits, tests, etc.

[New1948 in reply to Brassy]

Accurate description of the MERIT trial. My blood MRD just before starting ibrutinib was 0.38%, at 3 months was 0.50%, and at 6 months was 0.27%. Still a ways to go to get below 0.01%. But, I'm doing ok. Adderall helpful with fatigue/energy. At least I am now on a MAYO visit cycle of 3 months with blood draws in Wilmington on the other 2 months. Besides you and me, I'm told there are 22 other participants. Victoria, the ARN, is my favorite member of the MAYO team.

Hope this disease can be conquered.

[Brassy in reply to New1948]

Victoria is the best!

[agatha123]

Super!!!!!