New poster... Tirabrutinib study

[clljon]

Hello. I'm enrolled in a study at OHSU that is evaluating tirabrutinib (ONO/gs-4059) in combination with various other treatments. My arm of the study is for tirabrutinib as a single agent drug and I'm now completing week 4 taking a single 80mg tablet daily. So far, only very minor headache and lower back pain due to muscle tightness.

I was diagnosed in 2009 with deletion 13, high CD 38 and intermediate Zap70. Discovered early, I think, due to regular blood testing while in treatment for rheumatoid arthritis.

Treated with obinutuzumab in 2014-2015 with very good results, reaching CR and MRD negative. As a tremendous plus, my RA has also gone into remission!

Relapsed two years following end of the obinutuzumab treatments.

Have great hopes for tirabrutinib, which I've heard described as a version 2 of ibrutinib, both being BTK inhibitors. I'll try to keep you all apprised of my progress and experience with this treatment.

[nvp815]

Wishing you much success in your clinical trial. Thank you for your participation. I look forward to hearing about your progress.

Nan

[newyork8]

Best wishes. May I ask how your Obinutuzumab treatment went? Any side effects.

[clljon in reply to newyork8]

Except for moderate fatigue, no side effects. Treatments went very well, but are of long duration because blood tests come first, then wait for results before the pharmacy will begin to mix it up and then deliver it. Then a slow drip rate for caution's sake. Bring reading material!!

[newyork8 in reply to clljon]

No infusion reactions? Thanks

[clljon in reply to newyork8]

No, only mild temperature spikes during infusion monitoring that first day. Then they slowed the rate of IV drip until temps normalized again. That first day is only 10% of each of the following days volumes, but it was the longest in duration due to the very cautious drip rate. It was about an 11 hour day in the chair.

[clljon in reply to newyork8]

No, only mild temperature spikes during infusion monitoring that first day. Then they slowed the rate of IV drip until temps normalized again. That first day is only 10% of each of the following days volumes, but it was the longest in duration due to the very cautious drip rate. It was about an 11 hour day in the chair.

[newyork8 in reply to clljon]

Glad to hear! Im nervous about that.

[clljon in reply to newyork8]

No, only mild temperature spikes during infusion monitoring that first day. Then they slowed the rate of IV drip until temps normalized again. That first day is only 10% of each of the following days volumes, but it was the longest in duration due to the very cautious drip rate. It was about an 11 hour day in the chair.

[Justasheet1]

Please post often. I've read much on this very promising drug.

Jeff

[Hidden]

I would call it a second generation drug. The second generation drugs tend to be more targeted and therefore have fewer side effects.

[SunnyCA]

Please keep us posted and best wishes for your new trial

[jdshen]

Are you still on clinical trial with tirabrutinib at OHSU? Has the drug dosage been increased since your first cycle? Have you experienced any new side effects later on? Does the medication help improving your condition after months' trial? I have been offered for this trial during my yesterday office visit at due to lack of response from my previous lymphoma treatment.

[clljon in reply to jdshen]

Hello jdshen.

I continue on a single 80 mg tablet each day. I started on May 30, 2017 and have had just a few side effects, none of them troubling to me.

[jdshen in reply to clljon]

Thank you clljon for your quick response. I have went through the information that OHSU gave for review and I will sign the authorization form next week to accept the clinical trial of tirabrutinib as part of their phase 1 study. My problem is with WM, which rituximab does not work for me and I hope this drug will give me good response. Thanks again. If you live in Portland area, we may stay in touch and compare notes (my e-mail is [e-mail]). Thanks again.

John S.

[clljon in reply to jdshen]

More recent side effect was red rash-like patches appearing in various areas of my arms and hands from time to times. These resolved in a couple of days. No pain or itch or raised area just a visible area very near the surface of the skin.

In addition to the single 80 mg gs-4059 tablet each morning, I also take 800 mg of acyclovir each day to prevent recurrence of shingles and also an 800 mg/160 mg tablet of Bactrim twice a day for just two days each week to help prevent pneumonia or pneumocystis. I will need to take these supportive meds as long as I am on the trial drug.

The initial response in my blood work was a substantial INCREASE in WBC and ALC over 2 months, then leveling off and dropping slowly. WBC & ALC began at 46 & 39, peaked at 108 & 98 and is now 31 & 25. This increase and slow decrease was expected.

[andyroswilson]

Hi clljon - are you still on the same course of treatment and how is it going? I have been on identical medication since 2017)

[clljon in reply to andyroswilson]

Hello andyrowilson. I am still on tirabrutinib and I started in May 2017. It is working very well for me and I have had no real side effects. Just some minor bruising from time to time. I was pleased to learn that I will continue to receive the drug into 2025, as I’m guessing that it will become very expensive once it is approved by the FDA.

What has your experience been? And where are you located?

[andyroswilson]

I too started in May 2017 so just reaching my 4 year anniversary. Exactly the same meds as you describe ( I had a nasty bout of shingles before treatment) and no side effects to speak of although my skin is often itchy but not sure that is connected. Seems to be well tolerated. My lymphocytes are down to about 5 now - peaked at 190 6 months after treatment and on a gradual decline since - now more or less plateaued. I am based in UK. Trial was initially 4 years but extended last year in a monitor phase for 5/6 years. I don’t think there are many of us worldwide on this treatment so it is good to hook up with you.

Andy