Hi all, I have two options after progressing on IB after four years.
A) LOXO 305 Trial (Bruin 321)
Or
B) Venetoclax and Rituximab
Being 17p deleted I was thinking of going forward with Option A assuming I was selected.
But maybe Option B would be easier since they’ve already been approved .
Just not really excited about all the testing that comes with a trial. (Option A)
Any comments welcomed.
I'm not familiar with that trial. In the trial if you don't get chosen for LOXO, what is the other drug they give people to compare? Or does everyone get the LOXO just different dosage?
I had V plus R and was TP53 (17p deleted) which scared me, but V plus R succeeded am off it now monitoring. Everyone is different, I had an uncle pass away who it was not successful for.
If you are not older than 70 the venetoclax with retuximab is a good choice. Those over 70 tend to have more side effects with the retuximab when combined with venetoclax, if I remember the study correctly. Also, Loxo 305 has some very good responses as well.
Since I'm a fellow 17p (with bonus issues), while I don't have advice for which option I'd take, I do hope you post your decision and how it goes.
Hi there, I have just started the Bruin 321 trial at Princess Margaret in Toronto. There's 3 arms to this trial and it is a randomized trial. After your data is inputed into the computer it spits out what arm you are on.
Yes there is a lot of testing done in work up to the trial but what I found it has given me a complete insight, more in depth. Some things not even related to my CLL have been found and are good to know for the future.
I got randomized to Arm B which is Idelisamab and rituximab ( 6 months ).
I also just finished 5 years on Ibrutinib and my next step would have been Venetoclax but as explained to me if/ when arm B stops working I will be switched over to the new trial drug (Pirtobrutinib) for as long as it is still working for me, so the Venetoclax I will have saved for the future if all else stops, so I know my future path for hopefully quite a few more years.
Also, under the trial all your drug costs are covered by the drug companies while you are on the trial.
Good luck with your choice.
Jack
Hi Jack, I am going to Princess Margaret on Monday to start the screening process and we’ll see what happens.
If I get accepted I’ll do it and as you say keep the V + R as my Ace in the hole for the future.
I’m 61 and working from home.
Have you been taking Allopurinol?
How have you been doing on Arm “B” ?
Cheers
Steve
Hi Steve, I just had my first Rituximab infusion on Monday of this week, it went better than I thought. I am also taking the Idelalisimab pills twice a day. Rituximab infusion will be very 2 weeks at the beginning.
Yes I am taking Allopurinol plus 2 antibiotics for at least 2 weeks. So far all is going good, no problems.
I am 76 and retired and was originally diagnosed with Trisomy 12 but after IB stopped had another Fish and found out I acquired 17p deletion plus a couple of others along with my Trisomy 12. Lucky me..haha
PMH doctors and nurses have been wonderful.
Good luck,
Jack
Hey Jack, they asked me to stop taking Acalabrutinib for the two week period before starting the trial.
Did you do the same?
Yes, I stopped my IB 2 weeks before and it looks to me that you will be on the trial unless something changes with your tests because that's the same path that I followed. Do you know who your DR. is whose looking after you on the trial, Christine Chen is the head investigator
I’m going to see Christine Chen on Monday. I’ll be doing blood, CT scan and then signing the consent form.
Must have been nerve wracking giving up the IB for two weeks I bet?
Yes it was but after my first blood draw I was surprised that my counts didn't go up all that much and no other changes.
Well good luck on Monday and maybe we will run into one another at PMH.
Jack
Hi - if you have had to give up Ibrutinib because of side effects or no longer working, then I'd say give the Loxo trial a go. I am coming to the end of my 3 years of the trial and it has been a life saver for me - quite literally. Although it's still a BTKi, it actually works in a different way to Ibrutinib. 3 years ago I was in a similar position to you - Venetoclax of the Loxo trial. Because I had such bad side effects from Ibrutinib, my consultant was concerned that the Venetoclax would also cause me problems - hence the decision to go with the trial. Good luck with whichever you decide!
Thanks UK I appreciate your input .
Are you still taking the LOXO 305 after the trial was over?
I am hoping to. According to the protocol, I should be able to, but I think it will be down to the hospital admins as to whether they will allow me to take an unlicensed drug, off trial. Fingers crossed!!
I am on a trial for Pitrobrutinib. I had not been treated prior to starting the trial on November 1st. Compared to what others have posted on here about side effects from V&O or the covalent BTKs, I feel like I ‘m very lucky.
The most difficult side effect I’ve experienced is skin rash. It seems I can develop one from sweating while exercising or various ointments I used to use but now obviously don’t. But it’s so far been very manageable.
Importantly, no headaches or heart issues or bone pain or muscle pain of any note. Occasionally when I first wake up I feel some mild pain in my joints, different from arthritis pain. But once I get up and move around the room, it vanishes.
I didn’t enjoy the bone marrow biopsy but it didn’t hurt either. I could feel tugging but never crossed over into pain.
Good luck with the screening!
I’m not a fan of the bone biopsy but it was bearable.
Hoping to get into Arm A and start Pirtobrutinib by Fed.
All the best
I have been on Acalabrutinib for 2 years and I’m 17p (P53) deleted. My specialist at Sunnybrook has mentioned that when my cll starts to progress, Pirtobrutinb would be the next therapy of choice. He’s hoping that by the time I need to move on, Pirtobrutinib will be approved and available in Canada
That’s very credible advice since the LOXO-305 is in Phase3 at Princess Margaret it’s only a matter of time before it’s approved.
This is the dilemma I was faced with: do I go with V+R and wait for Pirtobrutinib to be approved or just jump right into the trial now and keep V+R as my next treatment
I think you have probably made a smart move especially given the side effect profiles for the two alternatives.
I will be starting Pirtobrutinib tomorrow at PMH. Wasn’t sure what Arm of the trial I would have been selected for but Arm A it is.
Thanks and stay well
Steve
Excellent news!! Looking forward to hearing how you manage with Pirtobrutinib. As I mentioned, it seems to be the current therapy of choice for my cll specialist at Sunnybrook should Acalabrutinib stop working.
BTW, my wife and I caught COVID right after I responded to you a couple of weeks ago. As soon as I tested positive, I got Paxlovid from the local drug store. As of last December, the pharmacist can prescribe Paxlovid in Ontario without a doctor’s say so and the cost is fully covered by the province. I was over COVID after a couple of days whereas my wife, with strong immunity, is much more slow to get over it.
We have been sheltering for 3+ years, fearing the worst, and probably thanx to Paxlovid it’s turned out to be a mild flu (at least for me). This event has been freeing - we will still be careful but we can see friends and family and travel again.
Good luck in your trial. Hope it makes your cll journey much more pleasant and uneventful for years to come
Watch and Wonder, but Do-no matter what stage!!!
Just not sure what we can and can't do 
What do you do when you are MRD Negative?
What kind of fatigue do you have?
What can’t I DO while on treatment?
