ULTRA V Phase 2 Trial

[Dontgothere]

Can anyone tell me about any adverse events they have heard about thus far or the Side Effects of Umbralisib?

[richutchens]

It has been a challenge to say the least. It is a slow process and fatigue is incredible. I am in cycle 5 of the phase 2 trial. I am 71 years old. I have a friend on the same trial and he is around 47 and he feels the same way. We both go to Mayo Clinic in Jacksonville,Fl. It is a wonderful opportunity to be admitted in the trial if you can but just know its not for the faint of heart. I feel you want an honest opinion. It would be nice to know what results to expect at the end of the two year trial but being in phase two I have no read anything about results. This is my 3rd trial, the other tow being Gazyva and finally Ibrutinib. The former i was on for two years and was taken off due to afib. I was in near remission for 15 months afterwards but it has come back with vengeance and they put me in the Ultra V Trial. I'm here for you. My glass is always half full so just know that. I am not a negative guy but I want you to know my experience. You will be taking several medications at one time and 6 IV treatments over 6 months.

[Dontgothere in reply to richutchens]

Appreciate your honesty. I am trying to decide between 2 options. Gazyva + venetaclax versus the Ultra V study

[Canuck901 in reply to Dontgothere]

The Gazyva and Venetoclax combination has much more data and has been fast tracked because of its succsss and it has been around longer than the the Ultra V

. Which is in phase 2 trials

[sllincolorado]

Just wrote a small novel about my experience on Ultra V - Cycles 1 through 3. Have not started venetoclax yet.

healthunlocked.com/cllsuppo....

[WDSmith]

My husband is on this trial (in Nashville). He is on the eve of the Venetoclax cycle (cycle 4), starting on Tues this week. I'd be lying if I said we weren't nervous. lol

He is 57 and in excellent shape (other than CLL...) . Avid cyclist and runner and general healthy guy. This is his first treatment.

When we were where you are we also debated the Ultra V trial vs V+O. Here is the thread where this crowd helped me think through it some.

healthunlocked.com/cllsuppo...

And then here is our update after Cycle 1 started:

healthunlocked.com/cllsuppo...

And finally after Cycle 2:

healthunlocked.com/cllsuppo...

Since then Cycle 3 was pretty uneventful except for liver numbers on day 1 were elevated so they had him back 2 weeks later for recheck. They were lower at that point so no change was made to his meds, etc.

As sllincolorado points out in her update post of today there are several other meds they put you on. For him:

Started before Cycle 1:

Dapsone: an anti-infective medicine that fights bacteria;

Valaciclovir: Antiviral drug, including shingles, cold sores, chicken pox, herpes.

Starting now, just prior to Cycle 4

Allopurinol: used to treat gout, high levels of uric acid in the body caused by certain cancer medications, and kidney stones.

So far he really can't complain about the trial when compared to others.

To your original question, David does not seem to have had any adverse effects from the umbralisib or any, other than the fatigue, which for him faded after 2 month. Prior to the trial he was already a compulsive hydrater (for his whole life) so has certainly maintained that throughout. He also has played around with the timing of the meds to minimize some ill effects from those.

Now we wait to see what the addition of the allopurinol and venetoclax brings...

Wendy

[Decorateshouses]

I was in a trial for Umbralisib and Ublatuximab with Pembrolizumab 3 yrs ago. It was an infusion every 28 days for 6 cycles.Lots of fatigue and weakness. Had to stop the trial due to toxicity after 1 1/2 yrs. However, I remained MRD for 24 months following the discontinuation of the trial!

After a relapse in Jan 2020. I am now on Venetoclax and have finished my 6 month cycle of Gazyva. The ramp up with this treatment was a rough go. But 6 month scans showed lymph nodes are gone and spleen is back to normal size.

Hopefully this gives you some insight to make your choice. It is not an easy one, nor is it EVER a one size fits all solution when it comes to cll.

Best of luck to you. Stay strong.

[DriedSeaweed in reply to Decorateshouses]

Did you get the sense it was the umbralisib that caused your fatigue on treatment? Or just that you were being hit with a three drug combo?

[Decorateshouses]

I had fatigue with my first trial involving rituximab. When the infusions ended, fatigue improved. Same with my current treatment. When Gazyva ended, the fatigue improved. It didn't improve 'sustainability" after Umbralisib was finished. I also had reactions at the IV site, i.e. rashes and swelling of my arm for a few days following. So, it is possible that the combo was more responsible for the fatigue than Umbralisib alone was.

Hope this helps.