ULTRA-V trial discontinuing

[beanlake14]

My second post in a day. I wanted to share how my doctor approached TG Therapeutics pulling the trial as well as not seeking umbralisib FDA approval. I was in phase two and finished venetoclax and ublituximab a year ago. Because I didn't quite reach MRD negative (blood did; bone marrow did not), we decided I would stay on umbralisib. As several of you have written, FDA approval is not going to happen. There were more deaths in the experimental arm, but these could have possibly been due to covid and other causes. Bottom line, the company will allow me to stay on umbralisib if I choose to. My doctor would not advise me either way because although I am doing fabulous as far as most blood counts go, there is no way of knowing what long term toxicity would be. Also, and here is the kicker, there is no way to no if I am doing well because I stayed on the drug or if I would be doing the same without it. If I go off, I can't go back on or obtain since the FDA won't be approving. For now, I have decided to stay on umbralisib since I am doing well. I can go off at any time and still be monitored. It was a confusing choice, but I am comfortable with it. I wasn't sure how many of you are in this same position.

[WDSmith]

Thanks for that update!

My husband is due to wrap up the Ultra V within the next week or 2. At last conversation (just before TG pulled their applications) his oncologist was of the mind to stop all treatments when the 24th cycle completed. His reasoning was that he wanted him off all meds so he could hopefully get a covid vaccine that would work after some time... thus far no dice with his 3 doses. To my knowledge Dr. Flinn's thoughts were not dependent on the TG situation, though that situation has changed as we know recently.

He has had MRD testing done in blood (waiting on results) but last we talked they weren't planning on a BMB at this time for that testing.

We'll see -- he goes back on Tues next week for those results and conversation. I'm betting he's off all meds. I know he's ready to be done with all of the pill taking! lol

[beanlake14 in reply to WDSmith]

Agree. I’m still pondering my decision. Luckily. I can change any time. Do you know how many total were in the study? I mean I know 54 died in control and 58 in the study. Dr H said that could have been Covid, etc. but I forgot to ask and couldn’t find how many were in phase two study.

[richutchens]

I was put in the Ultra V trial nearly 2 years ago. I was one of many who did very poorly and I was taken off after 6 months. I nearly died from it. That said, the little amount of time that I was in the trial put me in, so far, a 15 month remission. I’ve had 5 negative MRD. I have no residual effects accept I am now lactose intolerant which I was told was a common side effect. I’ve since gone vegan so I don’t really care. I wish great results.

[beanlake14 in reply to richutchens]

I ended up in the hospital with tumor lysis after the first one, and I too, almost died. Not sure why I didn't quit then, but I stayed in. Lots of bumps for the first few months, and then things settled down. I am so glad it helped you.

[richutchens]

I’m pleased that they killed the trial. But it was a trial and I knew the risks going in as with all phase 2 trials. I have no lasting effects other than stated.

[sllincolorado]

I hit mrdu at the the first test and remained mrdu at the 2nd (6 months apart?). 2 months before scheduled to end trial everything fell apart. Platelets crashed you name it. I’ve been in the hospital a month and currently my biggest problem is not the CLL. Fungal infection because I have no immune system. It’s in my brain. Could be dead in a few weeks. I’m glad ultra v has been successful for many. I think for me it was a poor choice but not sure we could have predicted this. They can separate out the covid data - that shouldn’t be an excuse.

[beanlake14 in reply to sllincolorado]

You guys make me wonder if I should reconsider staying on umbralisib. I just don’t know-especially what future toxicity would be. I am so so sorry you are in the hospital. I pray for your recovery.

[CLLerinOz Administrator Volunteer in reply to sllincolorado]

So sorry to hear you’re still doing it tough. I’d hoped things might have started improving for you after so long in hospital. Wishing you better news in the days ahead.