Ultra V Clinical

[Sherms757]

Ultra V clinical trial, is anyone presently on this? I’m going to be entering this soon and wonder if there is anything I should know, or ask?

[AussieNeil Partner Founder Admin]

We do have some Ultra V trial participants - check the Related Posts

[sllincolorado]

Hi Sherms757! Welcome to the trial. I have been on it just over a year and I have tested MRD undetectable in blood and bone marrow.

I have had a bit of an unusual experience but in general I have felt very good and I am pretty close to "normal".

As AussieNeil mentioned, you can find info from about Ultra V in n the related posts on the right side of your screen. You can also click on my name and then read my posts. And you can direct message me if you would like additional info.

For the short-term the key thing is to make sure that at your first infusion that you have a buzzer or something to immediately notify the staff if you feel anything "different".

Do not wait even a few seconds - buzz them right away. It is not unusual to have reactions to the first infusion as they they increase the rate. The staff can usually intervene before there is a problem. However if you have other issues (as I did) then the reaction can be a bit severe.

I know a handful of others on this trial and most of them had some sort of reaction during the initial infusion requiring a slow-down of the IV, an increase in steroids/benadryl, etc. It was all manageable. I ended up in the ICU - scary but also manageable.

Those that I know on the trial are all doing pretty well.

Drink water!

[Sherms757 in reply to sllincolorado]

Thank you! I’m new to this site I have to learn my way around don’t see anything on right side of screen, I only have an iPhone. I’ll get my kids to help me, lol

[AussieNeil Partner Founder Admin in reply to Sherms757]

If you can't find Related Posts, etc to the right, look down the page

[WDSmith]

Hi Sherms757 --

Like sllincolorado, my husband is on this trial. He is about 14 cycles into the 24 cycles and doing fantastic! We're so grateful.

As the above folks have said you can click on my name and you will see the threads where I've discussed aspects of the trial for him.

As a quick recap we've had a very positive experience with only minor hiccups along the way: He had some fatigue to battle in the early months; He has messed around with timing of the meds to find what works to have the least stomach / GI discomfort (and for him this was really just discomfort/yuckiness -- none of the harsh GI symptoms some on meds get); he had a few months with low neutrophils that sorted itself out thankfully without intervention.

He reached uMRD after cycle 5 in the peripheral blood and was deemed uMRD in the bone marrow at the halfway point (trial protocol on the testing -- we think that was probably true much sooner.)

Did I mention we're super grateful?

BTW he's treated in Nashville by Ian Flinn, FYI.

On what to ask: Is this the Phase 3 trial of Ultra V? I assume you are entering Phase 3 of this UltraV trial and will thus be randomized into either the 3 drug arm (Umbralisib, Ublituximab and Ven) or the 2 drug arm (Umbralisib+ Ublituximab)? When my husband (and sllincolorado) entered the trial it was in Phase 2 and only had the 3 drug single arm so we knew for sure what drug combo he would get.

Since you might receive the 2 drug (U2) combo you might want to read up on the Unity trial -- which has been testing that drug combo. I believe the 2 drug trial has been showing good results too.

[Sherms757 in reply to WDSmith]

Thank you very much! I attached my drs answer when I asked him a question. He did mention at last visit that he has not heard anything yet but thinks this trial may finish by the end of the year. With this being randomized do they ever tell you exactly what your getting? Also wondering about getting a port as he mentioned it’s not required but maybe 🤔 preferred

[Sherms757 in reply to Sherms757]

Couldn’t figure out how to attach drs email but what he told me was: Randomized to Ublituximab/Umbralisib (which he said he has used before in patients with good success) OR UP plus Venetoclax. He also said ports are not required but often preferred.

[sllincolorado in reply to Sherms757]

I did not have a port for this trial. Personally I did not want that constant reminder that I was in treatment but I also did not want a potential infection site. If you have decent techs and do not have a physical reason why a standard iv wouldn’t work I would skip it.

They used heating pads on me to make the iv insertion easier. It never bothered me once I was hooked up.

It is preferred by the medical team because it makes their job much easier but I don’t think that is a good reason to have one.

[Sherms757]

For anyone who knows about the Ultra V trial, did you gain weight and did they give steroids with it?

[Bforever]

I start cycle 2 of the Ultra V trial tomorrow. I receive Dexamethasone before my infusion of ublituximab, No weight gain, just a little jittery the next day.

[Sherms757 in reply to Bforever]

Thank you. I’m starting phase 3 as soon as I get the scans and BMB done. I’m doing a clinical trial and today the research nurse told me the two U drugs are part of the A arm and adding the Venetoclax is a different arm. The trial pays for the 2 U drugs, but the Venetoclax is commercial. Has anyone else done this Ultra V in a clinical trial? Did you have to pay anything?

[sllincolorado in reply to Sherms757]

Hi Sherms. I am on an earlier phase of this trial. I work full-time and have insurance through my company. The venetoclax goes through my insurance but pretty sure that drug company has grants to cover most of it. My co-pay is $5 per month.

However, if you are medicare I think the payment situation is very different. If you are on medicare, ask the clinical trial nurse for how other people on medicare have paid for the venetoclax. If the nurse does not have a good answer have her contact other people involved in the trial. There are many resources to pay for this type of drug but not always easy figuring out the details.

I would get all answers in writing so you don't have any big surprises.

I know two people on medicare on this trial and they have two different situations:

1. Person1 has income lower than $85,000 per year, they have medicare part D. They received a PAN grant to cover the rest.

2. Person2 has income over $85,000. They pay about $700 per month.

These are only two examples, if you are on medicare it really depends on what type of plan you are on. There are also other organizations in addition to PAN that provide financial assistance. I am not sure if they all have financial requirements.

If you need more info let me know and I will try to find you some resources.

[Bforever in reply to Sherms757]

I am also in Arm A and I start Venetoclax next month. It is FDA approved and my insurance will cover it. My husband is retired military and that is my secondary insurance I use for drug coverage. I also have Medicare but not part D. Good luck with trial.