Yesterday I started a new clinical trial at UCSD for people that have relapsed on Ibrutinib. I had been a part of the RESONATE trial and have been on Ibrutinib for 4 1/2 years. Early this year began a trend of increasing ALC and enlarging lymph nodes. A next Gen Sequencing test showed a mutation in the C481S gene, confirming that eventually Ibrutinib alone will become ineffective. This trial is trying to determine if by adding Venetoclax, it will block additional pathways and may event delete the C481S mutation making Ibrutinib effective once again. In untreated patients the trials have shown that there is synergy in combining Ibrutinib + Venetoclax. So the hope is that even in heavily pre treated, complex karyotype (I am both of these) that there still will be a response. The main problem with this trial for those of us with Medicare Part D, is that I am responsible for the Venetoclax co-pay, which will be about $10,000 for this year. The Ibrutinib will be paid for in the trial. I know this sounds crazy for a trial, but the main reason is that they are going to test a non-standard dosage of Ibrutinib, while the Venetoclax dose is the standard 400mg dose. Hence, Venetoclax is considered 'standard of care' for relapsed with a 17p deletion. No issues so far, but I am only on day 2. But I have never been so hydrated. I am considered 'low risk', so doing the standard 5 week ramp up of the Venetoclax to get to 400 mg. More to come.
Terry Evans
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Teegolf47
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I have known a few who have been able to access it 'off label', usually 3-4 line. It should be more readily available this year in the U.S. second line, in combination with rituxan... I think it's in the FDA... at the moment for this indication...
May I ask someone to please define what "off label" exactly means? I am assuming I understand what everyone means here, but just thought I would ask to be sure.
Once a drug has been FDA approved for a condition it usually is for a specific disease and/or condition. For example. Venetoclax was approved for CLL patients that have had one prior therapy and have 17p deletion. Once it is approved a physician can write a script for other situations like a relapsed patient with 11q or a treatment naive patient with 17p. Or actually any condition. The hurdle now would be to get the insurance company to pay for the drug ‘off label’. Sometimes the will approve it, sometimes not. If you are rich you could just pay for it yourself and skip the insurance hassles.
Thanks so much for this explanation. I can understand how this type of access to certain drugs is extremely important for some people. In the future it could possibly be very important for me as well, only time will tell.
I agree with Chris, it would be 'off label' and usually the justification written by one of the top CLL docs like, Furman, Kipps, O'Brien, Byrd, etc. They have been known to work miracles when it comes to getting approval for non FDA approved therapies.
What won't they think of next to not pay for our Cancer treatment?
I hope things go well for you and that this is your ticket to stop both meds. and have a long remission.
I suspect the new tax laws that have messed with our coverage and saved the government and insurance companies money.
I just read the following, which affects personal income tax filings, is in the new tax laws.
Repealed: A credit for 50% of the cost of clinical testing of drugs for rare diseases and conditions.
Repealed: The deduction for medical expenses exceeding 7.5% of adjusted gross income has been repealed. Supposedly, to allow a tax code that lowers insurance rates every year for the rest of your life.
I don't know if the new law, just signed today that allows any new drugs in the pipeline working to be approved to be used for those in terminal situation who want to try them, is because of the repealing of the first mentioned repeal.
According to a summary online of the tax changes for 2018 tax year, individuals can claim medical expenses over 7.5 percent of adjusted gross income. It appears the law did not repeal but did modify. The previous law was you could only claim medical expenses over 7.5 percent if you were 65 or over. Otherwise the ceiling was 10 percent for everyone else.
Hi Terry, It is good to see that there are trials taking place for post Ibrutinib treatment and I wish every success for you and the trial. I had my baseline CT scan today in preparation for my imminent Ibrutinib treatment, I am also TP53/17P mutated, been on W&W for the last 8 years. I have a strange mixture relief and apprehension as I approach this new phase of my journey but I know that I am very fortunate to have this treatment for 1st line treatment. Best wishes.
Interesting concept. It’s going to take two years to learn whether all of the patients now failing on ibrutinib should stay on it while Venetoclax is introduced In meantime It maybe wise to stay on ibrutinib for those not in trial at usual dose until study is completed. Is there a no ibrutinib arm to see if none is same as ibrutinib arms? Sure would help knowing whether the benefits outway the costs involved for both drugs on Part D 20$k/yr
Since one of the requirements of the trial is that you are relapsing on Ibrutinib, there is no arm of Ibrutinib only. It makes sense to create a trial for those people that are still responding to Ibrutinib and add Venetoclax to see if they can get to MRD- status. But I don’t know if any like that yet.
I’m on a treatment naive trial for I/V and also in the midst of the ramp up phase. I’m on week three at 100 mg. This sounds like a very interesting trial and I wish you all the best!
You may want to ask your CLL expert doctor that is running the trial to go to bat for you with Genentech Venclexta Foundation (800) 530-3083
Dr. Furman's staff did the paperwork and I have been getting Venclexta since June 2016 at no cost, no charge to my insurance. They just called me yesterday, reviewed my case and approved me for the 3rd year.
I am Trisomy 12 UnMutated so it's a "Off Label" prescription from Dr. Furman.
PM me if you want the name and email of Dr. Furman's PA that wrangled the paperwork.
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18 month Follow up results with Ibrutinib/Venetoclax clinical trial
Untreated Aussies needing treatment - great clinical trial just for you
This trial is going to reopen- Called CAPTIVATE. Ibrutinib plus venetoclax study sponsored by Pharmacyclics - Study Number PCYC-1142 . 
