After 15 Months on Imbruvica plus Venetoclax Captivate trial out of UC San Diego I am MRD Negative in the Bone Marrow and blood down to 1 in 10,000 cells. This is very good since I am 17P Deleted with Trisomy 12 Unmuated Cycto Genetics. My numbers are all mostly good. WBC is 3, ALC is 0.9 ANC is 1.6- which was low for a while. PLT is about 120 which is staying a bit low.
I don't know how much it helps but I eat mostly Vegan and drink a lot of high quality green tea and OJ with fresh Turmeric in it. I try to get plenty of rest and excercise. I do Yoga. I jump on the trampoline every day to keep the nodes moving. The vegan was hard at first but there are many very good meat substitutes now. Being Vegan helps one body and the planet!!
My side effects have not been too bad. My brittle finger tips and some fatigue has been probably the biggest issues.
Over all I am very very lucky because I got a second opinion from UCSD and then waited for this trial. I was on WW for 1 year - in that time my nodes got huge! I go to Dr. Kipps and Choi who are some of the best CLL doctors in the world. CLL Society run by Brian Koffman was very helpful as well.
They helped me understand what was possible. I donate to them when I can.
Now in the trial I will be randomized to get either Imbruvica or a Placebo and the big question is will my CLL stay in remission. Especially if I get the placebo arm. If it comes back I will go back on I plus V. I am told by by UCSD that many people on Venetoclax plus Gayzva are staying in remission after about 2 years but others have had to go back on the drugs.
In my opinion If we can pulse the medications on and off that could at minimum buy us time. Time is key since there are so many new treatments coming.
Note: this trial is suppose to be reopened at 6+ locations but is filling up fast. I know San Diego, CA and Rochester, NY are 2 location. Find out the sites and call the contact person.
But isn't that combination very expensive some people are not gonna be able to afford that, and how come doctors don't prescribe them both together if it's so effective? I would have to move to another country here in the U.S. healthcare is not free.. Please correct me if I'm wrong.. Lydia☺
Lydia, you are correct that there is a cost to the drugs and my understanding is that it is quite high. I'm not sure how high as I am in the UK.
The cost of drugs to end user in the UK is managed through the NHS (National Health Service). According to The Kings Fund (an organisation that monitors this) about 98.8% of costs are paid via general taxes and National Insurance contributions we, the patients, make and 1.2% is via patient contribution. So for example if I go to the GP and get prescribed a drug I pay a standard prescription charge of £8.60 presently, regardless of if it is for a £1.00 drug or a £200.00 drug. GPs cannot prescribed this combination currently as it has not been approved for general use.
The system in the USA is quite different, Insurance based I think.
As I said, they are not prescribed together today because they have not been approved together, that is what the trials (that people like Hoffy, myself and others are on) are testing. In the USA I believe it is the FDA that control what can be prescribed and in the UK NICE control the approvals. To get drugs approved takes quite a lot of lab testing then trial based analysis. Until drugs are tested together nobody knows if they will react well or badly.
My hope for you is that by the time you need treatment(if you ever do) then these will be out of trial - and you never know, even the next generations of drugs will be tested as well. This is a moving target so, within reason, the longer you wait the better it will be for you.
Both drugs are FDA approved for CLL as mono therapy. The issue is to have the FDA approve the combination. The endpoint of this trial is MRD negativity and the FDA is used to endpoints like PFS and OS, not MRD. It remains to be seen if they decide to give it a shot.
However, in view of the fantastic results, it is very likely that oncologists won't wait for a FDA approval and will prescribe both drugs for treatment. They are both ON label after all, meaning they are both approved for CLL.
Insurance companies might challenge the oncologist but you can challenge them back with evidences that the trial works and they are both FDA approved for CLL. 15 months of Ibrutinib and Venetoclax is way less expensive for an insurance company than a lifetime of Ibrutinib. Do the math, they will too.
Hopefully they reduce prices for the combo. Both drugs are owned by the same company.
On the clinical trial drugs are free!!
Once approved if it is prescribed your insurance will have to pay for it. Although you might have a high deductible to start or something like that. There are programs from the company to help pay for drugs as well and other organizations
Fabulous news and I have to agree that in theory pulsing I and v on and off should stop the body from becoming resistant I'm going to a conference in 2 weeks in Leeds where they are running the same trial with great success. I myself am on ibrutinib 10 months with 17p and been told I'm in remission which I guessed bas I feel great . But I'm still interested in learning More and see the benefits of what you are doing certainly the chicken and egg using both at once but as I have said in theory it makes perfect sense
What fantastic news! I'm on the I/V trial as well and am hoping for remission at my next BMB on the 19th of this month. Your photo is perfectly appropriate! Kudos!
Fantastic news Hoffy! You must have been one of the first on this trial. I'm booked in for my BMB tomorrow morning (same trial) to see if I can joing your mrd- club.
Yea! So glad to hear the promising news. Please keep us all up to date on your progress. I've been on Imbruvica about a year and look forward to posting a positive post too. You give me strength.
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ASH 2019: U-MRD by subgroup (ibrutinib+venetoclax) CAPTIVATE trial
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