Clinical trial with Acalabrutinib and Obinutuzumab

[Reflectionofsky]

I have the opportunity to be part of a clinical trial. The purpose of the study is to understand if early intervention (people on W&W in the high or very high risk group of needing treatment in the next 2 years but current protocol would not yet be treated) of CLL/SLL using targeted therapy will lead to sustained long-term remission and decrease secondary complications such as cancer and risk of serious infections. The targeted therapy is Acalabrutinib and Obinutuzumab. I would appreciate hearing from people that have had these two drugs. What was your experience? I am struggling with the decision of whether to participate in the trial. Thanks.

[Smith123456]

if you don't take it and then down the road you want it you may not get in. Just a thought.

[UniversallyPersonal]

I have taken Obinutuzumab, it was for me just like Rituximab. I had no bad reaction on either. Just a tiny bit of a warm feeling in my cheeks. It seems to be very individual how people react to them, I didn’t react at all but I saw another patient stopping and starting continuously with allergic reactions. She still got through it and I think the next round was easier.I haven’t taken Acalabrutinib, but from my understanding it is supposed to be less sideffects than Ibrutinib. For me Ibrutinib was absolutely fine.With a trial that combine two fairly known drugs like this I would think the doctors investigating know very well what adverse side effects to look out for and it would be quite safe.

If you don’t join the trial, your next treatment might be Ibrutinib? If you expect treatment soon anyway it seems a reasonable trial to join.

Make sure you ask all your questions to your doctor. A good one is always, “what would you do?”, or “would you recommend it to your brother?”

-G

[SofiaDeo]

I've always liked trials of already approved drugs that I would consider taking anyway. The monitoring is top notch, by expert docs, and often the copays are waived for Dr visits & some tests like CT scans. This all depends on the trial, you have to ask ahead. I have a $50 copay to see specialists, so last year saved hundreds of dollars on that alone when I was on a study. I paid the doc a few hundred dollars only, with multiple CT scans, bone marrow biopsies, and weekly blood tests. If not for the study, I would have paid waaay more for that monitoring. And once you have spent some time as that doc's patient, even if their practice is technically "not accepting new patients," you can often continue with that doc after the trial, they are usually interested in continuing with a study patient.

I haven't answered your question re: acalabrutinib & obinutuzumab, I haven't taken those specific drugs, just trials in general. One caveat: on an already approved oral medication like acalabrutinib, make sure to ask if the drug company or other foundation will pick up the drug cost if the study isn't paying for it. Also ask how the obinutuzumab is being paid for, and if you have insurance copay or coinsurance due for outpatient clinic infusions, and who is paying for that. Unlike studies of decades ago (which sometimes even paid us, or gave travel/hotel reimbursement), sometimes studies will want your insurance carrier to pay for the oral drug if it's considered "approved therapy" like acalabrutinib is. I don't know about outpatient infusions, I haven't had any yet so zero experience. If you aren't on Medicare, you need to check your policy for "lifetime maximum benefit per disease state", in addition to any copay/coinsurance if the study is billing your insurance.. If you have a relatively low "lifetime maximum", you may need to do some math to figure out if you're going to start paying for CLL care years before you planned on, because you used up your benefits in a trial, if the study isn't paying. Studies often do more than bare minimum monitoring & tests, and this adds up. The study will often bill your insurance for tests, since this "level of care" is needed by the doctor doing the study. If you are on Medicare, you definitely want to see about foundation or drug company help with the drug cost or you will have to pay your copay, and also even if the study offers to pick up the copay, if the majority of the cost is being run through Medicare, you will hit any donut hole and have to pay THAT, until any donut hole ends, up to your yearly out-of-pocket max, unless the study offers to pay it. Ask up front what costs you are responsible for, do some calculations, and go back & try to negotiate. Someone dropped my blood tubes one week and I was unwilling to drive the 70 miles one way to give more blood so they sent a nice car & driver to get me for more, so go ahead & ask. And get it in writing, what they will pay for, and what you are responsible for, don't potentially misunderstand.