Having MCL and CLL/Trial question

[Conehead]

Previously I asked if anyone had MCL and CLL. All replies said that is very rare. Well I found out I only have indolent MCL. Thank you everyone who responded to my post. My new lymphoma specialist wants me to be a part of a trial. Please let me know that good the bad and the ugly of participating in trials. Thank you so much for everything. I can only hope I am able to find a site like this for MCL.

[AdrianUK]

The crucial thing about volunteering for a trial is understanding both trial arms and also what treatment you’d get outside of the trial. You should feel that both trial arms are at least as good as what you’d get regularly. If you are satisfied of that often in a trial you might get access to newer hopefully better treatments. But of course if there is a great existing treatment that has more evidence supporting it some people are going to want to choose that instead.

If can help to discuss the study with a doctor not involved in it ie a second opinion. Once in a trial you tend to get great care maybe more attention than usual but perhaps more tests and investigations than usual too. It might mean for example access to MRD testing to see if you have residual disease after treatment which might not be available outside a trial. It could mean more CT scans though too which can be a concern.

Sometimes it can be quite a relief to allow a computer to choose your treatment for you if you aren’t sure what to go for I know it was for me as I told myself that I had in my case a 1 in 3 chance of having whatever would turn out to be the best treatment for me at the time which might not be the same as what the best treatment for a group would be. But if you want control and choice over what treatment you get then obviously a trial isn’t for you.

It is a good feeling to know you are helping future patients learn what is the best treatment for them. And of course just like outside of a trial if a particular treatment doesn’t work for you then you can always stop the trial and be switched to something else.

Trials aren’t for everyone. But I for one am glad I chose to volunteer for one.

[Conehead in reply to AdrianUK]

Thank you for your response! Truly helpful!!!

[Hidden]

is this a usa trial or uk trial . you spelled hematologist usa way in prior post

[Conehead in reply to Hidden]

A US trial

[Hidden in reply to Conehead]

would be helpful to know which trial . could you provide a link?

[Conehead in reply to Hidden]

I do not have a link. I was given a packet at the hospital. Study ID HUM00146986

IRB: IRBMED . This is from the University of Michigan. It is for MCL. The test is for adding Venetoclax to already approved drugs Lenalidomide and Rituximab.

If you can offer any insight I would truly appreciate it.

[AussieNeil Administrator]

Trials are not necessarily multi-arm, but you should expect to be offered a treatment protocol that has evidence that participants are likely to respond at least as well as an approved treatment. Be aware of the differences between phase 1, 2 and 3. Phase 1 is where the therapeutic dose of a new drug is determined and I would expect that you would be offered a phase 2 or better trial: en.wikipedia.org/wiki/Phase...

That's because we've reached the stage of knowing what drugs work well with CLL and MCL and are now experimenting with combination trials and second generation versions of proven drugs, particularly the BTK inhibitors, but there is also a new BCL-2 inhibitor in trial following the success of Venetoclax.

The good news for you is that CLL drugs work well on MCL, though the dose may be different (560mg of Ibrutinib per day for MCL vs 420mg per day for CLL). The Venetoclax and Ibrutinib combination is looking promising. nejm.org/doi/full/10.1056/N...

Neil

[Smakwater]

Conehead,

In sync with what Adrian and Neil stated, it is important that your treatment objective is conducive with the trial objective, and that you have a plan for continuation in the event that at some point the the trial protocol cannot meat your needs.

Discuss this with the trial administrator, hopefully, they are either your attending oncologist, or willing to continue with you beyond the trial parameters if need be.

JM

[avzuclav]

Depending on your markers, some MCL can be classified as "smoldering" where watch & wait is sometimes prescribed similar to CLL. source: ncbi.nlm.nih.gov/pmc/articl...

I only mention this because occasionally on this forum we see CLL patients who are immediately prescribed treatment in cases where CLL experts would have prescribed watch & wait.

[Conehead]

Thank you for everything. I am digging deeper with the items you referenced.

[pollyg2016]

If you search in the HealthUnlocked search section and type in MCL there is a section for Non-Hodgkins Lymphomia you should find some help there. It use it all the time for help and information. My partner has MCL also and has just finished 6 months treatment on Rituximab and Bendamustine. He was previously on Ibrutinib after 1st relapse. We had a consultation on Friday only to be told that the treatment hadn't worked, unfortunately. So we have another appointment next week to find out the next course of action. Very disappointed, as the R&B treatment was hard going for him. But we are staying positive and the Consultants says his condition isn't good or bad just stable. What trial are you going on?

[Conehead in reply to pollyg2016]

Thanks for the tip! I guess it is not really a trial. It is a research study at the University of Michigan. The purpose of the study is to determine if giving venetoclax in combination with lenalidomide and rituximab is safe and effective for MCL. Blessings!

[randomacts]

Not surprised, MCL is often slow to be diagnosed. There is a good support group on Facebook called Mantle Cell Lymphoma Support. They are a smaller group and there is more expertise on this CLL group, but they are very kind and supportive. One thing they will invariably tell you is to seek the advice of an MCL specialist. Which we didn't, but being on the group is kind of a way to double-check that my husband's treatment is standard of care. And the treatment of MCL is somewhat different than CLL. Even from one MCL to the next, the presentation and progression are different, the genetic markers are different. So what works for one person won't necessarily work for the other.

Just like with CLL, with indolent MCL it is common to put off treatment as long as possible. But there is a bigger reason to watch and wait, and that is because MCL develops resistance to a particular treatment more readily than CLL.

As far as entering a clinical trial, I think within your physical ability it's a good thing. They are always short of MCL volunteers because the population is so small. You need to be okay with getting into either the treatment or the control arm.

The point with indolent MCL is to kick the can down the road as far as possible while doing the least amount of damage possible. What is in the clinical trial pipeline right now is a vaccine. news-medical.net/news/20200...

Venetoclax appears to be a safe addition that will lengthen` remission. With lenalidomide I think the kidneys may need to be evaluated and monitored.

healio.com/news/hematology-...

[Conehead in reply to randomacts]

Thank you so much. All very useful information!!! I will definitely check out the MCL support group on Facebook.