CLL13 Clinical Trial

[Ei47]

Hi, can anyone advise me about the above trial? I have been asked to take part in this trial but am a bit concerned about side effects etc. BMB showed 90% infiltration . FISH showed no deletions. I have small lymph nodes in usual places, have good and bad days, fatigue, sweats, etc. Apart from that I am a fit 70 year old , Dx Cll 2012.

[Cllcanada Top Poster CURE Hero]

CLL13 is a large multi armed trial with a number of drug combinations... side effects would vary tremendously from arm to arm.

It would depend which arm you are randomly selected for...

They are from what I can decode...

Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe)

Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe)

Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe

clinicaltrials.gov/ct2/show...

[DaleFL in reply to Cllcanada]

This sounds like a great study design.

[lankisterguy Volunteer]

Hi Ei47,

You may be interested in this Patient Power Video:

patientpower.info/video/cli...

Near the end there is a discussion about the pros & cons of clinical trials, and especially that in the Phase 3 "double blind" trials every patient gets at least an established effective treatment. Some patients will get the new experimental treatments and do much better than the standard treatment. And all patients get much more attention from really good doctors.

As far a side effects vs. benefits of newer treatments- by the time a drug reaches a Phase 3 there are good indications that the new treatment gives many patients better results usually with fewer serious side effects than the standard treatment.

So if you don't go into the clinical trial- what treatment will you get? If the extra scans, testing and exams, visits to the hospital and all the attention from the medical team is not a problem for you, what do you have to loose?

Len

[Ei47 in reply to lankisterguy]

Thank you for your sound advise Len, I’m a little worried that I’m not ready for tx yet but I do feel a lot more symptomatic than this time last year and definitely my energy and fitness level has dropped also. Eileen

[lankisterguy Volunteer in reply to Ei47]

i would expect your CLL doctor to increase the frequency of testing and exams to 3 months or less and then gradually down to 1 month. They will be watching your platelets, RBC, hemoglobin, hematocrit as that BMB 90% infiltration increases further and crowds out the ability to produce adequate red blood cells.

When they ask you "how do you feel?" do not say "fine"! Try to quantify your "good and bad days, fatigue, sweats, etc." so they don't need to work hard to figure out your symptom changes.

All of those changes will determine when treatment is appropriate. Don't try to hide any symptom from your medical team or put windage on your answers, otherwise you will find yourself at the edge of a cliff and treatment will become urgent before you and they are ready.

Len

[Ei47 in reply to lankisterguy]

Thanks again Len. I’ll let you know how I progress. I have to sign the consent form on Wed. Eileen

[lankisterguy Volunteer in reply to Ei47]

Patient Power just published a new video that may help you

patientpower.us2.list-manag...

patientpower.info/video/wha...

Len