Trials

[21Bedlam21]

Had my appointment with my Consultant yesterday. She said no treatment yet but was repeating my FISH test as there was a problem with my last one. She mentioned that I would be eligible for a trial. I was seeking the opinion of the group about taking part in a trial. She didn’t mention what it would be. Had my flu jab yesterday and having my Covid today.

[Skyshark]

A phase 3 trial is low risk as all the dosing has been sorted out in phase 1 trials. At phase 3 the trial drug has shown similar or superior efficacy and/or better tolerability than the current treatment, either in phase 1 or phase 2 trials.

Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

bepartofresearch.nihr.ac.uk...

Sononotoclax is a BCL-2 drug like Venetoclax.

Zanubrutinib is a covalent BTKi.

The comparator arm V+O is short duration standard of care, BCL-2 drug and monoclonal antibody.

A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

bepartofresearch.nihr.ac.uk...

Nemtabrutinib (MK-1026) is a non-covalent BTKi taken continuously,

Acalabrutinib is continuous maintenance covalent 2nd gen BTKi, standard of care. I doubt any investigator will chose 1st gen Ibrutinib.

Both of these trials started late in 2023 and have end dates in 2032.

[21Bedlam21 in reply to Skyshark]

Thank you for your good advice.

[TruthJunkie in reply to Skyshark]

Isn’t trial with Sonrotoclax & Zanubrutinib for treatment-naive only? Thought that’s what I read earlier. Sorry, can’t open & read URL you attached, as am on cell phone & eyes are bad. Thank you.

[Skyshark in reply to TruthJunkie]

Both of the trials I linked to are First Line, 1L, aka Treatment naive (TN).

US gov clinical trials site

Sonro + Zanu

clinicaltrials.gov/study/NC...

Nemta

clinicaltrials.gov/study/NC...

The phase of a trial is not the number of treatments. Phase 1 determines drug dose and safety in humans. Phase 2 expands the phase 1 at the selected drug dose to find efficacy, side effects, usually looking at overall response and whether it's worth pursuing a phase 3 trial. Phase 3 is against the standard of care to find if it's actually better and/or results in a higher number of QALY's/(£/$/€). A few of the recently developed drugs have done so well at phase 1 that they skipped the phase 2.

[21Bedlam21 in reply to Skyshark]

Thank you. Everyone is very helpful.

[TruthJunkie in reply to Skyshark]

Thank you very much Skyshark!

[lankisterguy Volunteer]

Hi 21Bedlam21,

We have had numerous discussions on participating in clinical trials - there are 0ver 1900 past postings on that: healthunlocked.com/cllsuppo...

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A trial can give you access to a new promising drug (I did one in 2012 when there were no approved targeted therapies and Chemo was the only other option). And if you have the time and patience, you can help advance the science for new therapies.

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IMO- participating in most trials will likely mean more clinic visits, blood tests and likely more CT Scans and even bone marrow biopsies. It also means closer attention from a sophisticated medical team, and in the UK- likely a CNS nurse that you can reach easily when you have questions.

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Len

[21Bedlam21 in reply to lankisterguy]

Thank you. Very informative.

[scryer99]

I entered a Phase I trial in Jan 2023, the predecessor to the Phase III Sonrotoclax trial referenced above. It made sense in my situation. Trials involve more work from the patient and some risk, but that can be offset by the quality of care and the benefits of the trial drug over and above the then-standard process.

I started a lengthy thread on the reasoning leading up to trial consent and got some good responses. It's linked here: healthunlocked.com/cllsuppo...

I'd encourage you to consider trial participation. It can be a great benefit. That having been said, it's not for everybody.

[21Bedlam21 in reply to scryer99]

Thank you for your advice.