Fixed Duration A & O Phase 2 Study...anyone?

[Bethro]

Hello to this wonderful community and happy holidays to all! I have been clicking and reading and listening for the past 20 years while on w&w. I was diagnosed in 2001 (at 34 yrs old) while pregnant with my 2nd son. Although I'm feeling ok, the "treatment" discussion has begun as my spleen is now 21cm and my CBCs aren't as pretty as they used to be. My specialist, Dr Mato at MSKCC said if interested, that I'm eligible to participate in the following study and I'm wondering if anyone out there is currently enrolled and if so, how you are doing. It's called: Phase 2 Time Limited Approach based on depth of Response to Front Line Acalabrutinib in combination with Obinutuzumab for CLL/SLL who achieve complete remission or partial remission with UMRD. Quite a mouthful!

It wasn't the only thing Dr Mato recommended, but he thought it would be a good idea and I would respond well to it. I must admit, I thought maybe I could ride this out and never need treatment, but I guess it's not the case. I really want to get my 1st treatment right, so I thought I'd post for once instead of just reading and see what advice you all have.

Thanks you

Beth

[seelel]

Hello Beth,

I have also been on a long W&W of almost 16 years (and hope it continues).

You have the favourable prognostic markers of being IgVH mutated and a 13q deletion.

Treatment options get interesting. If I were being recommended to start treatment, I think I would favour a time-limited combo to an ongoing mono therapy. So the A&O fits the bill.

With your favourable markers, I would anticipate achieving MRD negative and many years of remission.

Let's see what the others say who may have experience with this combo.

All the best for an uncomplicated journey.

[Bethro in reply to seelel]

Thanks Seelel! Happy to hear about your long w&w! It seems a bit counter-intuitive to be talking about treatments when I feel ok, but as I was told with my hemoglobin and platelets declining it's better to start the fight now than later when it may become more difficult and more complicated. Thanks again, I appreciate your input

[LeoPa]

if what they say is true and silence is golden then you are surely worth your weight in gold 😉, best of luck with your selected treatment!

[lebo222]

Hello Beth,I was diagnosed in 2011 and just completed treatment this month. Decreased plt count and bulky lymp nodes were driving force for treatment. I too have favorable markers. I have always been a more SLL presentation with low peripheral cell counts. I researched for a while. Consulted with OSU and Duke. I decided to treat locally with V+O. Although the course was a bit rocky with low ANC along the way I was able to complete time limited treatment. At conclusion of treatment cycle I am peripheral and bone marrow confirmed in complete cellular remission. Now to follow my labs and see. I was able to continue to work full time and go on with life through out treatment. All in all not too bad. Good luck in your decision making. Lots of options out there.

[Bethro in reply to lebo222]

Thanks for sharing Lebo222, Sounds like a great outcome, best of luck to you! I asked the question to the group because I see so many people treating with V&O and not A&O. Were you part of a trial or was it just what your doc prescribed?

[lebo222 in reply to Bethro]

I looked at all the options including trials and ultimately I made the decision.

[Vlaminck]

Hi, Beth, I fortunately have not yet entered treatment,but have heard of the various combinations being used, and wondering what part of the study is new? I mean, aren't some people already on A & O? What is experimental? Thanks and sorry to be asking what might be a stupid question.

[Bethro in reply to Vlaminck]

Hi Vlaminck, thanks for the reply. Def not a stupid question!! My hope when I posted was that the replies would provide some insight, advice, maybe additional questions to ask, etc. From what I understand, both A & O are approved treatments. I think the "experimental" aspect of this is the limited duration part. Participants will take the treatment for 12-24 months depending on when/if they reach umrd/mrd. Here's the link for the MSKCC website: mskcc.org/cancer-care/clini...

[Vlaminck in reply to Bethro]

Thank you Beth

[neurodervish]

Hi Beth, Congrats on making it so long without treatment! I've repeatedly read that FCR is considered the gold standard for 13q mutated folks. That said, I wouldn't wish chemo on anyone. I know the treatment landscape is evolving with new scientific breakthroughs, but I wonder if you have asked Dr. Mato his rationale for choosing A+O over FCR?

[CvilleCLLer]

Hi Beth, I am currently in this clinical trial with Dr Mato’s. I started in July and just finished my sixth Obin infusion. After six months, all of my bloodwork is in the normal range except for my platelets (119). Except for occasional mild headaches which are easily remedied with caffeine, I’ve had no side effects. I feel great. My only caution is that I’ve heard on several webinars that being on a cd 20 monoclonal antibody could put us at a higher risk of a severe response to Covid. The team at Memorial Sloan Kettering in Basking Ridge New Jersey is amazing.

Please do not hesitate to reach out to me if you have any questions.

Happy new year! Diane

[Bethro in reply to CvilleCLLer]

Hi CvilleCLLer - WOW!! This is great news, I'm so happy for you! I feel more encouraged and less dread just by reading your reply. Because I've just been sailing through for so many years it's hard to psyche myself up for entering this trial - and reading/researching about the drugs and potential side efx is probably not helping me at this point. Im also not too excited to do all the screening tests (bone marrow, CT scans, etc), but like the little post-it on my laptop says - you can't finish until you start - so I'm trying to make that my mantra! LOL.If you dont mind, Id love to keep in touch as I progress. Thanks again!!

[CvilleCLLer in reply to Bethro]

Awesome words to live by!! Yes, please do keep in touch.

Cara is an expert at doing bone marrow biopsies. It is a little uncomfortable because it’s nothing you’ve ever felt before; but I wouldn’t say painful. Im not at all anxious about the next one. 😀

[Blackdog2206 in reply to CvilleCLLer]

Awesome, I'm with you in this trial it's amazing!!!

[CvilleCLLer in reply to Blackdog2206]

Hi Blackdog!

Yes, it is an amazing trial and an amazing team. My results have been a great, too! All but platelets are back in the normal range.

It appears that I am a week or two ahead of you in the trial. I had my last Obin infusion on Dec 23rd.

It's nice to know there are others on the same journey.

Thank you for responding to my post.

~Diane

[Bethro]

Hi Neurodervish, thanks for your reply. I think FCR came up when he was talking to me about treatments because that was the go-to back when I was diagnosed in 2001. He explained how treatments have progressed and are much more targeted now - as are the pre-treatment blood tests. He said he prefers a more targeted approach for me, but I can certainly ask him to clarify when I see him next week.

[Blackdog2206]

I'm on this trial and had no side effects. Within a a week all of my numbers went to normal levels and I have a lot more energy. I just had my last obinutuzumab infusion on Monday. Our concern should be covid. The morality rates are very high for cll patients on obinutuzumab. 33-38% I believe the outcome for this treatment will be excellent with regard to our cll.

[Bethro in reply to Blackdog2206]

Thanks Blackdog2206, that's great news - I'm so happy to hear about your positive outcome thus far! I consented to the trial on Monday and will be doing my screening tests in the next couple weeks. I'd love to keep in touch and hear about how you're doing. Thanks!!

[Blackdog2206]

Sounds great! I’ll keep you posted. My visits with Dr. Mato are now 3 month intervals.