Venetoclax, acalabrutnib, obitunzimab

[Tton46]

Good morning all! Hope you are all doing well today. I’ve been reading a lot, but not posted much, so hear it goes! I have b en struggling with fatigue for years, I will not go through all the details of the past 6 years, but it’s been a ride, I only found out last year I have Cll, 11q del (although 5 years ago I told a couple docs I thought I had Leukemia, my bloodwork at the time simply did not justify it or a reason for bone marrow biopsy which I was wanting!)

My fatigue and body aches, bone pain are all getting so bad I just feel like I constantly need sleep or rest, I have my adderall for days I really need to get stuff done, but hate to take it. I’m trying to hold out for clinical trial ... acalabrutinib, venetoclax, and obitunzimab it was supposed see you be open for enrollment in March then covid hit. I’ve been checking MD ANDERSONS site daily to see if it it available. Still not, on a side note they just started opening up trials again, so hopefully i will see it pop up on there soon!

Are any of you on this trial, and if so how is it going? I know I have seen it active in other states and I could enroll now in Boston, but I would prefer to travel to M.D Anderson

[Hidden]

lily_pad_master is on it.

[Tton46 in reply to Hidden]

Thank you!

[Canuck901]

Aussie Neil is on it , so ydarney is on the A plus V arm and so are a

few others

It’d called the ACE 311 trial

[Tton46 in reply to Canuck901]

Thank you! I’ve just seen it named the AVO trial!

[Hidden]

This one? clinicaltrials.gov/ct2/show...

Locations: clinicaltrials.gov/ct2/show...

Seems to me Dana Farber would be a good connection?

I'd keep in mind that travel is a COVID risk.

[HikerBiker in reply to Hidden]

The trial at Dana Farber is only open to those with Del(17p) or

TP53 mutation. I had been hoping to get on this trial as well as I'm in the area.

[Hidden in reply to HikerBiker]

Thanks. Copy that... I missed that inclusion criteria.

[Tton46 in reply to HikerBiker]

Oh I thought it was 11q as well since it is high risk?

[Hidden in reply to Tton46]

I am 11q unmutated. My CLL specialist categorized me a moderate risk prognosis, better odds than 17p TP53.

And this is a bit dated criteria, need comprehensive longer term data, but still a bit anachronistically based on FCR,

With BTK, BCL2 and MAB, less of an issue.

[Lily_Pad_Master in reply to HikerBiker]

When did that change? Are you certain? I’m in the Dana-Farber AVO trial, Cohort 1, 1st to sign, 3rd to start, I believe. I’m unmutated. That’s all. And I work there. Haven’t heard that. Always glad to be wrong, though...means I’ve learned something new.

[Tton46 in reply to Lily_Pad_Master]

Yes, I believe the second Cohort is just 17p tp53 as it is the highest risk!

[Lily_Pad_Master in reply to Tton46]

Well, it's a good day today. I learned something!

[Tton46 in reply to Lily_Pad_Master]

I could be wrong... that’s just what I remember reading as I was considering Boston if MDA doesn’t get started before I have to have treatment!

[Lily_Pad_Master in reply to Tton46]

Boston's awesome and, yes, it seems it would be quite a trip for you, particularly during the Obinutuzumab infusions.

[schmitthj007]

I have been on this trial for about 19 cycles now participating in Boston. Dana faber is a great center and I feel well taken care off. See my profile for more details.

It is a great trail but I had ups and downs with serious side effects which could be partly caused by my CLL. I am in complete remission likely after cycle 12 but had to stop all medications after cycle 17 due to pancytopenia. Continue to have neutropenia thrombocytopenia and low grade hemolytic anemia after being off all medication now for 2 months. Had to stop venetoclax in during the trial due to neutropenia but continued on 300 mg until stopped completely. Intention was to take acalabrutinib and venetoclax until cycle 24.

Overall feeling great without major infection or bleeding complications. Work full time many hours and did not have to stop except for treatment and of course venetoclax load for 3 days each dose increase.

I feel blessed having had the chance to participate but may have underestimated the complication risks a bit. It is a long trial compared to FCR for which I would have been a candidate as well. Would I do it again? Absolutely. The team at Dana is truly outstanding and I am sure the same is true for MD Anderson. I hope you can get in and start soon to feel better. My debilitating fatigue improved within 2-4 weeks.

[Canuck901 in reply to schmitthj007]

Excellent , too bad it’s only available at Dana farber, and not in Canada

[Hidden in reply to Canuck901]

don't they have drug trials in Canada?

[Canuck901 in reply to Hidden]

Not many the US seems to get the majorly of them

[Hidden in reply to Canuck901]

uk seems to.

[Tton46 in reply to schmitthj007]

Thank you so much! Prayers for you! I pray for healing for you! I am unmutated 11q 47 yo are you 11q or 17p?

[schmitthj007 in reply to Tton46]

Thank you Tton. I am actually 13q and am mutated.

[Yidarmy69]

Hi I’m in U.K. I’m on A + V it has worked really well for me no side effects at all bloods normal noades normal my consultant said I am in remission after 6 cycles just waiting for BMB good luck hope you get on trial in U.K. trial is called Ace 311

[4Glory]

Hi, Tton46! Ask your doc. Mine said I could be in a trial if I wanted to even though it says they're all suspended due to COVID. Let us know!!! 😊

[Tton46 in reply to 4Glory]

Talked to Doc and trials are starting back up!! This one will most likely be 2-3 months from now! Hope I can wait it out!

[Sojomama13]

Hi,

I am on AVO phase II Clinical trial at Dana Farber, I am TP53 and 17p deletion. Doing very well, fully ramped up on the Venetoclax and after today, I have two more Obinutuzumab infusions. I will be restaged sometime in July/August. I was not a candidate for chemo due to my markers. I was happy that this trial was open for me due to the fact that I have a family history of Afib, I was concerned about taking Ibrutrinib.

Wishing you all the best,

Sandy

[Canuck901 in reply to Sojomama13]

Mutated or unmutated? Excellent Hoping you have a lengthy remission.

[Lily_Pad_Master in reply to Sojomama13]

Hi Sandy. I have one month left in this trial! If MRD becomes the revised outcome measure, I will have been CR since month 7! Love the Farber and Dr. Davids, Josie, Victoria, infusion nurses. Everyone is so kind and brilliant.

[Sojomama13 in reply to Lily_Pad_Master]

I could not agree with you more. I have had the best experience with those same folks, adding in Dr. Jennifer Brown. I am so grateful that, like you, I have an experienced and knowledgeable team. Early on the best advice I got was to get a CLL Specialist, I am convinced that has made all the difference for me. I wish you all the best.

Sandy

[Lily_Pad_Master in reply to Sojomama13]

I know that no matter what happens, I am held blameless. Why? I sought out the best (and there are “bests” all around the country). An error in my genetics might do me in, but not in my decision making.

I wanted Dr. Brown when I became a patient in 2013. Dr. Davids walked in and I was like, “Oh, man. I got Dougie Howser!” Well, Dougie was pretty brilliant, too.

[HikerBiker in reply to Sojomama13]

Hi Sandy,

How did your ramp up on Venetoclax go? I am due to start V on Tuesday. Dr. Brown is my doc too. Dana Farber is a great center - my infusion nurse even picked up on the fact my reticulocytes were low and I was experiencing hemolytic anemia. Very lucky to be close to a place like D.F.

Rick

[Sojomama13 in reply to HikerBiker]

Hey Rick,

The only issue that I had on the Venetoclax was that hemolysis of my bloodwork. I am not certain, nor were they, that it had anything to do with the Venetoclax. I have super tiny veins , so they were unable to use a very, very slightly thicker needle. I had to have multiple sticks. Dr. Brown is incredibly thorough and very cautious. Finally they tried having one nurse draw and the other pull off the band and immediately put the sample on ice.

They advised me to take the Venetoclax with a fatty snack and a full belly. While you are ramping up, you sort of have to follow their schedule. I found that I was very bloated and gassy. (Yep) Now that I am on my full dosage, I take it between lunch and dinner. This works best for me. Those side effects are nearly gone. I chose to slowly move up my time to find the best time for me. They warn about tumor lysis during ramp up. I had a scan and was told that I was at low risk. Also, I believe the order of drug administration helps lower the risk. Acalabrutinib then Obinutuzumab help shrink your nodes quite significantly, at least that is what happened with me.

Rick, sorry for the lengthy response. I wish you all the best. I have my last infusion mid July. Whoot Whoot!!! I’m doing awesome. My numbers look great and best part is that I am feeling AMAZING!!! I have been whooping my kids butts at pickle ball and I feel better than my old self.

Best,

Sandy

[bhayes84]

Why do you need to wait for a trial? Acalabrutinib and Venetoclax were both approved for first line treatment of CLL.

[Canuck901 in reply to bhayes84]

The acalabrutnib and Venetoclax combo ? Really what countries ? Not in Canada

[bhayes84 in reply to Canuck901]

Oh, sorry, I assumed you were in the U.S. when you mentioned Boston. I guess you could get it prescribed my a U.S. doctor (?) but Canadian insurance probably won't cover it.

I assume Ibrutinib has the same issue.

Good luck. I hope you find a way to get these soon.

[Canuck901 in reply to bhayes84]

So insurance in the USA would approve the combo acalabrutnib and Venetoclax?

I thought those are only for trials

In Canada acalabrutnib , Venetoclax are approved for monotherapy only

Not combo yet

Hope that changes very soon

[bhayes84 in reply to Canuck901]

As you mentioned in the US the monotherapies are covered - I don't know about the combo. It seems like from user comments here that usually Ibrutinib or Acalabrutinib is tried first and then if those fail they move on to Venetoclax + Obinutuzumab which leads to MRD than other CLL treatments.

If you're able to get Acala (which I'm on) or Venetoclax separately I don't why your doctor would wait on getting the combo. Many patients have done quite well on Ibru/Acala. (Maybe I misunderstand your particular situation.)

[Tton46 in reply to bhayes84]

I am in USA

[Tton46 in reply to Canuck901]

Acalabrutnib not approved here yet outside of trial! OKC, Ok USA 🇺🇸

[AussieNeil Partner Administrator in reply to Tton46]

Acalabrutinib was approved for the treatment of CLL in the USA in November 2019: astrazeneca.com/media-centr...

[avzuclav in reply to Tton46]

Also if you have private insurance in the USA, you're likely to have a $0 copay.

calquence.com/patient/suppo...

[SERVrider]

I have a telephone consulttion with my haematologist on 4th June and hope she has been able to get clearance for me to have acalabrutinib as a monotherapy. NICE haven't yet authorised it for general use in the UK and there is no marketing approval for it either in UK or EU, though Sweden has approved its use. If clearance is denied, then it is back to Plan A of obinutuzumab and chlorambucil

[JimboW]

I wish the best for you! Medicine has come a long way in regard to CLL. While I only know enough to be dangerous I can tell you the Gazyva worked wonders for me. My Oncologist has been superb and I am nothing if not grateful for him and his staff. I am much older than you so my treatments are probably different from what you have or will receive, but hang in there! There is a brighter day ahead!!

[Tton46 in reply to JimboW]

Thank u!

[Tton46 in reply to JimboW]

I will be on acalabrutnib venetoclax and obitunzimab

[Tton46 in reply to Tton46]

Hopefully if I can hold out

[JimboW in reply to Tton46]

You will! If not you than who?

[Sojomama13 in reply to Tton46]

I am on it and thrilled with the results.

[Canuck901 in reply to Tton46]

That’s a great trial I hope you can get on it