Ace -311-CL-311 UK

[Yidarmy69]

Hi I’ve just been randomised on Ace trial 311 and have been given arm A which constantly of Acalabrutinib 100mg daily then Venetoclax starting on 20mg on cycle 3 for 1 week then 50mg for a week then 100mg then 200mg then 400mg daily I’m in uk really excited but also very nervous as this is my first treatment for CLL

[Justasheet1]

I never heard of this trial before.

[Yidarmy69 in reply to Justasheet1]

Hi it’s a brand new trial in uk I think it has been trialed in US but with Obinutuzumab added

[Jm954 Administrator]

Sounds excellent - hope it goes well for you!

[Yidarmy69 in reply to Jm954]

Thank you will keep everyone informed about it

[Newdawn Administrator]

This sounds like an excellent trial. I’d have certainly opted for Acalabrutinib over Ibrutinib so great outcome!

Newdawn

[Yidarmy69 in reply to Newdawn]

Thank you I will keep you and everyone updated

[Canuck901]

Good luck sounds like a good trial. They have had extremely good results from these combination therapies

[Yidarmy69 in reply to Canuck901]

Thank you very much will keep everyone informed

[AussieNeil Partner Administrator]

The full study title is Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

It's a randomised, multicenter, (19 countries!) open-label, Phase 3 study to compare the efficiency and safety of Acalabrutinib compared to the investigator's choice of chemoimmunotherapy (BR or FRC) in subjects with previously untreated CLL without del(17p) or TP53 mutation. AstraZeneca are running the trial.

If you are taking a Proton Pump Inhibitor, (Omeprazole/losec, etc), you'll have to find another way to control your GERD. The other exclusion criteria that could be an issue is if you have significant cardiovascular disease or require an anti-coagulant. See clinicaltrials.gov/ct2/show... for full details

I have a pre-assessment appoint next Tuesday for this trial, but I may not meet the neutrophil and platelet count acceptance criteria.

Neil

[Jackpot in reply to AussieNeil]

I am in the same clinical trial. The Acerta trial. I was randomized to arm A, acalabrutinib for the first two months and then venetoclax added in cycle three. I have started venetoclax and am currently on 50 mg. I will move up to 100 mg next week.

My platelets were 42 when I started treatment. On Monday, blood tests indicated that they had risen to 141. These drugs work quickly!

I really hope you are accepted into the trial, Neil and I hope you get the arm that you want.

Best of luck.

Cindy

Canada

[AussieNeil Partner Administrator in reply to Jackpot]

Thanks Cindy, you've given me much needed hope, given my platelets are not much higher than yours were when you started. It's definitely time that my bone marrow had a good Spring Clean!

[AdrianUK in reply to AussieNeil]

I hope you get into this very excellent sounding trial. I hope that they will open some more UK sites especially as FLAIR will presumably soon be closing to enrolment. Clinical trials . Gov only has one Uk site at the moment Canterbury. But perhaps they will expand. There is always a balance between opening too many centres that you worry about the study being conducted in the same way at each centre and opening enough that you can enroll the population quickly which is in everyone’s interest (provided that it’s the right group of people enrolled!)

[Yidarmy69 in reply to AdrianUK]

Hi Adrian thank you I started on this trial yesterday Ian lucky to be no1 on it my consultant at Margate it’s only 16 miles away from Canterbury Dr Young is running this trial so I suppose I was lucky to be in right place at right time they have been excellent from the moment I gave blood which were then sent to Geneva and New Jersey. Then randomised to arm A luckily for me I will keep you updated on my progress I will ask if trial will expand

[Yidarmy69 in reply to Jackpot]

I started this trial today taken my Acalabrutinib twice today very excited have you had many side effects ?

[Jackpot]

I had small red dots that were noticeable on my legs but they disappeared after a few days. This went on for the first cycle. I have had some odd muscle “ pain” but not too bad at all. After about two weeks I did start to get heartburn. Probably due to the stress of starting treatment, not sure. Dr said it could be a side effect for me though it is not listed as one. It continues to come and go but I am still able to do all of the things I want to do - daily brisk walks, painting class, seeing friends, etc.

My spleen was enlarged and after only a few days of acalabrutinib, the discomfort I was experiencing was gone. And the lymph nodes in my neck, etc. really did start to go down quickly. It is amazing stuff!

I find it difficult to drink at least two litres of water every day. I was not used to drinking THAT much water before starting treatment. But I have a pretty good system for keeping track so I make sure I get enough.

I was also excited and nervous at the same time when I started treatment..When I swallowed my first pill, I said to my husband that not only was it a pill, it was hope.

You will do well. Keep in touch and let me know how you are doing.

Cindy

[Yidarmy69 in reply to Jackpot]

Thank you for your kind and reassuring words like you said it’s a massive step for us all I am grateful to be on this trial it’s the only one in England and I only live 16 miles away 40 minutes by car so travel isn’t a problem I will update you at regular intervals

[Fran57]

Wishing you lots of luck for this treatment.

My husband has had FCR(about 4 years ago ) and has been told he will need more treatment in the not too distant future... so it’s always good to hear of any treatments that are becoming available in the UK.

I’m looking forward to hearing about your success!

Fran 😉

[Yidarmy69]

Thank you trial is in Canterbury in Kent only at the moment hopefully it will expand to other hospitals in uk I will post regularly on here cheers

[Canuck901]

Are you taking 100mg once a day or twice a day of acalabrutnib? I thought Full dose is 100mg twice a day.

Thanks

[Yidarmy69 in reply to Canuck901]

Hello 100mg twice a day and 400mg venetaclax in the morning