STATIC now beginning to open at sites in the UK

[Jm954]

The long awaited successor to FLAIR for patients randomised to one of the Ibrutinib arms is finally ready to open at sites in the UK.

When each site is ready will be up to local researchers and resource availability but the trial will be conducted in 100 NHS Centres in the UK (England, Wales, Scotland and Northern Ireland), the majority of which are already participating in the FLAIR trial.  

STATIC is designed with multiple pathways, the ‘Randomisation Pathway’ and the ‘Clinical Need Cohort or Group’. The route a participant enters will be determined by their eligibility. 

The primary objective is to assess non-inferiority (NI) of the intermittent treatment strategy in terms of time to treatment strategy failure, defined as the first documented instance of active disease (as defined by the 2018 iwCLL criteria) that does not respond to treatment, or death. 

Randomisation Trial: A prospective, national, multicentre, open-label, randomised, controlled, 2-arm, parallel-group, non-inferiority, phase III trial to assess whether patients with CLL on long-term treatment with a BTK inhibitor, (including ibrutinib) have similar disease control with an intermittent treatment strategy (experimental arm) compared with standard continuous treatment (control arm). 

Clinical Need Cohort: A prospective, national, multicentre, open-label, single-arm, non-randomised cohort to assess the overall safety and survival of patients with CLL receiving long term, continuous treatment with Ibrutinib

The trial will be conducted in 100 NHS Centres in the UK (England, Wales, Scotland and Northern Ireland), the majority of which are already participating in the FLAIR trial.  

As of 24th November one site is open to recruitment, Royal Cornwall Hospitals NHS Trust, there are 35 sites in set-up and a further 26 hospitals have been selected and will begin site set-up when they are in a position to do so.

 800 participants will be recruited into the Randomisation Trial; 360 participants will be recruited from ibrutinib based arms of the FLAIR trial, and 440 participants will be relapsed refractory patients who have been treated in second or subsequent line of therapy with ibrutinib.  

Participants recruited into the Clinical Need Cohort, will have received ibrutinib treatment in the FLAIR trial. It is anticipated that approximately 30 participants will enter this cohort.  

In order to reach the required 800 participants in the Randomisation Pathway the trial will recruit for a total of 6 years. Currently no participants have been recruited; potential participants have been approached, and if these participants choose to join STATIC they will consent at their planned routine appointments.

[cartwheels]

Did consider this myself as I'm coming to 6 years on ibrutinib and still in remission ,but my consultant is not keen of course he said it's my choice but got the feeling as he put it , you are doing well , tolerate the drug well why risk change. And when he put it like that I sort of have to agree . But well done and thanks for all those who do take up the trial

[Jm954 Administrator in reply to cartwheels]

I would agree with him, if your side effects are tolerable and you’re doing well, I wouldn’t change.

[Eucalyptus22]

Interesting. Is this just for people on Ibrutinib or does it include those on Acalabrutinib?

[Jm954 Administrator in reply to Eucalyptus22]

at the moment, just Ibrutinib.

[KrisBren01]

Hi jm954, I was on the flair trial for 6 years finished 22 months ago and have relapsed about 4 months ago. Back on watch and wait for now but numbers are creeping up. I'm at hospital tomorrow, I was wondering if now I've relapsed if I would no longer be eligible for the Static Trial? Consultant said I would be as I've been on the Flair trial but that was before I relapsed. I can't tell from reading the information. Thank you Sue

[Jm954 Administrator in reply to KrisBren01]

I’m on holiday in Yorkshire at the moment and don’t have access to all my notes but I think you can enter and you would be in the Clinical Need group that would be put back on Ibrutinib

A bit more here

images.cllsupport.org.uk/ht...

and here

isrctn.com/ISRCTN51675454

Jackie

[KrisBren01 in reply to Jm954]

Thank you Jackie, I'm going to speak to the consultant tomorrow when I go to see him. Will let you know what he says. Thanks again. Enjoy your holiday. xxx

[bennevisplace]

Jackie, could you please clarify: for those in the Ibrutinib arm of the FLAIR trial, is STATIC their only option of continuing treatment beyond 6 years?

[Jm954 Administrator in reply to bennevisplace]

yes, I’m afraid so

[fapumpkin in reply to bennevisplace]

I received the Static information a while back, (been pestering my haematology department for over a year).

The following is from "STATIC intermittent vs. continues treatment strategies in CLL."

page 3 of 41 ;

"To find out which way of using ibrutinib is best we need 800 patients to take part in the STATIC Randomised trial. Patients who take part will be those who have finished FLAIR and those who have been teated on the NHS with ibrutinib as their second or subsequent treatment for their CLL.

We anticipate that a small number of patients finishing FLAIR will be advised to continue ibrutinib as their CLL is not well controlled enough for them to take part in the randomised trial. They can continue ibrutinib in STATIC. This part of the study is called the 'Clinical need group', information from this group will help us understand more about the long-term benefits and hazards of ibrutinib."

Page 4 of 41:

"There are two groups in the STATIC randomised trial with two different ibrutinib schedules:

Pausing ibrutinib: Take a break from ibrutinib and only restart if your CLL gets worse again, if restarting ibrutinib controls your CLL again, you will be able to take another break from it.

Continous ibrutinib: Continue to take ibrutinib every day. You will continue ibrutinib without a break as long as you are benefitting from it."

Hope this helps.

I have been treated via the Flair rituximab/ibrutinib arm, my ibrutinib treatment finished back in June. I am opting to be part of STATIC