Hi everyone , how far do you think we are away from not using FCR has the first line treatment , and drugs such as ibrutinib or cal - 101

[stewie]

I know some ibrutinib trials has began in the uk also consultants going through NICE to make this drug available to some patients

Stewie

Watch and wait

Student nurse

[Cllcanada Top Poster CURE Hero]

No UK open trials yet ..that I'm aware of...

FCR will be the standard of care for the the next 5 years probably longer...unless something comes along with the general criteria...

1. extend overall survival

2. maintain current survival but lower costs

3. maintain current survival with reduced side effects

They need Phase III long data from a number of trials, it depends how long they take to accrue. Then the data, likely 3 years but generally 4 years...will be used from several trials.

FDA and EU approval...takes about 18 months, fast tracked... then there is the issue on nonconventional trial endpoints, like CR, these new treatments don't fit well. How flexible these agencies are to basic change remains to be seen. Certainly in the past change never happened and drugs like Genisense a CLL BCL-2 inhibitor died in the review process, for various reasons, some due to lack of company funding.

But, the big hurdle going forward will funding and cost, these are extremely expensive treatments, how social medical systems like NICE and Canada, Australia etc will attempt

to fund these is unknown. Likely will be used on a few 17p/TP53 high risk patients and perhaps end stage relapsed refractory inlieu of HSCT...atleast initially, until an economy of scale kicks in...

Current data actually indicates they don't work well for everyone as mono therapy, so look to them being used in combination with things like bendamustine or perhaps monoclonal antibodies, like obintuzumab etc

This is the timeline I see based on 15 years of studying CLL and the drug approval process, hope it is a faster time line, but I doubt it. People point to Gleevec...that was a one off, and these treatments, so far, aren't even close to Gleevec in its effacacy.

Case in point..I have spent the last year advocating for the use and funding of bendamustine first and second line in CLL in Canada... the recommendations have failed for relasped/ refractory CLL, 'the committee was not confident of the net clinical benefit of bendamustine in RR disease' This makes Canada the only deleloped country in the world to take this viewpoint and fail approval... unconscionable.

pcodr.ca/idc/groups/pcodr/d...

So you never really know...when dealing with the vagaries of approval bodies.

~chris

[Mikey47]

Stewie.

From UK Clinical Trials Gateway:

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Both open and currently recruiting (both for Relapsed or Refractory patients).

[HAIRBEAR_UK Founder Admin]

Good thoughts Chris, I guess what happens with the FDA will give us our first indications? gutted to hear about bendamustine in Canada.

There is only one UK trial I know of in development for "Go Go";CLLs

CLL 10, Phase II/III randomised trial to assess the efficacy and safety of Ibrutinib in combination with Rituximab (Ibrutinib+R) compared to Fludarabine, Cyclophosphamide and Rituximab (FCR). .IT WILL BE RANDOMISED SO MAY NOT PROVIDE AN ALTERNATIVE

The trial was planned to open in 2013 to replace ADMIRE and ARCTIC

After ibrutinib +R has been assessed in a phase II setting to determine whether the response, MRD and safety in the ibrutinib+R arm is acceptable it will continue to the phase III setting which will compare FCR with the novel drug Ibrutinib + R.

I don't know how it is progressing , but perhaps we can get more information at the end of the month from Cardiff.

Listening to the clinical researchers at the CLL Forum in October it was going to committee for approval and was suggested may be available in the 3rd quarter of this year.

cllsupport.org.uk/news_arch...

Very early days, as Chris says many hurdles to overcome.

Nick

[littleriver]

Thank you.How do we make contact with the people concerned with the trials?

[jangreen]

Hi Having been on the admire trial (I start treatment Oct 2010 finished March 2011)I would hope that these new treatments come on line just when I need them. Lets hope for good results in what we hope will be a new era.

[Cllcanada Top Poster CURE Hero]

These 2 trials are for relapsed refractory CLL/SLL patients in the UK....just because it says they are recruiting or a hospital is listed means nothing...check with the actual facility.

clinicaltrials.gov/ct2/show...

clinicaltrials.gov/ct2/show...

See locations link...on these pages...

[Cllcanada Top Poster CURE Hero]

jangreen.... I don't see this as a new era, but an incremental advance... like rituxan and all medicine with rare exceptions, and I feel ibrutinib will be added to current treatments, just like rituxan was. In this case ibrutinib will clear the nodes, and kick the malignant cells to the blood, where monoclonals and chemo will clobber them.

Look for treatments like FCRi, BRi, rituxan + i etc... for the next 5 to 10 years...

Currently the hype is ibrutinib, the answer is still in a lab somewhere... just my view, guess we will know in 4 or 5 years.

[bkoffman CLL CURE Hero]

I am more optimistic and see these new meds as game changers, but as Chris said, they are the final story. That is still in the lab. However, I believe that these new biologicals such as ibrubinib and GS1101 will mark a major move away from chemo such as FCR and BR as first line therapy. In the USA, I suspect we will see a significant shift in 3 years

[andrewschorr]

Maybe for 17p deleted patients or those where test show chemo wouldn't work. But otherwise it may be a long time. Studies are underway but with the expense of the drug it will have to be a home run I think. We'll see.

[taraa in reply to andrewschorr]

Has anyone had the injection of Neulastim sc this was given after my 5th month chemo of FC [no R] the end of December. It hasn't done anything for me I am an elderly patient first diagnosed March 2004. Just wondering. Thanks taraa.