Clinical trial of GS-1101(also known as Idelalisib)

Hi, I've recently enrolled into a clinical study, A phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy of Idelalisib in combination with Bendamustine and Rituximab, for previously treated CLL, is there anyone on here who is on the same trial and can let me know how they are doing, or have heard about this trial, I'm due to start it in the next couple of weeks, as I have been in remission after FCR for 2 years, but it has returned aggressively over the last few months, my lymph nodes in my neck are growing at an alarming rate.. I now look like He-man !!! ... If Anyone has any info, would be great to hear from you ... Thanks

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  • Is this the trial you are referring too?

    clinicaltrials.gov/ct2/show...

  • Yes!!! Do you know anything about it ? .. Thanks for site .. X

  • Hi Janet,

    I'm on a similar study with Idelalisib & Rituxan, that got fantastic results reaching the end point last September one year ahead of schedule, so the primary double blind phase was ended and everyone was put on the active drug.

    When you start taking Idelalisib, your nodes will likely begin shrinking in the first week, and be noticeably smaller within one month.

    Idelalisib will probably be approved by the FDA in the next 6 months, and your trial may reach an end point soon and convert to all on the active drug, so there are very few reasons not to expect wonderful results.

    You may have some gastro intestinal reactions in the first 12 weeks, but most people acclimate to the drug if those occur. The consent forms you signed or will sign, list many complications, but only about 15% of the patients on my trial had strong side effects and nearly all were reversible.

    Good Luck & welcome to the Idelalisib Club, we are all having a great time here!

  • The trail Len referenced just published... unfortunately it is behind a paywall nejm.org/doi/full/10.1056/N...

  • Janet,

    I joined this clinical trial in July 2013 - after two & half years relapse from an FCR treatment - so similar to you!

    I posted every month of the six cycles of B + R - on here.

    Briefly I tolerated this treatment well - which includes taking Idelalisib or placebo twice a day. - and now until 2017 or longer

    Whilst it is a double blind trial - after the first cycle of treatment my blood results gave such obvious positive indications that I was taking Idelalisib.

    (My lymophocite count tripled.)

    Early in Jan 14 I had an "after" CT scan and bone marrow biopsy which confirmed that my CLL was significantly reduced from the "before" tests.

    Being on the trial means that you are more closely monitored than normal - and some times the it seems that the trial needs an "armful" of blood samples - but on the whole it is not too arduous.

    Even the two days of B+ R. Chemotherapy each month, whilst 4-5 hours I was able to drive myself to and from the day care unit !

    The positive with the trial is that I had my car parking and reasonable expenses paid as well as a daily attendance allowance!

    If you can read my "monthly posts" they may help to understand my treatment journey - or if not - ask me anything further you have concerns about!!!!

    If not I hope your treatment goes well !!!

    Regards

    Marty - < male 61 / Birmingham UK

  • Thank you for your emails and I'm sorry for my late reply, unfortunately at the last minute i was unable to start the trial due to my biopsy report, my CLL has transformed into diffuse B cell lymphoma so I have now started a course of R-Chop chemo with a view to getting me in remission and then stem cell .... Taking each day as it comes at the moment, but very positive and still smiling !!! .... With best wishes for the future, take care Jan x

  • Sending you massive best wishes Janet and so sorry you weren't able to start the trial. Sincerely hoping for a successful remission and you must keep that smile going, it's bright enough to light up a room!

    Warm regards,

    Newdawn

  • So sorry to hear that, Janet. But I'm glad to hear you're still smiling and feeling positive. Do let us know how you get on with the R-CHOP.

    Wishing you all the best,

    Paula

  • dear janet--hope your dlbcl transformation is one of the more fortunate 20% that's clonally unrelated to the original cll. failing that, hope you get a sufficient response to the r-chop to go for the autologous stem cell transplant. best regards jerry mc

  • Far too many Richter's patients... you are the third in the past two weeks that I'm aware of...Janet.

    RCHOP was extremely hard on me, watch for shingles and any weird stuff call the oncologist on duty at your treatment centre...immediately.

    The orange pee is normal... but nobody told me about it! ;-)

  • Starting it next week in Sydney, Australia. Very excited (and very nervous and very lumpy). I'll report.

    Val

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