Hello folks,

I went for my four month check up today and found my white blood count was worse- has doubled in less than a year. Treatment therefore is needed soon. I have been offered a clinical trial, of Idelalisib (or placebo...) combined with Bendamustine and Rituximab. It seems like the way to go, but Iwould be grateful for any advice or opinions. I have no other symptoms other than fatigue, am 61 and a patient at UCH London.

I will endeavour to write about this for you.


13 Replies

  • I am in the same trial here in the states. I was treatment naive and 50 y/o so chemo was inevitable. I'm Hoping this combo gives me a longer remission with less toxicity than FCR. My last round of BR is this week. It certainly hasn't been a walk in the park but nothing with this disease is.

  • Hope the best for you Romarin and Justasheet1.

    I had bendumustine in 08 coming up on 7 years CR see doc next month. Main problem in the beginning upper respiratory infection and shortness of breath just after

    Chemo all has been well since. Good luck to you and

    All Cllers.

    I'm also

    In the


  • Hi Im trailing anew drug for all calling ATP 199 first week nods in my neck vanished therd week in remission I'm now on 400 mils and still clear 12 months now

  • So interested and hopeful about this new drug! Please keep posting.

  • Great to hear you are doing so well

    I think there is a typo. The drug also has a new name...

    venetoclax (ABT-199)

  • Yes its my thum to big for typing sorry the new name is a mouthful clad to hear its named now I'm still doing well and thanks for reading hope it will soon be available to everyone soon

  • Hi Romarin,

    Its good to see that you are posting on here and asking questions.

    Obviously I am sorry to hear that your blood counts are increasing -- but I hope my experience with the SAME Clinical Trial will be helpful!

    Like you, raised WBC meant that I started this Bendamustine + Rituximab + ??? phase 3 Clinical Trial in July '13 through to Dec '13 taking either CAL 101 / Idelalisib OR placebo twice a day. For each monthly treatment I posted on here - search for B + R and Idelalisib in the "Search HealthUnlocked" box above right.

    Briefly, my haematologist was very pleased (in fact delighted.) with my physical and blood test results even after a couple of months of this treatment and as the months passed by further improvements were apparent.

    Luckily, from his experience, he was able to tell that from my blood results, not just just B + R was working -- but that I must be on the Trial Drug - Idelalisib. (Which is provided to me throughout the Trial (end of 2017.) and AFTER until "it does not do me any good"

    Certainly my physical and blood results appeared to concur with a US Oncology Report dated 11/6/13 "Idelalisib produce responses in 97% with CLL" - the conclusion "I've never seen anything like this in CLL before" - the shrinkage of nodes was noticeable after a WEEK and there was a frightening increase in circulating lymphocytes --- "which reduce gradually."

    My Lymphocyte Count tripled and my nodes nearly vanished!

    My health has remained good during these last 18 months - although I am still on Watch & Wait. I have been able to restart full-time work, still maintain a garden, travel abroad, play & walk with the grandkids, decorate, etc, etc. In fact most days - I feel guilty of such good health.

    I am sure there are lot more questions you want to ask - and if I can help give my experience on my Chemo Journey in anyway - just contact me!

    May your god be with you.

    Marty (Male -- 62 - Birmingham UK)

  • Romarin, my decision to take part on the trial you have been offered is to ensure that if I end up in the placebo group, the trial will allow for "crossover" when my results indicate that the placebo group provided me with no improvement in my condition. In other words, the trial officials would allow me to move into the Idelalisib group.

    Good luck!

  • I am so grateful for these responses. Marty, I checked out your postings and feel very encouraged that the trial could go without too much pain....paperwork no problem. In fact if the number of those involved is less that 400- I feel privileged. Have always been a bit of a Pollyanna.

    Ivy- do you think this is actually possible, to be switched to the real Idelalisib? My nurse says that you do not necessarily know - well she has to say that obviously- and of course keep taking which never pill it is for 2 years after. But if there is NO improvement that would mean the B and R weren't doing anything either.....So at what point would this be decided? Surely the trial has to run for its full length?

    are you in the trial now? How is it going?

    Thanks to all!

  • Romarin, I apologize for being less than clear in my earlier mail. First of all, I am NOT in the trial you mentioned or any other at the moment. What I should have written is this: In my reading of trials and patient outcomes in those trials, usually Phase III trials, patients are usually randomly assigned to a treatment group or a placebo group. Both groups may include other drugs as well, here B and R, but usually one group gets a drug which, in combination with other drugs given to both groups (B and R), is a test drug (Idelalisib) while the other group is given the same medications (B and R) except for what I call the test drug. Instead of Idelalisib in this case a placebo is added to B and R. I think that is the trial you asked about.

    Again, from my reading, in some trials in which patients assigned to the placebo group show disease progression, they are switched to the treatment group (B, R and I) or simply offered the drugs given to those in the treatment group. I made a note a long time ago that if I were to take part in a drug trial, I would ask if the "switch" or "cross over" is part of the trial protocol.

    I hope this makes things clearer.

  • Romarin,

    Thank you - No problem - I'm just glad that my experience is of use to other CLLers!

    With regards to your nurse's comment - yes its true that a "double blind" trial means that the patient and medical staff do NOT know which group is taking the "active pill" or placebo.

    HOWEVER - the blood results (Lymphocyte Count.) and node reduction are so noticeable in such a short time it would be difficult for a Oncologist to not notice the action of Idelalisib.

    {{ The action of Idelalisib was simply described to me as "squeezing" the nodes so that the Lymphocytes are pushed into the blood stream for the B + R to attack.}}

    Hence the initial approx threefold increase in Lymphocytes in the blood. (In fact on my appointment after my first round of B +R treatment and 30 days of "pills" - my Trial Nurse panicked on seeing this "explosion" in my Lymphocyte Count.)

    With regards to "crossover".......... in the press ......

    The earlier Idelalisib Trial Study 116 was stopped early ....

    "Gilead to Stop Phase 3 Study 116 of Idelalisib in Chronic Lymphocytic Leukemia Early Because of Positive Risk-Benefit"

    BUT this meant that Gilead committed to ALL Trial Participants receiving Idelalisib - even the ones on Placebo.

    Joining the Clinical Trial includes signing a "contract" where Gilead Sciences will continue to supply me with a twice daily pill till 2017 and further if it is still giving me "benefit" and I participate in the trial "tests".

    The other advantages of being on my Clinical Trial is that I have a dedicated Trial Nurse, closer medical attention, and attendance fee!!

    If there is anything else I can help with ... do not hesitate to contact me!!!



  • Hmm. Now I am puzzled. My documentation says that Idelalisib is not approved for untreated patients in UK so no more after study finished. But then you were already treated....

  • Romarin,

    My understanding is that Idelalisib is approved by the FDA In USA & European Commission....

    "For the treatment of CLL, Zydelig has been approved for use in combination with rituximab for patients who have received at least one prior therapy; or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy."

    Our National Institute for Health Care Excellence (NICE.) is still considering the "clinical & cost effectiveness of idelalisib within its licensed indication for treating relapsed chronic lymphocytic leukaemia."

    I know its confusing !



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