Phoenix Rising tells QMUL: release the PACE trial data
Mark Berry, Acting CEO of Phoenix Rising, presents the Board of Directors’ open letter to Queen Mary University of London (QMUL) urging them to release the PACE trial data, and hopes that other non-UK organisations will join British charities in the same request...
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Status of current and past Rituximab studies

Discussion in 'Rituximab: News and Research' started by deleder2k, Jul 1, 2015.

  1. deleder2k

    deleder2k Senior Member

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    Some may have seen this before. But I think a quick summary is beneficial for new readers.

    Rituximab history

    2009


    First Rituximab study published: Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series

    2011:

    Phase 2 with double-blinded placebo-controlled study published with 30 patients: Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome. A double-blind and placebo-controlled study

    2 infusions of Rituximab two weeks apart. Significant effect from 67% in the Rituximab group and 13% in the placebo-group.

    2012:

    Study on severely sick patients:

    The study has ended and will not be published.
    My understanding is that Rituximab doesn't produce the same effect for those who suffer from severe ME.

    Source: The Biggest Chronic Fatigue Syndrome Treatment Trial ...

    2015:
    28 patients received Rituximab. No placebo-group. 6 infusions on day 0, day 14, after 3 months, 6 months, 9 months and 15 months. Data from a grant application shows a response is similar to the previous study published in 2011. 2/3 responded favorably to the drug. Many more in remission 1-2 years after final infusions compared to the last study in 2011 (61% versus 20%). Probably due to prolonged B-cell depletion (6 infusions versus 2).

    Study: B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment

    Late 2017/early 2018:

    A blinded, placebo-controlled multi-center study with 152 patients. First patients received infusions on the 27th of October 2014. Last patient is yet to receive first infusion. Looks like the study is over in July 2017. Will probably have to wait until late 2017 or early 2018 for publishing.



    Source and more information: B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study. (RituxME)


    They are also carrying out a study on cyclophosphamide after a small pilot study showed a major effect in 2/3 subjects. The study has just begun and it will probably be finished before the phase 3 Rituximab study due to the early reponse rate compared to B-cell depletion.


    These are the ones to thank:
    [​IMG]
    dr. Olav Mella, study coordinator Kari Sørland, and dr. Øystein Fluge (Photo by the Kavli foundation)
     
    Last edited: Jul 1, 2015
  2. Bob

    Bob

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    There seems to be a bit of info about this here (note that the outcomes discussed are in relation to very severely affected patients):
    http://forums.phoenixrising.me/inde...aintenance-treatment.38477/page-2#post-613781
     
    barbc56 and catly like this.
  3. deleder2k

    deleder2k Senior Member

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    Thanks @Bob, I will add that to the post.
     
    Bob likes this.
  4. Sidereal

    Sidereal Senior Member

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    Why is the pilot study showing nonresponse in very severely and severely affected ME patients not going to be published? These findings are of major clinical interest.
     
  5. deleder2k

    deleder2k Senior Member

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    I don't know. I don't think they completed the study. I guess there is nothing to publish. I think they have mentioned their findings in the latest published paper.

    If part A of the cyclophosphamide trial is positive, they will do a study on severely sick patients (completely bedridden).
     
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  6. alex3619

    alex3619 Senior Member

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    Do we actually know they do not respond? What is implied here is that they don't respond as well as less severe patient responders.

    The phase 3 trial may well address this. I hope it does.
     
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  7. alex3619

    alex3619 Senior Member

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    This kind of study is needed on all treatments for ME and CFS. Sadly it often has not happened in the past.
     
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  8. deleder2k

    deleder2k Senior Member

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    Absolutely. It is very difficult to do though. I think the plan is to infuse cyclo where patients live. They would need a doctor, a nurse, equipment at each patients home. It is very costly and time consuming.
     
  9. deleder2k

    deleder2k Senior Member

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    That is correct. The first impression is that they respond less favorably in general.
     
    SOC likes this.
  10. Martial

    Martial Senior Member

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    very interesting, is this something currently being offered on the market? Or clinical trials for an unreleased pharmaceutical.
     
  11. alex3619

    alex3619 Senior Member

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    Rituximab is an established and available treatment for rheumatoid arthritis, lymphoma, and I think other diseases. The phase 3 trial which will give a strong basis to it being an effective treatment is due to be completed in 2017.
     
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  12. alex3619

    alex3619 Senior Member

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    Yes, and ME and CFS have been massively underfunded. The lack of funding has meant these studies have not happened, all too often. Only a very few have done such studies, though the mindset is changing and such studies are now becoming considered as mandatory.
     
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  13. Folk

    Folk Senior Member

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    Amazing work.
    That kind of post helps so much to organize all this stuff in my head.

    Thank you
     
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  14. msf

    msf Senior Member

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    Wouldn't publishing the severe ME study potentially be just as informative as any of the other studies?
     
  15. Sidereal

    Sidereal Senior Member

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    Yes, I posted the excerpt on the other thread. Even though the study wasn't completed, they seem to have treated 4 severe/very severe ME patients with RTX as part of that study. They could publish it as a case series just as they did the original 3 cancer patients with ME. Negative results are just as important as positive results in helping clinicians and patients make informed decisions about treatment.
     
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  16. Bob

    Bob

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    I think it's important to note that the four patients that are discussed in the excerpt, in terms of their response to treatment, were very severe patients only. It doesn't mention how the four severe patients responded. As far as I understand it.
     
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  17. deleder2k

    deleder2k Senior Member

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    It has come to my attention that the study on the severely sick with Rituximab has not ended. To my understanding they are in the progress of doing it. I can't edit my first point. I am sorry for the misinformation.
     
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  18. greeneagledown

    greeneagledown Senior Member

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    @deleder2k, do you know if they've filled up the phase 3 Rituximab study yet, or are they still recruiting? The clinicaltrials.gov page for the study hasn't been updated since December.
     
  19. deleder2k

    deleder2k Senior Member

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    There has been some delay at the University Hospital of North Norway. From what I've heard they are still not done. I have heard early autumn. They will probably get the last patients going after the summer break is over.
     
  20. greeneagledown

    greeneagledown Senior Member

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    Thanks for the update!
     

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