• Cancer Research Study-ME-401

    Asked by kdavis11259 on Sunday, February 17, 2019

    Cancer Research Study-ME-401

    I have follicular lymphoma diagnosed in 2013. I have been treated for it twice, and was only in remission for about a year both times. Now I am considering, and am currently beginning the process of screening to participate in the cancer research study for the experimental drug ME-401 in the treatment of relapsed/refractory CLL/SLL and follicular lymphoma. ME-401 blocks a molecule called P13K delta which is present in normal lymphocytes and lymphoma cells. P13K's are a family of enzymes that are often over expressed and have been shown to play a critical role in the proliferation and survival of certain cancer cells. I was wondering if there are any other people who have taken this drug, or who have participated in this study, and if so, what has been your experience? Thank you.

    6 Answers from the Community

    6 answers
    • GregP_WN's Avatar
      GregP_WN

      I have not, but I wish you all the best in your trial. We hope it has great success.

      8 months ago
    • po18guy's Avatar
      po18guy

      I see that this is a brand brand new drug. Is this the sturdy you are entering?

      https://www.clinicaltrials.gov/ct2/show/NCT03768505?term=ME-401&recrs=ab&rank=1

      This particular study was only listed on December 7th, 2018. I do not know if they ever filled their expected cohort of 133 patients in the phase 1 study, but those few worldwide would be the only persons with any experience.

      I found this out when I entered my first trial. I asked my hematologist about the long-term effects of the drug. He smiled and laughed and said, "You'll tell us!" one possible source of information may be to look up other PI3K inhibitor class drugs (both approved and in later phase trials) and examine the associated side effects.This will not provide a precise answer, but may offer some general guidance on what to expect. Here is one possible source:

      https://www.drugs.com/drug-class/pi3k-inhibitors.html

      As a rule, the inhibitor class drugs have a milder side effect profile than virtually all classic cancer therapies. I was on the first biologic drug for 5 years and while it was a quite different drug (HDAC inhibitor), and had some reasonably serious short term, post-infusion effects, there were zero discernible long-term effects. The other inhibitor class drugs I tried (a second HDAC inhibitor, an Aurora A Kinase inhibitor, and a Rho-associated coiled coil 2 Kinase inhibitor [ROCK2]) all had fairly mild side effect profiles and were well tolerated in my case - just not effective.

      If you are at a center which conducted the phase 1/1b study, you might put in a call or send an email to the lead investigator to determine how well the drug was tolerated. In a phase 1 trial,maximum tolerated dose (MTD) is tested and some of those patients probably received higher doses than you will receive.

      The bottom line is that this new drug provides hope - hope that may be sadly lacking in many cases. And, additional new drugs are in constant development.

      8 months ago
    • carm's Avatar
      carm

      I'm not a patient, I'm an oncology nurse but if I remember correctly, it is a study by MEI pharmaceutical company. It's an open label study with or without rituxan. Best of luck to you.

      8 months ago
    • LiveWithCancer's Avatar
      LiveWithCancer

      I have not participated in it, but thank you for being willing to participate in a trial. I was in a clinical trial for 4 years for my lung cancer. If I ever have the opportunity again to participate in another trial, I will not hesitate to do so.

      8 months ago
    • icrazyhorse's Avatar
      icrazyhorse

      In November 2011, at the age of 64, my wife was diagnosed with follicular lymphoma Stage 4, Grade 3A. She had 50% bone marrow involvement. She is one of the 20% of follicular lymphoma patients who progress rapidly after treatments. In 3 years she progressed after R-CHOP (6 cycles), bendamustine/rituximab (6 cycles), and Ibrutinib (12 months). Then she took Idelalisib/rituximab as her fourth treatment. It worked great for 14 months then a PET scan showed she progressed again. She is now in an NIH CAR-T trial NCT02659943 was infused on March 2, 2016. As of February 18, 2019, she has been in complete remission for 35.5 months. Clinical trial studies show that CAR-T cells may result in long-lasting remissions for some people who have follicular lymphoma. There is more information on CAR-T for fNHL patients and people considering CAR-T at https://fnhlben.wordpress.com/

      Other non-Hodgkin lymphoma sites I visit often are:
      http://lymphobob.blogspot.com/
      http://www.lymphomation.org/#what-is-new
      http://www.lymphoma.org/ (look for free "Ask the Doctor" meetings near where you live)
      http://www.lls.org/

      8 months ago
    • SBK's Avatar
      SBK

      My doctor told me that I likely wouldn't qualify for any clinical trials in the future, so good for you that you can do it. My low grade marginal zone lymphoma transformed to high grade and I just finished Rchop so hoping I am in remission a bit longer than my first treatment which was single agent Gazyva only. Thanks for all the info everyone.

      8 months ago

    Help the community by answering this question:

    Create an account to post your answer Already have an account? Sign in!

    By using WhatNext, you agree to our User Agreement, and Privacy Policy


    Read and answer more follicular lymphoma questions.  Also, don't forget to check out our Follicular Lymphoma page.