Day 10, Saturday, July 21 I woke up with a runny nose. It
only lasted one day and turned into a sore throat, which lasted for a few days.
The physician at NIH said it looked like I had a cold. For the past week I have
had no runny nose, no sore throat, but lots of coughing. Thursday, August 2nd
I coughed up a small amount of what appeared to be dark red blood. Considering
the fact that internal bleeding is one of the side effects of Ibrutinib, I got
a little concerned.
Well the good news is that I am not bleeding internally and
I do not have pneumonia. But I do have bronchitis – a cold that seems to have
worked it’s way to my lungs. So an antibiotic is in order. It’s funny how one
gets overly cautious about the toxic combination of drugs, so I would not take
the antibiotic until I got the okay from Dr. Farooqui. I can’t take aspirin or
Ibiprofin anymore because of it’s blood thinning abilities. No more red wine
for La Verne either (BOO! HOO!), until the researchers figure out the issues of
alcohol and the experimental drug.
I also wanted to mention that it was announced August 1st
that three additional Ibrutinib Phase 3 clinical trials at undisclosed
locations will soon be posted -- two are for CLL/SLL and one is for mantle cell
lymphoma (MCL). Pharmacyclics and Janssen (two drug companies) will begin to
invite participants into the clinical trials any day. The California-based
Pharmacyclics is a biopharmaceutical company developing and commercializing
innovative small-molecule drugs for treating cancer and diseases related to the
immune system. The New Jersey-based Janssen is a pharmaceutical company of
Johnson & Johnson that provides medicines ranging from ADHD to mental
health to neurologics to pain management. Jenssen immediately saw the potential
of Ibrutinib and paid Pharmacyclics $150 million upfront for a worldwide
collaboration. In total Pharmacyclics will potentially receive $975 million for
collaborating with Jenssen on the experimental drug I am taking. Hmmm… Who says
it’s not all about the money?
The three studies will include the following:
1. A random study of the combination of Bendamustine/Rituximab plus Ibrutinib in comparison to
Bendamustine/Rituximab plus a placebo in relapsed or refractory CLL/SLL patients.
What this means is that participants sign up for the clinical study and have a
50:50 chance of getting Ibrutinib or the placebo. Bendamustine (tradename
Treanda) is a nitrogen mustard used in treating CLL and lymphomas. Rituximab is
a chimeric monoclonal antibody, which was FDA-approved in 1997. A placebo is a simulated treatment for a disease intended
to deceive the recipient.
2. A frontline study of
Ibrutinib alone compared to a comparator (Waiting to find out what this will
be) in elderly CLL/SLL patients. Again, as a participant, it is the luck of the
draw whether you get Ibrutinib or not. Also, please note that “elderly” means
you are 65 or older. Most of the participants in my study are fuming at the use
of the term “elderly,” so my doctor calls them the “other” cohort. LOL.
3. A study outside of the
United States for patients with relapsed or refractory mantle cell lymphoma
(MCL), who have received at least one prior chemotherapy regimen. The
participants will be randomized and will receive either Ibrutinib or
Temsirolimus. Temsirolimus is an intravenous drug for the treatment of renal
cell carcinoma (kidney cancer).
Click for the full article:
I thank God every day that I was able to get into a clinical
trial in which every participant received the drug Ibrutinib. I celebrate each
day. I will be forever grateful for this opportunity regardless of the outcome.
“(S)He is a wise (wo)man who does not grieve for the things
which (s)he has not, but rejoices for those which (s)he has.” — Epictetus
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