Is CLL caused by some infectious agent? Even if not all CLL patients can trace their cancer to some infectious agent, is there a possibility that some percentage of patients would not have been diagnosed with CLL but for some infection just prior to their CLL diagnosis? Or an infection long time ago, but where traces of the virus are still retained in the patient’s body?
You might be interested to know, a surprisingly significant percentage of CLL patients report they have had one or more bouts of pneumonia in the years just prior to their CLL diagnosis and I believe this correlation has been documented by NCI researchers.
And then there is everyone’s favorite villain, Epstein Barr virus. In one of our admittedly unscientific polls, we found that a surprisingly large percentage of our members have had clinically diagnosed mononucleosis in their youth (that is “glandular fever” for our British members) – significantly more than in the general population. There is more rigorous research pointing to a connection between EBV and some lymphomas, as well as the dreaded Richter’s transformation.
That brings us to this very unusual clinical trial. In a nutshell, they want to recruit very early stage and good prognosis patients who have not been treated in any way and certainly not ripe for treatment and treat them with nothing more than a cocktail of broad spectrum antibiotics. The logic is that if there is indeed some underlying infection that is just barely simmering along – not enough to be detected or identified but enough to rile up the immune system into a state of chronic inflammation – can we hope that the antiobiotic cocktail will stop that infection dead in its tracks, and thereby stop the cancer as well?
This is not quite as crazy as it sounds. There has been a lot of interest in the role of chronic inflammation as the origin of immune system related cancers. Constant goading by a pathogen into a high state of alert (i.e., inflammation) coupled with an inability to actually resolve the infection and get on with life may indeed cause our immune systems to “go postal” – become cancerous.
My beef with this clinical trial is that they are planning to use only antibiotics. When we have identified pathogens as the cause of specific cancers, more often than not they are viruses. And antibiotics do not work on viral infections. For example, if indeed EBV has a role in the precipitation of CLL, the antibiotic therapy would do very little to stop that viral infection. I wonder why they did not include a potent anti-viral drug in the mix.
Any case, here is the link to this clinical trial. NCT01279252 You can read all about the inclusion criteria, contact information etc by clicking on the link.




11 comments on "CLL Empirical Antibiotic Regimen (“CLEAR” clinical trial)"
Chaya,
Some antibiotics have anti-inflammatory beyond their antibacterial activity. Some antibacterials are also mildly antifungal, and some such as adriamycin are only used to treat cancer.
It is not a crazy idea.
Do you know what antibiotics are being used in the trial?
Thanks for you continued efforts.
On a personal note, I will adding rituximab every 6 months to my ongoing low dose ciclosporin in my unique version of a maintenance program. First I am waiting for my hospital’s new MR as I am switching from CT to MR to monitor my mesenteric nodes. My last BMB showed <3% CLL with just the R 4 months earlier and the continuos ciclosporin, but my nodes are slowly growing.
Trying to put off a second transplant for a couple of years.
That's my plan as of today.
Brian
Brian:
The trial lists metronidazole, clarithromycin, ciprofloxacin and lansoprazole as the four drugs used. Pretty heavy duty stuff. I wonder how long they are administered.
Does anyone know the results of the Phase 1 part of this trial? thank you
>>Official Title: A Phase II Trial of Broad Spectrum Antibiotic Therapy for Early Stage, Non-progressive Chronic Lymphocytic Leukaemia Without Adverse Prognostic Factors
Chaya,
Could you please help me get a better “mental model” of “chronic inflammation” of the immune system? Later you call it as a “high state of alert”. Inflammation is referred to often in the literature, but except for the visual of muscles being inflamed, I have no good mental concept to translate to the notion of an inflamed immune system.
Thanks
Lynn
Elainbe:
Phase I trials are done to define safe drug dosage limits and establish methods of administration. Since the drugs used in this study are all well known ones with known dosage limits etc, it appears the researchers felt there was no need to do a phase-I study and went directly to phase -II. I am not aware of a phase-I version of this study.
LynnS:
One of these days I will try to do a full length article on the subject of inflammation. It is an important subject and worth learning about. Thanks for reminding me.
Thank you Chaya.
I clicked on the link and It looks like this trial is in the UK. I did not see anything that looked like it would be offered in the US. Does anyone know?
I heard a report today that the Union of Concerned Scientists and
the Natural Resources Defense Council among others has filed a suit against the FDA to stop the practice of ‘routinely adding antibiotics to livestock feed to help animals grow faster’….i.e. any use of antibiotics that is not related to animal health.
They are claiming that 80% of the antibiotics in the US are given to livestock and that this practice is significantly diminishing the effectiveness of antibiotics in humans who consume these animals.
Interesting if the study is in the UK…I have not heard any info on the use of antibiotics in the food supply there.
I am pretty sure the use of antibiotics in farm animals is pretty pervasive.
This problem (along with excessive use of antibiotics in humans) will only get worse over time, as more and more bugs become resistant .
There is something to be said for using the bullets we do have wisely. Invention of new antibiotics is lagging behind overuse and drug resistance by a big margin.
Interesting notion using antibiotics and it caught my eye since I was diagnosed about 4 years ago when I went to the dr for “spider bites”, I thought on my leg. I was given just one course of doxicycline (may not be the correct spelling) but it was a broad spectrum antibiotic. I remember that after taking it a few days looking at myself in the mirror and thinking, “I haven’t felt this good in years”. I was only 54 at the time so that is not old by any means. I am anxious to see what this trial will bring but like someone else here said, it looks like it is only in the UK. With my previous experience above I wonder if this might not be the perfect clinical trial for me.
I blame my CLL on a wasp. My mom had CLL also, but I was 47 when a wasp stung me under the arm at the back of my breast, which welted up and hurt for hours, also under my armpit I had welts. 6 months later I was diagnosed with CLL. The only thing that showed up was a larger lymph node in this same area, where I had been stung by the wasp. They biopsied the node because of my high white count, and did the fish testing, markers, etc. I noticed this trial says you can only have 2 adverse markers to be included. I have 13q, 11 deletion and higher CD38. Zap 70 neg, and mutated IVG. Is 13Q deletion considered adverse? Do I have too many adverses?
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