October 6, 2007
by Chaya Venkat
Readers of CLL Topics who have been with us for more than a year know we have been trying to get a clinical trial going, affectionately named “Jab & Dab”, in the hopes of improving the efficacy of flu vaccinations for CLL patients. I am delighted to report we have finally achieved liftoff: the clinical trial in the UK that we are sponsoring is finally ready to recruit patients and in time for the upcoming flu season. Looking at the early indications coming in from Australia (remember, the Aussies get the flu season ahead of us), it looks like it will be a nasty one this time.
Listing in Clinicaltrials.gov: NCT00596336.
Links to our previous articles on this subject are given above, and I strongly urge you to read them to get all the details. But for your convenience, here is the cheat-sheet version:
If you are one of the lucky few that get a letter of invitation to participate in this trial, I hope you will sign up for it. I would, in a New York minute. Even a small improvement in the percentage of CLL patients who respond to flu shots will mean many lives saved and much suffering prevented. And the results could have much more significant value, in the sense that we are not the only immune compromised patient community. The same concept may be of value in other groups of people with less than pristine immune systems. Proving the concept in a well conducted clinical trial with unimpeachable expert supervision will be very valuable.
I am very pleased with the clinical trial protocol. It has a terrific design. The target is to recruit sufficient number of patients to yield statistically meaningful results. There are adequate and well matched control groups, both with and without CLL, who will get only the regular flu shot and not the imiquimod ointment. Using spouses of CLL patients as the control group is a stroke of genius! This way, our control group of non-CLL patients will be roughly the same age, exposed to roughly the same family and community and therefore share similar risk profiles. By using patients who have already been tested for the various prognostic indicators at the Bournemouth Hospital as the standard CLL patient workup, the trial will be saving a ton of money that would otherwise be needed for characterizing the participants. All in all, I think this is one heck of a good trial design. Kudos to the researchers!
Imiquimod (“Aldara”) has an enviable safety profile in human use. People at risk of skin cancer (“actinic keratosis”) or even full blown squamous cell carcinoma have been using this FDA approved drug for a while. In fact, recent guidance suggests that after basal cell cancers are removed by Moh’s surgery, it should be followed by Aldara use to prevent recurrence of skin cancer. Skin cancer patients use the imiquimod ointment on large areas of skin, for months at a time, with few adverse effects. As a participant in this trial you will be using it for just a few days, in a small patch right at the site of the flu shot. I cannot think of a lower risk profile than that.
Will you personally benefit from participating in this trial? There is no guarantee of that, there is no guarantee that this concept will even work, and that is the honest truth. That is precisely the reason for doing the trial in the first place, to find out if it works! Whether or not the trial is successful, the information we get from doing this trial will be invaluable. And generations of CLL patients coming after you will thank you for your participation in this trial.
Last but not least, what about patients who want to follow the Jab & Dab protocol outside of the official clinical trial?
Obviously, I cannot give you medical guidance and I am certainly not qualified to do so. I have no desire to practice medicine without a license, nor do I want to encourage you to be reckless. Just as obviously, I cannot stop you from doing anything you want to do. So, here is what I want to get across to you. Self-medication without appropriate guidance from your doctors is a foolish thing to do. I cannot say this in any stronger terms. Nobody, and I mean nobody, should be considering doing this protocol on their own, without getting advice, consent and supervision from their local healthcare providers. By all means, please print out the clinical trial protocol and the patient information sheet for your doctor to study carefully. Imiquimod is a prescription drug, and not cheap either. Be smart, be sure to get medical guidance and get your doctor’s approval before you indulge in “experimentation”. This is not a coy ‘CYA’ caveat on my part, I really mean it.
I also want to point out a simple fact of life. A boatload of anecdotal evidence based on individual patients and what they do with the permission of their doctors will carry no weight. We absolutely need the results of a well-documented, well-conducted and officially sanctioned clinical trial before anyone will take this concept seriously. So, all you guys who get to participate in this trial, thanks from the rest of us. We wish you luck, and to be honest we are just a tiny bit jealous of your good fortune in being able to participate in this trial. With luck, your efforts will make it possible in the future for many more of us to get our annual flu shots with an immune adjuvant such as imiquimod and thereby be better protected by the vaccination.
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