Not too good to be true
I would like to have a dollar for every time I talked about there being no free lunch for CLL patients. Well, this is about as close to a free lunch as we are going to get folks. And in my opinion the menu is pretty darn tempting. I am familiar with this trial as well as the principal investigator who is conducting it. I cannot say enough nice things about either of them.
- Are you a CLL / SLL patient that has not yet received any therapy?
- Perhaps you do not even have CLL / SLL (yet), but you have the tell-tale signs of MBL we just discussed in the last Updates article?
- Do you want to get state of the art monitoring for this confusing and still incurable cancer? And I mean really cutting edge stuff, some of these tests are not yet available from commercial labs.
- Do you want to get full slate of prognostic testing done, including bone marrow biopsies etc, with zero hassle?
- Do you want to have access to gold standard therapy options down the road when and if it is time to treat? Up to and including stem cell clinical trials at the National Cancer Institute, if that is what your clinical situation indicates?
- Do you worry about the ever increasing co-pay components of your health insurance?
- Do you even have health insurance?
- Are you worried about losing your health insurance if you get laid off in this miserable economy?
- Last but not least, do you still have enough idealism left in you that you want to do what you can to help the CLL patient community?
NCI Study (all of our tax dollars at work)
If some or all of the above bullet points describe your situation, then read on. This is one clinical trial I can recommend with no reservations. Here is the link to the trial where you can read all the official information. I have highlighted some of the more interesting bits below for your convenience. As always, you can write to me off-line if you wish further clarification or just want to walk around and kick the tires, as it were.
- The study name is: NATURAL HISTORY STUDY OF MONOCLONAL B CELL LYMPHOCYTOSIS (MBL) and CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL)”
- Diagnosis of CLL/SLL will be made according to the NCI Working Group and the WHO diagnostic classification. A lymphocyte count (ALC) in excess of 5K is typically found in CLL but is not required for a diagnosis of SLL.
- Patients with tell-tale clonal B cell population in the context of MBL can have ALC less than 5.0K and are still eligible for inclusion in this trial. I know of no other study that does that.
- Patients with familial CLL are eligible.
- You must be older than 18 years and in sufficiently good shape (and by that I mean you should be able to get around, dress and feed yourself etc. You do not have to be an exercise jock capable of running marathons).
- You must be competent to sign an informed consent, and sign the protocol consent form. If there are things on the consent form that you do not understand, make sure you check them out with your friendly neighborhood patient advocate.
- Upon discussing the inclusion criteria described in the link with the researcher in charge, I have further clarification: a history of autoimmune disease and swollen lymph nodes are not (repeat, not) exclusion criteria. In other words, if you already have swollen lymph nodes, you can still participate in this study. If you have active autoimmune disease right now, you should discuss your situation with the researchers to see if you are eligible to participate.
- NCI will do all routine type and prognostic evaluations (Flow cytometry, FISH, IgVH, ZAP70, extensive lab workup), as well as a CT scan at baseline. They may do PET scan in patients with swollen lymph nodes.
- If you have not had a bone marrow biopsy done on the outside, NCI will do that as well. Frankly, I think you are better off getting all this testing done at the NCI, especially the bone marrow biopsy. Results of a bone marrow biopsy are only as good as the experience of the pathologist looking at the slides – and commercial labs out there are not in the same league as the NCI. Also, commercial labs do not retain samples from the biopsy for later use. Who knows but your sample may need to be reexamined later on, as we learn more about this disease.
- True, they will probably want a few more tubes of blood etc from you than your local strip-mall oncologist. Afterall, this is a cutting edge clinical trial and they are trying to learn everything they can about this frustrating disease! I hope most of you do not see this as a downside. Instead you should see this as a positive thing, a way in which you can make a huge contribution to this patient community.
- As with any clinical trial, volunteers have the absolute right to drop out any time they want to.
- And before I forget, you do have to be legally in the United States in order to participate in this trial.
OK, now for the punch line
What is the cost of all this state-of-the-art tender loving care? Zero dollars.
I am not kidding, that is why I called this clinical trial the proverbial free lunch. No medical insurance required, no co-pay, no hassles with insurance companies refusing stuff because they are trying to save a few dollars. It does not get better than this in terms of cost or sheer expert care.
From the perspective of the CLL patient community, the faster this trial finishes recruitment and gets off to a good start, the quicker we can expect to see some real understanding of what makes this disease tick, the better our chances of getting an actual CURE down the road. By monitoring patients from the get-go, by leaving no stone unturned in terms of prognostic and molecular testing, by including even folks with MBL, this is about the most comprehensive clinical trial I have seen to date. And all of it is for free of charge to you.
Yes, you do have to make the trip up to Bethesda (Maryland) a couple of times each year, or as often as your situation requires. But airfares are cheap if you plan ahead, and same goes for hotel stay for a day or two. I understand there is some assistance available for travel expenses of patients recruited for this clinical trial, you should check into it if that is an issue for you. Also, a little bird told me there are all sorts of wonderfully generous volunteers out there (including my wonderful daughter and son-in-law!) that will put up patient volunteers in their homes for free. I will be happy to introduce you to a very nice social worker at the NCI who will help you make the contacts, if you need this additional help with costs.
If in addition to the monitoring at the NCI you wish to have regular monitoring of your CBC etc locally, that is acceptable. NCI will work with your local guy and incorporate your lab work into their own clinical assessment. Obviously, any tests you get done locally will not be paid for by the NCI.
Last but not least, I do not know how one goes about putting a value on sheer peace of mind. I hear from so many patients who are frustrated because they worry about the service they are getting from their local guy. Not every CLL patient is a science geek, not everyone wants the responsibility of driving the bus when it comes to making sense of complex lab information or making therapy decisions. As we have reported in a recent article “To wait or not to wait” on Updates, none of these are slam dunk choices.
Having access to one of the best cancer centers in the world, a top rated researcher (so rated by his peers and by me too, for what that is worth) that will consult with you without having one eye on the clock because his HMO employer insists he cannot ‘waste’ more than 15 minutes per patient, therapy decisions that are not made on the basis of shaving a few dollars off of the cost – what is that worth to you? What value will you put on having confidence that you will get “Best Practices” care, that things will not slip between the cracks because it just so happened your local guy did not take that particular CME course?
The researchers hope to enroll 230 patients; they have already enrolled about a dozen. I cannot imagine these slots will stay open very long given the status of our present healthcare situation. May I also request each of you to get the word out about this important trial on all the other internet forums. Go get ‘em Tigers!
Please refer to this study by its www.ClinicalTrials.gov identifier: NCT00769743
Therese White, RN
National Cancer Institute
Bethesda, Maryland, United States, 20892-1182