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!
Contact information
Please refer to this study by its www.ClinicalTrials.gov identifier: NCT00769743
Therese White, RN
Research Nurse
National Cancer Institute
Bethesda, Maryland, United States, 20892-1182
Email: whiteth@mail.nih.gov
Phone: 301-402-5886
137 comments on "A clinical trial perfect for our times"
WOW! Makes me wish I lived in the States! Marcyne
WOW indeed. I am so pleased to be able to tell you guys about this trial.
In the past few years a clear consensus has emerged among experts that not all CLL is the same and not all CLL patients should be treated the same way. We discussed some of the issues in a recent article “To wait or not to wait”. One shoe does not fit all patients.
For most patients cared for by local oncologists, the best we can hope for is getting standard prognostic testing (IgVH, FISH, B2M, CD38, ZAP70) done at one of the commercial labs if our insurance company is willing, and further hope that our local guy believes in all this new fangled “nonsense” having anything to do with therapy decisions. Most likely, a lot has changed since he went to medical school, slam dunk choice of single agent fludarabine is hardly the right decision any more! This is truly a case of “Future Shock” and local healthcare providers are having a lot of difficulty keeping up with the latest research findings or Best Practices.
The kind of detailed prognostic and molecular profiling that the NCI will do in this clinical trial is not available anywhere else, period. Patients lucky enough to be in this trial will get therapy decisions made on the basis of their specific situation, and therapy will be initiated at the most appropriate time. There is a lot of security in having access to that kind of care.
Afternoon, Chaya…
I just noticed a possible discrepancy in patient eligibility…
You said above: “a history of autoimmune disease and swollen lymph nodes are not (repeat, not) exclusion criteria.”
But following the link you give above to ClinicalTrials.gov I find:
PATIENT CHARACTERISTICS:
* No history of autoimmune disease
Could you clarify this? Or am I missing something above?
Harley
My sister and I are in a study at NIH on familial CLL, likely inherited from our father. The study is very comprehensive, the people are caring and fabulously skilled. Additionally, if they have concerns about any other problem they find, maybe a mole that they aren’t sure about, they can call in other specialists from the facility. Since I am in health care, I have enjoyed talking to the doctors about the latest CLL news from the international conferences and journals. You won’t get service and studies like those you get from NIH at your local doctor’s office. Since I am asymptomatic, I count on NIH to let me know when and if I need a local oncologist. This is a wonderful opportunity, don’t miss out.
Alice, in Michigan
Chaya,
You are THE GREATEST! I’ve been on W/W for 12 years and strictly WB Count with no other problems. This looks interesting…let’s see what they can come-up-with using my medical, and nuclear industry history etc.
WillB
Harley:
The inclusion criteria on the ClinicalTrials.gov have been changed and they have not gotten around to making the changes. The information I gave above is the latest (correct) information.
I specifically discussed the issue of autoimmune disease as exclusion factor with the researcher in charge, and I am pleased that it is no longer a slam dunk exclusion criterion. If patient has active autoimmune disease that is presently under treatment, that is something that should be discussed with the researcher to see if it is still possible to register for the clinical trial.
Chaya,
Did you also discuss lymph node involvement as an exclusion factor? The trial details on both the clinicaltrials.gov and cancer.gov sites list “No evidence of lymphadenopathy” under entry criteria.
Thanks,
Tim
PROBLEMS WITH EMAIL ADDRESS IN CONTACT INFORMATION FOR THERESE WHITE.
I am sorry to tell you Therese is having some problems with her email address. If you have written to her and your email bounced, you are not the only one. She is aware of the problem and trying to get it fixed. Please be patient. I will post here again if there is a change in the email address, or one that works better.
For now, hang tight and keep your powder dry. I promise to get back to you ASAP with better working contact information.
Sorry for the hassle! Why do these things happen at the worst possible time? Peter’s principle at work, I suppose.
Chaya
Tim:
Yes. I discussed the lymph node issue also with the researcher. The information I give above is the latest and correct information. Patients who have swollen lymph nodes are eligible. Repeat, evidence of lymphadenopathy does NOT exclude patients.
Chaya:
The current trial writeup as Tim pointed out precludes patients with lymphadenopathy. Can this be clarified.
Nowhere in the trial writeup is treatment mentioned. Is it implicit that one would or could get followup treatment at NCI?
From what I can tell in the writeup, this study is seeking to look at the advanced diagnostic tests to see if they have any merit in guiding treatment. The study is more of a blood and tissue data base along with real time measurments of the patients characteristics. It seems that microarray data are to be studied and that seems new.
In some sense this trial overlaps the one Dr. Kay at Mayo heads which has been ongoing for about 5 years and is much larger than the NCI recruitment target of 230 patients.
Mickey:
I answered the question regarding lymphadenopathy above.
This study looks to follow patients all the way from diagnosis and through treatment when it becomes necessary. So, yes, the answer to your question is that the study INCLUDES treating patients with the most appropriate therapy at the time when treatment becomes necessary.
I discussed this at length with the researcher. NCI will provide all the necessary therapy as well, as continuing aspect of this clinical trial. I am told even a stem cell transplant is included, if it becomes necessary, and the patient fits the profile they have for their stem cell transplant program. Presently the NCI has two stem cell transplant programs on their books, one for matched sibling donor transplant and one for matched unrelated donor transplant. Obviously the patient’s access to these two programs depends on having either sibling or matched unrelated donor available.
The take home message is this: this clinical trial is indeed soup to nuts. It goes from diagnosis, prognostics and monitoring, Watch & Wait, eventual therapy and even a stem cell transplant (if donor is available etc). I am pretty sure of my facts on this front, but of course you should check it out to your own satisfaction when you contact the NCI.
You can tell I am really excited and pleased with this opportunity that has become available to our members. Times are tough, many of us are facing insecure employment / financial and healthcare insurance issues. This clinical trial is a godsend to patients and their families who are otherwise looking at a bleak and insecure situation. How does one choose between paying for the needed healthcare of a beloved family member or keeping the mortgage payments up to date? How do we face a future where there may be a pink slip in the mail, with loss of medical insurance soon after?
But please understand this trial is open only to patients who have not been treated yet. If you start therapy now and want to get into this trial a few months down the road if your insurance situation changes, you will be out of luck. Something to think about.
Dear Chaya,
Thank you very much for this news. In other notes you’ve written, you have mentioned that you think that the risk from the radiation from the CAT scans is small compared to the knowledge gained. Would you say this is true for me, W/W for 2 years, WBC 12K?
Thank you so much.
Tom
Hi Chaya, I just e mailed Therese so I hope she receives it. If it isnt kicked back to me am I to assume she received it? I wonder how come Toms oncologists never mentioned this clinical? Thank you for keeping us informed of all things CLL! Eileen
Tom:
CAT scans do have some radiation exposure. The answer to your question depends on the specific situation, whether there is a diagnostic need for the scan. I am not a big fan of unnecessary scans performed just because. It helps neither the patient nor our national healthcare budget! At the same time, I think it is foolish of patients to refuse to get a CAT scan when the information such a scan can provide is important and NECESSARY for making therapy decisions.
If your doctor is suggesting a CAT scan, the first order of business is to ask him why he is suggesting it, what he hopes to learn from it, and how that would benefit your care. Your decision depends on being satisfied with the answers you get to these questions.
Dear Chaya
Thank you for this information. I have been on W and W for 2 1/2 years and I do not have a local Oncologist. I just got off the phone with the NCI and I will participate in the trial if they will have me.
Thank you again
Bob
Therese White sent out this email to the folks who had called and left a message on her machine. Her phone has been ringing off the hook, pretty much what I expected. If you are interested in this trial, please be patient and do not give up just because you have not heard back in a few days. If by the end of this weeek you have not yet heard back, write to me and I will troubleshoot for you, OK?
************************************
Greetings,
Thank you all for your calls and emails expressing interest (for yourself or your spouse) in our NCI protocol in which we are studying untreated CLL and MBL. I would appreciate the opportunity to talk to each one of you but it may take me a day or so to reach everyone. For now, I am sending out this general email to let you know that I did receive your email and will work furiously to contact you.
Please know that we have many openings on the protocol and should be able to evaluate each one of you over the next few months. Please let me know if there is a good time for me to call, especially those of you in other time zones; MST and PST. It is now DST here in Bethesda, MD.
By the way, we see new patients on Thursdays, so I will be trying to schedule appointments for you on Thursdays.
Thank you in advance for your patience and I hope to talk to you soon.
Therese
301.402.5886
Eileen:
If your email to Therese bounced (you are not the only one this has happened to), you can assume she DID NOT GET IT. Call her and leave a message on her phone. Her number is 301-402-5886. She promised she will get back to everyone within a couple of days. She has been swamped with requests!
Dear Chaya, sounds like my perfect cup of tea. thank you Howard
HEY GUYS, HOW ABOUT DOING THE CLL PATIENT COMMUNITY A FAVOR?
How about getting the word out about this trial on all the other internet forums where you may be a member, and getting some buzz going? You are welcome to provide a link to this site, or if you wish, I will waive our copyrights on this occasion and give you the right to cut and paste my article.
The important thing is that we need to try and make sure everyone who can benefit from this trial has access to the information.
All of us benefit when we each pitch in. I am a firm believer that each one of us is our brother’s keeper.
WOW
This sounds like great news. by the description of requirements I am a good candidate. I have left a message for Ms. White an waiting a call back or eamil.
Thanks for the info!!
Eric
This is really good news. I just had my email bounced back from Nurse White’s server, so the email issue has not been resolved.
I did leave a telephone message, so that still works.
Chaya, thank you for alerting us to this important trial.
THERESE WHITE’S EMAIL ADDRESS IS NOW FIXED AND YOU SHOULD BE ABLE TO GET THROUGH TO HER. Email: whiteth@mail.nih.gov
Sorry for the hassle folks.
Thanks Chaya, for the heads-up on this trial. I am putting my body where my mouth has been. This is exactly what every patient needs. I have called and emailed with no response yet. I’ll keep you posted.
I would like some help finding lodging.
WWW
My husband participated in a clinical trial which used Cladribine in a MINUTE dose. It brought down his WBC to such an extent that he was no longer able to complete the trial. Do you think he would qualify for this trial? Judy
Judy
You should check with the NCI to see if he is eligible. Hey, nothing to lose by trying, right? They say previously untreated, but perhaps he got so little cladrabine it can be overlooked. I don’t know, you better check with them to get the straight scoop.
Dear Chaya,
You had very generously corresponded with me and taken phone calls from me last summer regarding my husband’s CLL and a referral to Dr. Wiestner at NIH, while you were dealing with your own heartbreak and PC’s passing and we can’t thank you enough for your unselfishness. My husband joined this trial last fall and I can’t say enough about the excellent experience it has been!!! Therese White is a superb, caring and wonderful communicator, and makes sure that her patients are informed each step of the way. The honor of having the experience and recommendations of Dr. Weistner and Dr. Marti has been a tremendous relief! We finally feel like we have a plan….and a good one…to follow my husband’s progression. He is one year W&W with unmutated IgvH. We believe this type of research is imperative. My husband’s mother passed away from leukemia, type unknown, at age 64, and we have 3 daughters. The familial link is quite a concern for us. Chaya, we continue to be deeply appreciative to you, PC and CLL Topics for all of the information that you share with this community.
I would add only one footnote. It was our understanding when my husband signed up for the Natural History Study at NIH that once he needed treatment, he would go off study. The NIH team would direct him to the treatment facility or plan that would best serve his needs. That treatment facility COULD be NIH, if the fit is right. But, then that would be another clinical trial. But, this to us, only seemed to be a good thing! Therese White should be able to clarify.
Again thank you for sharing the information about this study. My husband sees a local oncologist, who happens to have done his Fellowship at NIH and knows Dr. Weistner. We have worked it out thus far that my husband sees his local oncologist at one 3 month interval and then returns to NIH at the next 3 month interval. The lab work is done at both places and shared. This works well for us in terms of travel and any overnight expense. However, NIH does reimburse some of these expenses.
We would be happy to share more if anyone has questions about our experience, but Therese is the key and will give you an answer for every question.
Best regards,
Kathy
Chaya thank you so much for finding out about this study! I called and left a message as well. I hope I won’t be excluded because I hade weight loss surgery last June. My white count has been steadily climbing since then.
I’m glad I called and left a message as my email bounced too.
Guys, there was a typo in Therese’s email address as we had it originally (there is a “t” missing). Mea culpa. It has now been corrected. But you may still be using the old email address you picked up from the site earlier. Please try this corrected email address below, I am sure you will get through.
whiteth@mail.nih.gov
Thanks Chaya
Kathy from NH, hello fellow New Englandah. My e mail address is stargazerlily17@aol.com and if you wouldnt mind connecting with another family impacted by this disease. Eileen
Has anyone found out whether this study will include treatments? I have sent an email to Theresa and am waiting a reply.
Thank you for alerting us of this study. I have contacted NCI, submitted my info. and am waiting for Therese White to contact me. I live in Maryland so travel will not be an issue for me.
Pat Hagermann
There has been some confusion on what exactly is included in this particular clinical trial protocol, and what else the patients will have access to at the NCI/NIH when therapy time rolls around. Here is the scoop.
This protocol describes the front end; it involves the prognostic testing, characterizing and monitoring of patients from diagnosis through the Watch & Wait period. When patients progress and need therapy, they will be counseled on their therapy options and can dovetail into the state of the art therapy protocols available at the NCI/NIH at that time. For example, right now the frontline therapy of choice at the NCI/NIH is Rituxan + fludarabine. (We have several detailed reviews of RF therapy on our CLL Topics website. This combination was extensively reported on a couple of years ago by Dr. John Byrd et al at Ohio State University)
They also have a Revlimid based protocol for patients who relapse after RF (or FCR, if that arm opens down the road). Patients will also have access to mini allo stem cell transplant programs at the NCI/NIH, provided they have suitable adult donors available and it is the right therapeutic choice in their specific case (one of the transplant protocols is for sibling donors and the other is for matched unrelated donors, we have reviewed both of them extensively on CLL Topics website.
If the patient desires something other than the therapy options presented at the NCI/NIH, they are always at liberty to drop from the trial and get the therapy of their choice locally or at one of the other cancer centers.
If you have any further questions, I strongly urge you to get answers from Therese White. I hear she is getting a lot of phone calls and emails (use the correct email address please! whiteth@mail.nih.gov ) and I know she is working hard to accommodate requests for a visit at NIH and get patients any additional information they need. I met Therese a couple of years ago when PC and I visited the NIH. You can’t ask for a nicer person or more knowledgeable RN. I know you will be in good hands with her.
My thanks also for getting this information to us. My husband has emailed and received a conformation from NCI. His oncologist feels more advanced testing is not needed until things advance further so we have no idea where he stands other than his CLL diagnosis 15 months ago and the steady climb of his WBC. I know everyone, as we are, is grateful for the bounty of information on CLL Topics.
I am passing this on for anyone that was waiting for an answer to my same question…
Dear April,
I received your email. Thank you for your interest in our study; I will respond soon with more information.
Therese
PS Rani Kota is my colleague and will be helping me send information to interested patients.
In response to your questions: I apologize for the confusion. The CLL study that Chaya posted does not include treatment. Please stay tuned and I will get more information to you very soon.
Chaya:
Thanks so much for the information. Do you know if there is an age limit, such as senior citizen? I am 76. does that fit in, you mentioned young age but as we are thinking, am I to old. I have no symptoms except for high normal WBC and high lymphocites, low neutriphil. Although diagonistic test confirmed. It has been 4 years. See my oncologist every 6 months.
Ken
Ken:
I am not aware of any age restriction to this study. There is a general fitness criteria, but a lot of men your age have no problem passing that hurdle. I suggest you check with Therese to get additional details.
Greetings again,
I have read with interest all the notes posted here over the past few days. And I thought I would post a quick note (sorry…not so short!)directly.
I am making progress in reaching all the wonderful people who have contacted me for information about out NCI CLL study. My colleague, Rani and I have almost completed a list of all those who have emailed or called for information about the study and I think I have reached all but a few. It is my hope that we will have a complete package of information ready to go out no later than Friday. We will send the package via email for those who have given me their email address or we will send the documents via USPS for those who request it or who do not have email access.
I will include the following in the packet:
1) Letter describing the process we will use to arrange appointments for those interested in being evaluated for the study. The letter will also include instructions for sending medical records and biopsy slides, if applicable.
2) List of hotels in the Bethesda area and airports that serve our area.
3) Directions to NIH
4) Information about security on the NIH campus
5) Two consents: one will be the protocol consent; the other will be a “screening consent”. The second one allows us to evaluate you for study eligibility and will need to be signed by the patient on arrival to the NIH.
Thank you again for your interest in our study and for your patience as we prepare for your visits.
Therese
PS One more thing…Thank you for the kind comments several of you have made here and in your emails. It is my pleasure and honor to do what I do.
Chaya,
Thank you so much for the notice regarding this study. Terry’s email bounced so he called. He got a return call from NIH today asking for his email and address. The kind comments about NIH from other comments are reassuring.
As a Retired Vet he is eligible for government care, but this study assures he and many others can afford the study if chosen. He was dx in early 03.
Terry’s oncologist. is testing at 90 day intervals because his platelet counts bounced up and down over the past 15 months.
Terry lost his well-paid job in July and is still unemployed at age 61. He is not sad about the situation because since then he’s had only one infections requiring treatment and none of the problems he had while working. He sleeps more and feels better all around. He’s also sassy rather than being “down” and exhausted.
We’ve traveled extensively by car and air in USA and to Italy to see one son and his family. He resisted even our granddaughter’s colds. He’s seriously thinking of moving us from the NW to Ohio or the South. Okay by me.
I’m pleased to see so many interested in this NIH study. This is the first thing Terry’s taken an active role in pursuing since a patient conference in Columbus within a year of dx. I don’t mind researching, but I wanted him to be proactive in his care. I think this will do it, plus he has extra time.
Linda, spouse
Chaya,
Thanks so much for getting this information out to those of us in the watch and wait stage. I have contacted Therese and without delay she answered me and will have the evaluation packet sent to me in the next few days. I am grateful to have stumbled on this through another forum that I receive daily. I hadn’t been reading it in the past week or so and am glad there was this opportunity for us to be a part of.
Now awaiting my email letter.
Anita
Chaya Thanks so much for the information. I wrote to Terese and my doc sent the papers in. I am waiting for Terese to e-mail me. I live in Ga. It takes about 10 hours to ride up there. Kathy
Has anyone heard back from Therese on whether or not they were accepted into the study? I wonder how long it will take to evaluate everyone’s reports and find out if we are accepted. I feel like I am waiting on my college acceptance letter.
Karen Heston
Karen,
Have heard nothing yet.
Pat
Karen,
I received an email today from Rani stating she received my records.
Pat
I’ve received an email a couple of weeks ago that they have my records. I think the response has been pretty good and they are just working through it all. I’m anxious to find out but assume I’ll hear something before long.
Dan
i received a call today and have set up the screening for June – Therese has been doing her best to get to everyone. I just didn’t know if it would take days, weeks, or months. I look forward to the trip
I had my semiannual checkup yesterday with my oncologist (still in watch and wait mode) and he asked if I had heard from the study team. I told him no, but earlier this morning I sent Rani an eamail asking if they wanted my most recent CBC and clinical notes. She got right back to me saying, yes, and that Therese would be contacting everyone soon. So, I assume I’m still under consideration.
Relax, folks. Unless there is a specific reason why you do not fit the inclusion criteria (and I doubt that will be the case with many people since the criteria are pretty broad), every one of you will have the option of enrolling in the study.
The NCI was a little overwhelmed by the level of response they got from our members. They were planning on recruiting at the rate of a couple of patients each week at best, and they got heck of a lot more volunteers than that after we published this article. But there are enough slots to fill and each of you will hear back from Therese. Just be patient, OK?
I must say I am tickled pink – looks like when CLL Topics speaks, patients listen.
Chaya I go for my appointment to be interviewed May 26th. I’ll let you know how it went. Thank you again for the information. Kathym
Chaya,
Just received an email confirming I am headed to Bethesda for the formal evaluation! Will be setting my appointment later today. Looking forward to meeting you in Niagara Falls later this week.
Jim L.
Chaya –
I am 7 mo post Dx CLL. And I am an MD. Found it myself by feeling my own cervical nodes. (Therefore I read with interest your other MD poster). I am not an oncologist – but I pretty well got my “self board certification” in CLL within 3 weeks – reading all the literature out there. Worrying. Then found out ZAP70(+) and Trisomy 12(+). Crying. Hoping. More angst. Spent the 1st three months losing 30 lbs – not from CLL – from depression. Now am doing better. Signed up for your listserv in my internet-scouring. All your topics are top-notch researched, and deal in state of the art info at patient level “speak”.
Found out about the NIH trial for newbies through your listserv. Immediately called and signed up. got my appt. went there. All in all great people. Dr Wiestner very impressive. Therese very kind. I was accepted into the study.
Believe it or not – many doctors do not have unending funds, and some of us, unfortunately, got CLL soooo young that they haven’t yet built a good enough nest egg, the 40lKs are now “201Ks”, and I can’t afford to retire yet, and therefore money is a BIG BIG DEAL – both the spending of it – even with insurance – on co-pays and deductibles for hugely expensive lab tests – as well as losing time from work for BMBx’s, labs, and appts – not to mention the time to be lost in the near future from chemo and its complications. Therefore – free advanced lab testing, free BMBx’s, Free CTs, Free state of the art care and free recommendations all very much welcomed.
They were very careful at the NIH to state that entrance into this study does not guarantee entrance into a treatment study if and when I need it – though it was winked-and-nodded; and besides, I would hopefully be looking for FCR not FR to get as good a CR as possible, again, being so young. Hopefully they will add / change protocols by that time. Anyway, I this study truly is top-notch – take it from a doc. I value being in it. Many Thanks to you for being a great help to a “suddenly sobered soul”. Keep up the great work. If you like I’ll keep you posted – though in truth I hope to be able to tell you I’m still in W/W
Hotdog
Chaya,
I want to thank you again for letting the CLL community know about this study. I had my appointment yesterday and was accepted into the study. The experience was very positive from everyone. Therese is doing her best to keep up with the overwhelming reponse to this study – so be patient.
The doctors (there we four and a PA) and Therese answered all of my questions and re-assured me about managing the CLL and that I was getting high quality care at home.
Thanks again and bless you!
Karen
Is there anyone from California who has been accepted into the study? I’m trying to decide if it makes sense to do the cross country commute. On the other hand, it sound pretty incredible. Any more comments from anyone participating/
And, of course, thank you so much Chaya for posting about this.
Lynn
I had my first appointment for this study earlier this month and was very happy to be accepted. Everyone was so helpful and informative. I know they are helping with travel to and from the NIH and have a travel agency right at the facility.
I can’t thank you, Chaya, enough for this website and the updates. Everyone asks me how I know so much and it is all thanks to you!
I was accepted and I go July 23 to enroll into the study. Dr. Marti talked with me. They have a great staff.
I’m one of the lucky ones to be accepted for this trial study. My first appointment was October 6th 2009. Recently my local oncologist recommended I begin treatment. From the CBC records I’ve kept over a period of years I could not agree with his rationale, so I declined. When I comunicated re: this with NIH staff they offered to provide a second opinion which is scheduled for January 13th. How fortunate I am!
Thanks Chaya for sharing your expertise and alerts.
Dale
I am so pleased how well this clinical trial is serving the needs of our patient community. Kudos to Therese, Drs Wiestner, Marti and others who are involved in this study. Congratulations to all of you who have been accepted into it! You are in good hands. If you are on the waiting list, be patient and stay in touch with Therese!
Follow up to my previous post:
I’m pleased to report that my NIH team of doctors has agreed that I do not need treatment at this time. Perhaps one of the signifcant factors, in addition to reviewing the slides of my recent bone marrow study, was the fact that I had prepared a chart of my blood counts covering the last three years which showed the range of variations which have been consistent though my bone marrow function is reported to be about 10%. Thanks, Chaya, for making the chart available!
I’m told that there are many more spots open for participation in this trial study.
Hello Chaya and all of you who keep in touch through Clltopics. I realized this morning that an update may be helpful for those who are still waiting to hear from us regarding the CLL Natural History Study being conducted at the NIH.
Many of you have heard that we transferred the study from the National Cancer Institute (NCI) to the National Heart Lung and Blood Institute (NHLBI). Most of the changes should be invisible to you, as the protocol has not changed and the physicians involved remain the same; one noticeable change is that Susan Soto, a research nurse in NHLBI will now be the research nurse for this study and your new contact person.
Susan and I worked together for the several months prior to the transfer of the protocol, to make the transition as smooth as possible for you. She has assumed full responsibility for the protocol. She is continuing to arrange for interested individuals to be evaluated and she is coordinating return visits for those who are on-study or waiting to be enrolled after their evaluation.
It was last March when Chaya posted the notice about our study on Clltopics and we were pleasantly surprised to receive so many calls and emails asking for information about the study!! I know that many of you have been waiting almost a year to be scheduled for an evaluation visit. We apologize for the long wait but please understand that Susan will continue to work diligently to schedule appointments for anyone who wants to be considered. We wish we didn’t have to make you wait so long but we have other studies to manage along with this one and we have to work with the resources we have and follow the guidelines of all our studies.
When we transferred the study, I gave Susan all the names and contact information for those who contacted me about the study. I also gave her the records that I had received. She keeps a running list of all interested individuals and makes arrangements for as many evaluation appointments as the doctors and our system can accommodate. It will take us quite some time to evaluate all the people on our list. We ask for your patience and understanding as we continue to meet your requests.
Susan’s contact information is as follows:
Susan Soto, RN
Research Nurse
National Heart Lung and Blood Institute
301.402.0797
email: sotos@nhlbi.nih.gov
It has been my pleasure to meet many of you in person and I wish you and those I have not met many years of W&W!!I think you will enjoy working with Susan and the NHLBI CLL doctors.
Sincerely,
Therese
I had thought I was on the edge of treatment, so turned down a slot in December for this study. However, now that I’m better educated (thanks to Chaya and other posts from the CLL community) I realize that my WBC is only part of the story. As my oncologist has said I don’t need treatment now, I’m planning on participating.
I’m asking anyone who has been to the first appointment to help me understand the process, as I will be traveling from California. Is all of the testing completed on the first day? If you are from out of the area, can they get all of the results that day? If you are “accepted” after testing, is there a return visit? If so, how soon after the first visit? Has anyone established an ongoing relationship via phone and/or email or must visits always be in person?
Any input would be appreciated so that I can make smart plans.
Thanks so my in advance, and thanks as always to Chaya.
Lynn in California
I too am interested in answers to questions “Lynn in California” asked above. My appointment is March 31. (traveling from Michigan)
Answers would be very helpful. I always have some aprehension of the unknown and liked to be prepared.
Thanks to all who comment and thanks to Chaya….she has given me a wealth of information and I really appreciate this site.
Ali
Hi Ali,
Hopefully someone will respond to us soon. Here’s what I have found out so far, in preparation for my 3/17 appointment:
1) First visit is “applying” to the study and so no expenses are reimbursed. If accepted, then some expenses will be partially covered
2) First visit involves blood draw for CBC type of testing .. may include some metabolic stuff as well, not sure. My understanding is that once accepted (2nd visit) then they do the full FISH, IgVH etc, BMB.
3) After the blood draw you get a physical and then meet with some of the researchers. My understanding is that you can take with you whatever results of that days testing are available and that they will call or send other results on as available.
4) It then takes 4-6 months before you have your “acceptance” visit. I assume they let you know well in advance if you are accepted, but the scheduling takes that long. My understanding is that the CLL study is just one of many sharing the resources (labs, researchers, etc.)
5) There seem to be various shuttles available to/from motels and airports. I’ve chosen to fly into IAD as I am using flyer miles and those were the best flights.
6) I’ve been surfing on the treatment wave, staying just ahead of that moment so hope I will have time for at least a second visit.
So .. actual participants, please consider sharing your experiences with Ali and me, especially any feedback or suggestions for those of us who are traveling thousands of miles for this study.
Thanks in advance for any comments and thanks to Chaya for having suggested this study.
Lynn .. still in California but heading to Bethesda for 3/17 appointment.
My visit to NIH was fantastic. What a wonderful use of our tax $’s. I’ll post more later. Ali, if you want more detail, please send an email to Chaya and she will connect us via email.
Lynn
I would so appreciate hearing more about your experience,LynnS, if you feel comfortable posting your impressions here. I have only just started the application process so any information would be valuable.
Dear qb,
If you don’t mind I can respond to your request. I submitted my application in March 2009 and had my initial appointment yesterday, 5/26/2010. Someone had cancelled and I received an e-mail from Susan Soto asking if I could come in. She sent a letter via e-mail detailing my schedule for the day which started at 11:15 a.m. There was a short wait for each step of the process but it wasn’t excessive. We arrived at NIH about 10:45 a.m. and were finished by 2:30 p.m. My husband went with me and was encouraged to participate. The car and our belongings were searched at the patient entrance and we received visitors ID badges. I registered at admissions where Susan was paged. She met with us, I signed consent papers and she escorted us to the lab pointing out areas of the building we would need to navigate. I had my blood drawn and we grabbed something to eat in one of the cafeterias before my 1 p.m. appointment with the CLL team. A nurse took my vital signs, height and weight. One of the doctors took a history and checked my lymph nodes, liver and spleen. Then a group of doctors came in and thanked me for volunteering for the study and briefly reviewed the purpose and protocol. They discussed the history of my disease with me including the tests results I submitted to them from my private doctor. They said the bone marrow biopsy I had last year was a good one and would not have to be repeated for about three years. I felt reassured my private doctor was taking good care of me. They explained the lab results that were in from that day. I got a copy of them and the others will be mailed to me. I met the criteria for admission into the study and was given a date for my next appointment, February 2011. I have good prognostic indicators and need to be seen only every six months. They will use the tests results from my own doctor visits between visits to NIH so right now it looks like I will be going there once a year. I live in Maryland so travel is not an issue for me anyway. I hope this is helpful. I will be glad to respond to any questions you have.
Pat H.
Thanks so much for replying, birdsfan.
I was immediately struck by the long time frame (over a year!) between your application and initial appointment. I had concerns about travel from one place I stay on the West coast versus one on the East coast, so I see it will be impossible to forecast where I may be IF I get a call to come in. I was interested in the schedule of your day that suggests an overnight stay may be sufficient(keeping costs down).
Did the review of your status reveal anything you had not already been aware of? I would be very happy to get a second opinion on prognostic indicators and assume these would be ‘re-done’ at this time.
Watch and wait is not a thing I do well and CLL/SLL does not lend itself to a feeling of security that we understand what is presently going on and what the future holds. This makes simple facts about this study somehow more comforting and I appreciate knowing what I may expect- at least for one day.
Dear qb,
I received a more detailed explanation of my bone marrow biopsy and feel more comfortable with the “good prognosis” my hematologist/oncologist has given me. Like you, I don’t do well with watch and wait. When I was fist diagnosed in 2008 I couldn’t stop thinking about it and thought I might go crazy before the disease killed me! I am much better now. I take care of myself I haven’t let this thing interfere with my life. CLL Topics is a great help too!
Pat
Dear birdsfan,
CLL Topics has been a godsend in coping with this diagnosis and I have taken citations from here to share with my doctors. And, of course, I would not have been aware of this NIH study without Chaya’s constant surveillance of everything to do with CLL. I would feel truly adrift without her!
I received an email today from Susan Soto with the list of required medical records and description of the purposes of the study. It is encouraging that the clinical trial is still considering applicants! (The study number is now 08-H-0105 since National Heart Lung and Blood Institute took it over.) I live in California; it sounds like there may be assistance with travel expenses, but that travel and hotel for the initial visit must be paid for by the applicant. Can anyone confirm?
Like everyone, I’m deeply grateful to Chaya for making news of this opportunity available.
Michael
I am a participant from California. The deal is: you pay for the first visit entirely. For the second visit, you pay your way out – they pay your way back after you have “signed the forms”. Hotel compensation is only $60 per night and not necessarily for every night YOU thought you needed to be there. So, it will cost you quite a bit, but I think it’s worth it. There are rooms with “NIH Patient rates” but they are hard to come by .. book well in advance and you might get the $99 rate at one of the Marriott’s. I usually have to pay anywhere from $179 to over $200. I’m sure others have found cheaper places to stay, but I seem to be staying mostly at the Bethesda Doubletree as they have really good room service and coming from California, I arrive after the usual dinner hour.
I recommend you go for it, Michael !! The folks at NIH are uniformly wonderful. It’s quite a place: it seems like everyone loves working there.
Lynn
The NIH has had my medical records since May, 2010. I have no idea if they have even been read yet, so don’t know if I am considered ‘qualified’ and on some list for an initial assessment. I take a measure of comfort from posters who report having waited a year for their call but wish there was a way to know where/if I am still in line. Watch and wait…
QB .. Sometimes you gotta be the squeaky wheel to get oiled. I recommend highly that you call Susan Soto and ask where you are in the queue, or email her. I believe their intent is to take everyone .. it just takes time for them to bring in a new participant as well as see those returning. If you call, then you show your interest and perhaps let her know that you could come in case of a cancellation. As far as I know, if you have a diagnosis based on the usual tests, and are not in need of treatment, you will be accepted.
Good luck,
Lynn
LynnS~ Thanks to your encouragement, I did follow up and now have my April appointment. Since I have to travel to Canada in May for my 6 month follow up, it makes a huge difference in cost to fly to NIH from FL instead of Vancouver (as you will appreciate in California) so I am very relieved to have this settled.
QB
Great !! I have a clinic visit on April 1st, myself. If that is your date, look for me in the waiting room .. short bottle-fed red hair and hopeful expression.
Lynn
Completed initial visit yesterday. Great team of people focused on all things CLL. Smart, warm and a great group to have on your side.
Bring a book as there is down time as you shuffle from registration, to lab work, to the clinic etc. They also offer wifi access if you bring a laptop.
When asked how I heard about the study I answered I was a Chayette… they laughed.
Thanks again to CLL Topics for making a difference in my life.
My thanks to Marathon, LynnS, birdsfan and all who have been kind enough to share their experience and advice. Dealing with all the unknowns about CLL is difficult enough, so guidance in managing the practical details of entering this study are a great help. I am particularly heartened to hear so many comments praising the warmth of the staff.
I found that, by simply asking, the hotel I reserved offered a significant unpublished discount for NIH attendees, so hope this may assist other first timers searching for rooms in this very pricey area.
Gratitude most of all to Chaya for making this study known and for maintaining this site to support all of us and help us support each other.
Thanks, everyone, for the extremely helpful and encouraging information about entering this trial. Especial thanks to LynnS for her personal encouragement. I met today with my GP; he’s offered to assemble the required medical records and the bone marrow biopsy. If I get in, I’ll look around the waiting room for a kind person with “short bottle-fed red hair and a hopeful expression”!
Michael
Qb ..
What hotel gave you the good rate? I’m not thrilled with my current Doubletree rate. Thanks in advance .. Let’s all share any practical info we can.
Lynn
LynnS~
I confess I went flight/hotel shopping before getting official paperwork. I didn’t know about the NIH shuttle,or the safety of the area, and simply used Kayak.com & Google to find hotels close to NIH.
The room costs were eye-popping but after research I chose Bethesda Court. I called the front desk directly for best rate (discount sites showed no rooms available) but I didn’t think til end of the process to ask if there was any discount for NIH. That’s when I learned they were on the NIH shuttle and their NIH rate was $159.
Although still pricey for me, I felt it represented good value in that market and this is a smaller, quieter place; I decided to consider it a vacation treat. Curtis (the very personable agent) and I even discussed Florida real estate values (!) which would have been unlikely if dealing with the larger chains. He also said finding Bethesda space later in Spring(I’ll be there April 20th) would be very difficult, so I’ll hope future appointments are ‘off season.’
The official paperwork from NIH does list hotels on their Shuttle route but nothing about special rates so, although embarassing, I am glad I asked. I mentioned the discount to Susan and she was glad to hear of it so perhaps it could be suggested in future mailings.
I am very grateful for all those who have described their experience at NIH and will be glad if this can help someone else.
A couple of comments I would make about NIH. Everyone at the hospital is helpful, so don’t be shy about asking questions and/or suggestions. You have to remember that they have people traveling from all over the country to be there. So, they expect folks to be or feel lost. Let them help.
It took us several trips to figure out the most effecient shuttle to travel to and from the Metro. It might sound silly but we had been there six times before we found out that there are more shuttles going to the Metro on the south of the building than the north side.
One of other patients booked her own flights. But, I found that Omega did a great job and was accomodating to my schedule and the fact that my husband traveled with me. Even though we paid for his tickets they booked them together.
There are goody bags on the 7th floor clinic. They are for the patients so don’t be shy if you are hungry.
The food in the cafeteria is only okay. But, the food at the 3rd floor days hospital was pretty good apparently they have a different kitchen.
I think that is all the helpful hints I have for now.
Good luck!
Karen
Thanks, Karen. Those are just the kind of useful details that really help in a new environment. With all the experience represented on this site, it is possible to create an NIH FAQ for this study.
QB
Great idea to set up a FAQ down the road. For the time being, posts to this topic may be it, if that is ok with Chaya.
Thanks Karen for the cafeteria suggestion. I’d been using the basement cafeteria and it’s grim.
Apheresis:
One of the procedures you may eventually be asked to do is apheresis, which means you are donating lymphocytes for research. It takes about 90 minutes and involves being hooked to a machine that draws blood, puts it through a centrifuge to extract lymphs and then returns the blood in the same line. I had asked Susan for a brochure so I knew what to expect and how to prepare. The brochure had one glitch. Do hydrate well the day before; do not drink too much on the day of the procedure because if you have to pee, your procedure is considered done. Also, don’t eat a fatty meal within 24 hours of the procedure (this is in the brochure) as it will show up in the collection bag.
Travel:
Be aware if you are flying in from a business center to IAD, you are competing with road warriors, especially on United. We had several bad experiences with them: the worst, we were bumped from our non-stop to San Francisco even though we were at the airport three hours ahead. (To top it off, there was a “chest butting” altercation between the United manager who was supposedly helping us and a TSA manager over where the stanchion separating them belonged. Got it on my iPhone.) Anyway, we have decided to now fly Virgin America who seems to have a lot of customer satisfaction. Another tip: make sure you and your visit partner are on the same reservation record. This will keep you together if plane configurations are changed or you are bumped. (Twice that was an issue for us when my husband was traveling on miles and I had a standard reservation.) I chose to book my own travel online and I think that gave me a better rate for my husband, who was not paid for by NIH. A note here .. if you do the “heavy water” NIH study, then a node biopsy is done under sedation AND your travel companion’s fare is paid. I don’t know of any other circumstances where their fare is paid so look for more info from others.
BMB:
Dr. Farooqui, a Fellow on the team, did a great bone marrow biopsy for me. I don’t think I felt a thing other than the initial prick of the numbing injection.
Lodging:
Karen is the expert on this, clearly, for longer visits. For my 3 day stays, I’ve chosen to stay in one of the hotels south of NIH where there are frequent shuttles, restaurants and convenience stores. You have to do a bit of haggle to get a good rate and I’m told by Marriott Residence Inn I will need a letter from NIH saying I’m a patient. There are hotels north of NIH, such as the Marriott Suites, but I’m told there are fewer restaurants and convenience stores there. Also, I understand that the northern shuttle is for NIH employees and goes to the other side (south) of the main patient building, but patients are allowed. (I hope this isn’t too confusing. You can print out a map of the complex from their website and it will be clearer.)
Badges:
(My experience .. yours may differ). I was formally inducted into the trial on my second visit. Once I had received signed papers to that effect from the team, I went to the badge area near the front area. My husband and I then received extended visitor badges. Without these, you must go through security on the driveway into the building. This causes your shuttle to stop and wait for you. With the badge, you flash it and your car or shuttle can bypass the search of your bags etc.
Reimbursement:
I would love for others to post their experience. I submitted a form through the mail (had received via email a form from Susan)and it took forever to get reimbursed and I was never quite clear what had been paid for and what had not. Alison may post on this as she got the process under control and received her reimbursement while at NIH. No taxi’s seemed to be covered even though I arrived at IAD after the NIH shuttle was running. No meals, $60 toward hotel room but not for all the nights I was there etc. My impression is that if you deal in person with the reimbursement people, then you can explain why you had to stay for as many nights as you did. My guess is they don’t really consider time changes, etc., for those of us coming from the West until you talk in person. But I’ll leave it to others to supplement this.
Phew .. hope this is appropriate and that others will share their experiences. NIH is a wonderful place, but first visits can be intimidating. This of course is amplified because none of us is going there for the fun of it. But knowing we are part of a supportive community makes a huge difference.
Lynn, member of the CLL family
If you are able to find appropriate flights at all 3 nearby airports
(IAD,BWI,DCA), is there a reason to prefer one? Traffic patterns, time of arrival, etc….?
Thanks to all our NIH gurus- every bit of information is appreciated.
I always traveled to Reagan National. We stayed in Georgetown at a lady’s home who has worked with my husband for the last 15 years. She graciously offered her basement apartment. I now consider her a wonderful friend. So, I am not the person to ask about hotel stays.
I flew into National because the Metro has a stop there. Tulsa does not have a train system and the bus system is fair at best. Everyone here has a car. My point is that we don’t have any experience using public transportation. But, that is how we get around in DC. It is a very clean system and easy to manuever. We were able to catch the shuttle to the airport to and from NIH a couple of times. That is much easier than dragging around luggage on the Metro. You just have to decide if you want to wait around for the shuttle schedule.
We finally got down a pattern after the third chemo visit. We flew out of Tulsa on Wed morning at 6am. We arrived at National around noon depending on the airline. If we arrived at 11:30 we took the Metro if it was noon, we waited for the shuttle that has two stops 12:20 and 12:30. It takes about 45 minutes to get to NIH from the airport in the shuttle and about the same on the Metro as long as it is running on time. I was supposed to be at the Clinic at 1pm, but was always a little late which didn’t seem to be a problem. The last day of chemo was on Monday. We got to the hospital as close to 8am as we could, got the infusion and took the 9:30 shuttle to the airport.
Karen61~
I had hoped that the Metro would be an easy and faster option from DCA but thinking of luggage and having to switch to a second line, the NIH shuttle is looking much easier even if timing is not the best. How does the shuttle driver validate your right to travel; is it necessary to show something from NIH?
The Metro is fantastic and not at all impossible with luggage. There are alwasy travelers on it. It is however, easier to hop on the shuttle. The driver will either ask you to see your NIH badge or have you sign a log in sheet. Most of the time though, they don’t ask you for anything.
I just can’t tell you wonderful the people at NIH are.
FYI for others considering participating, I applied back in July and am scheduled for my first visit this June.
Thanks to all of you who offered tips about things like NIH hotel rates, goody bags and more. The info is most helpful!
I’ll post a report after my visit this summer.
Qb/Karen/Lynn
Thanks for the info…I will be at NIH for first visit 22 April,
If you are still there look for graying beard reading Kindle.
And I’ll be at NIH April 1 and that’s no joke. So look for the hopeful redhead (very faded right now .. in need of some maintenance, her Kindle and her supportive husband, if you are there for the Friday clinic. This time I’ll have a CT scan. Last time, six months ago, I had a BMB (no pain) and apheresis to share my lymphocytes with their research lab.
I will be at NIH for my initial appointment on April 20th and I don’t have a Kindle….perhaps we should have “Chaya” buttons ;-)
My application in Jan, 2010 got ‘lost’ but I made it onto the list at last in May, 2010 after reaching Susan Soto.
I’m curious. I’ve never had the IgVH mutation test done, even with my two visits to NIH. Has anyone had it done there? I’m going to talk to them about why it hasn’t been done as it seems to be such an important characterization of ones disease. So I would like to see a post from those who have had it done at NIH.
Thanks
Lynn
Lynns:
It might be that they have already done the IGVH gene mutation status test, just not bothered to share the results with you.
On a memorable occasion, when I met Dr. Adrian Wiestner of NIH for the first time, he told me that they often do not share this information with patients because “many of the patients are not able to handle the information”. I asked him how he was able to determine this, did he have a degree in psychology that allowed him to judge which patient is savvy and stable enough to handle the information and which one was not, during the course of a short office visit? And if he made the decision on a purely arbitrary basis, who had elected him god? It is to Adrian’s credit that he took my rather in-your-face approach in stride and invited me to the NIH to speak to the staff on the subject of patients’ rights.
On the other hand, IgVH gene mutation status is an expensive test and may not have been done to save limited funds available.
I was told the mutation test had not been done. I’ve sent an email to Susan Soto cc-ing Drs Wiestner, Mardi and Farooqui asking if it would be done this time and giving them my editorial comment that it would seem an important attribute of my disease and that of others. I also said in that email that I looked forward to hearing more about what data was being collected and how it might be shared with other research institutions. (I feel it’s very important that all of the separate data bases on disease attributes and progression be shared as that provides some empirical basis / support for current and new hypotheses.) I may have just entered the realm of “squeaky patient” but it’s my blood, marrow, body being scanned, time and expense. And it’s my hope that this study is a productive one. I have yet to meet Dr. Wiestner.
LynnS~
Thank you for your pro-active approach. I,too, was concerned on reading the comment elsewhere that NIH did not do IgVH testing as it was data I was counting on getting there. I understand that doctors have interest in IgVH primarily for treatment decisions but, as imperfect as the test may be, it has value to a patient’s understanding of their CLL.
Chaya’s point is confirmed by Dr. Hamblin’s comment from 8/17/2010:
“Although the mutational status of the immunoglobulin variable region (IgVH) genes remains the gold standard for prognostic markers in chronic lymphocytic leukaemia (CLL), it is a complicated assay unsuited to routine laboratories.”
Of course, nothing about NIH is routine.
Dr.Hamblin also noted: “The mutational status of the IgVH genes is fixed in CLL making it unique as a prognostic marker; it assigns cases into one immutable subgroup or the other.”
And in his blog of 6/11/2010 he concludes: “This means that the baseline test that everyone who has full blown CLL should have done – whether or not they want to know the result – is the mutational status of their IgVH genes.”
The cost he quoted in Britain for doing the test was $200 and, if similar to NIH labs, that seems a reasonable ‘perk’ for a volunteer participant.
I look forward to hearing what response you receive.
I am sure there may be concern about patients’ response to their results but that would be true of any data.
Chaya,
A patient on my email list said his expert hem/onc has pooh-poohed the NIH study, saying it’s been done before and is unlikely to yield anything of value. How do we counter that? As Lynn asked, are the NIH researchers sharing their data so others can take advantage of the program? I’m looking for clarity.
Thanks,
Judy
I was told they would be doing IGVH testing when I asked at my initial visit last month. This test was done in my pre NIH days by my local specialist.
While I have only been a club member a short time, seems like too much in life every doc/center has their own agenda/bias so anyone’s pooh-pooh should be taken with a grain of salt.
I was happy to be admitted into the NIH study and for me it has already yielded value; whether that value translates to others in a disease which seems to carry its own profile in each of us and often has little clarity- who knows, but I hope so!
marathon~
As the NIH is my only hope of getting the IgVH test, I am heartened at your report. It is curious that it was an undertaking for the future rather than part of the initial assessment. Was there any discussion of time frame for it?
No, but they joked how they were “a little slower than others” on the diagnostic testing (and I bet part of the reason for that is many folks show up with the tests so they are in essence doing retesting).
All you need to do is ask, they make it very clear they are there to help you!
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