As promised, here is the latest information on the PCI-32765 clinical trial at the NIH. Given the importance of this trial, I will ask Radha (our webmaster) if there is some way we can have a special tab on the homepage where our members can access the latest information, read the discussions and comments readily.
The citation for the trial on clinicaltrials.gov is up. Click on the link to access all the detailed information regarding inclusion criteria etc. Cross-checking with the information I posted in my previous article I did not notice any discrepancies. But while I try to be as accurate as I can, please remember the last word is theirs, not mine.
Notice the comment right on top of the trial announcement, saying “This study is not yet open for participant recruitment“. I hear that will change as soon as staff get back from their New Year vacations. Please allow me to emphasize once again, I believe this trial will finish recruitment very quickly. The actual process of getting patients in to Bethesda MD for pre-assessment etc may take some time. So, I am afraid it is going to be a bit of hurry up and wait (what else is new in life, right?).
- Be sure to read all the details of the clinicaltrials.gov citation, as well as our review articles on PCI-32765 articles (CAL-101 too, after all it too is a member of the kinase inhibitor drugs). You can find the articles by typing in the appropriate key word or phrase into the search box at the top right hind side of our homepage.
- If after due consideration you decide you fulfill the inclusion criteria, and further more, you are seriously interested in participating in this trial, that is when it is appropriate for you to contact them.
- Please don’t jam their phone lines or overload their email system with irrelevant questions at this time. The time and resources you waste will cost another patient who may really need access to this technology. We have to watch out for each other.
- Once you have your interest in participating on their record, the next step is the hardest: be patient. I expect they will get an avalanche of queries from patients and it will take a little time for them to sort through all the mail. I am afraid I am partly to blame for the huge interest. Just Google “PCI-32765 clinical trials” . My recent article is very high on the citation list of Google, no small achievement. And we do have an awful lot of devoted readers of this website.
- You can bet on it that I will be keeping close watch on this trial. You can do your bit by adding your voice to the discussion section. We can learn a whole lot more when we work together.
Site News
- I have managed (barely!) to keep up the rate of publication of new articles, about one every week. There are 154 different articles now on the Updates website. You can browse through them at your leisure, or as the topic becomes a hot button issue for you. I hope to continue at about the same rate in the coming new year.
- Our membership is huge and keeps increasing, with no sign of leveling off. In the month of December, even with all the holidays and stuff, we had more than 45,000 visitors to the website. No wonder Google picks up our citations so quickly (and drug companies sit up and take notice) when we publish new review articles.
- I plan on conducting at least two workshops in 2012. Both will be held in Columbia, MD. I am afraid I do not have the man-power resources to plan for (and financial resources to pay for!) workshops conducted elsewhere. Dates and topics of the workshops will be announced at a later date. Our rented conference hall holds about 50 people. We register ahead of time, and try to accommodate as many people as we can. Our previous workshops (“All about prognostic indicators” and “Everything you wanted to know about FCR“) were very well received.
- My email traffic continues to grow. All the same, this one-on-one contact I have with our members is probably the best part of my “job”. So, please continue to write to me. You can get my email address by clicking on the “Feedback / Contact us” button. I promise to get back to you in a day or two at most. (Social emails may take a bit longer).
- Phone consultations have to be limited to when I am in the USA – calling India is a little expensive, the time zone difference is a hassle etc. If you wish to see me in person, please write ahead of time and set up a time and date that works for both of us.
- As always, there is no fee charged for any of the services we provide.
- I have been invited to speak again at the CLL 2012 conference in Niagara Falls, Canada. I guess I did not do so badly the last time, since they asked me to come back for a second time. I am looking forward to it since it gives me a chance to meet many of you. The organizers had videotaped the presentations the last time – here is the link to the YouTube video of my presentation.
22 comments on "PCI-32765 trial at the NIH – Update"
Consider yourself supported and validated, Chaya! No group of individuals, no matter how pressing their challenge, can do a good job of facing it without leadership such as yours.
I am not at the stage where a chemo intervention is merited(crossing my fingers and knocking on wood!)but I know that these new regimens are my best chance of a normal life span, which is always good to have!
My best wishes for the New Year!
Thank you, Chaya. Your patient advocacy is a blessing.
Wishing you all good things in the New Year.
— La Verne
Although we don’t chat much. I am so glad we have you as an inspiration and guide to muddle us through our CLL issues. I sure wish we could speed up the whole darn process of bringing drugs to market, but our bureaucracy of clowns in Washington DC don’t have any clue about how real people have to deal with real life issues. Keep up the great work and godspeed to you and your family.
First,, Wishing you, Chaya, and all who are dear to you good health and strength and peace in 2012.
In no small measure of thanks to you, I can enter a new year in better shape than I would have been. So for that, your continued guidance, and education is vital to many of us I thank you.
A couple of thoughts on this new trial. NIH trials, done AT NIH, may be different, and that this is not a drug company sponsored trial, may also make this trial truly closer to cost free, unlike others. That would certainly help some who might otherwise be unable to participate. While it’s true that every state has different regulations regarding what insurance, including medicare must cover during a trial, this can get sticky if one leaves their own state for a trial.
PCI is a pill which may require fewer trips to Bethesda, however, others have found that with cal101 and pci trials, if side effects do arise, and a trip back is requested or desirable it’s not always easy to accomplish. The difficulty in this case arises when the patient requires hospitalization away from the trial location and the problem is deemed due to the trial drug, insurance has sometimes objected. Aside from that however, it’s unlikely the problem would be addressed as quickly or diagnosed correctly away from the site since there’s little to no familiarity with the drug. In a few cases of ‘lung’ problems the patients were taken off or down on the drug. While pills make some things easier, they remove the physician, and a physical exam from the formula, making good thorough testing even more important. Good communication with the trial coordinator is crucial here… and This is where strong self advocacy and forewarning helps. Even a moderately nagging cough should be dealt with immediately when on these drugs. regardless of the cause. If patients do this trial from a distance, establishing a relationship with a local hematologist, oncologist to follow them would be a good thing as well.
I share your cudos on the design of this trial, and your concerns about the ‘side effects’ of these drugs, since there were scant specifics given at trial end. And the lack of knowledge concerning marrow condition prior or post is disturbing. That is indeed a shame. Since everything else about this trial is dotted and crossed, we can hope that patients will comply with the ‘extra’ requests and have their marrow tested and the CT’s done. IF the other trials had done that and shown good results in those areas, I suspect this one would fill up in no time. Without that however, as patients it’s makes putting this as a first choice in any of the segments offered more tricky, save perhaps the 17p’s.
Yes, the heavy water was done at LIJ, under Dr. Rai. I participated in that. The only ‘inconvenience’ was getting the scheduled blood draws done since my access to local blood draws was a little convoluted, but I did manage and LIJ sent me Fed Ex, pre addressed envelopes to use. There were no side effects. Also, if one is flying home from the trial site you may want to have them ship the ‘box’ of heavy water….first, it’s heavy, and secondly, not sure what airport xray might do to the ‘water’. or if they’d even let you on the plane with it. I’ve found differences in airports when it comes to medications in general, over the 3oz etc. NY was fine, but Minneapolis required a pat down. citing my ‘medications’ as a reason. It may depend on the individual TSA agent one gets.
Thanks Chaya, for everything. Beth
Dear Chaya –
This time of year I count my blessings and update my gratitude list. Please know Chaya that you hold a place of prominence on my gratitude list. Words are inadequate to fully express the appreciation I feel (and that you deserve) for your very special (and unique) contribution to the entire CLL community.
You are one of the good souls that help to make this a better world. May 2012 bring you and your family many blessings and much joy.
Regards – Patti
Thanks, Chaya, for all the very informative updates.
Wishing you the very best in the New Year.
Monique
Thank you Chaya for the updates. This is indeed good news.
Thank you for your fantastic work.
Your love and devotin to P.C. Vankat is incommensurable.
He is proud of you.
Best wishes for 2012.
Chaya,
Best wishes in the new year. Maybe we will reconnect in Niagara Falls.
Stay strong
Brian
Just gratitude for your articles, which I forward to an appreciative haematologist: he claims to learn a lot, also from following various links indicated. Also grateful thanks for keeping me sane; happy New Year, Godt Nytt AAr from Mette
Adding my thanks for all you do for the CLL community.
Yes your wonderful lucid explanations are a real help. The vibe of this whole site it right on.
I participated in an NIH trial for low dose Rituxin several years ago and liked the way it was handled, despite the fact that it did not work for me. I was reimbursed for most of my travel expenses by NIH
Happy New Year to Y’All
Chaya, you and your Family are our knights in shining armour, thanks so much for fighting for us.
I’m traveling back to the US this week to discuss this trial and the Natural History with the goal of entering one at that time. I’m having periodic night sweats and platelets in the low 100’s or high 90’s depending on the day. I also have a p53 mutation so Dr. Farooqui said they would take a CBC, exam and then we can discuss which way to go. He said one would have to meet the IWCLL criteria for treatment despite the fact it is not explicity published on the trial inclusion criteria. I’ll write more after the meeting.
My husband signed the consent forms for the PCI-32765 trial but it was to be conducted in Columbus Ohio. The trial, I believe has begun. We were waiting to hear from the trial coordinator so we could make our plans to head to Columbus, but we received a call last week stating that he was not qualified for the trial. For safety reasons, they decided not to include any patients with Richters in this current study. It was a heartbreaking call, but we are looking for other trials now.
I recently met with the NIH CLL team and will sign into this protocol along with the heavy water study in late Feb/early March.
Here are a few of the pertinent details:
I’m 33 with a p53 mutation, unmutated IGVH, low platelets around 100 and most recently, mild to severe night sweats depending on the night.
I agreed to every request including a CT, pre/post BMB, lymph node excision and core need biopsy (some related to heavy water; some to to PCI)
Study should meet its recruitment goal of 64 sometime late this year (between August and December I would say) and I’m number 4 so far.
Monitoring will occur on day 1 and 2 of PCI, day 14, day 28 and every 28 days later until the end of cycle 6 (one cycle is 28 days). From there, you continue if the drug works and the company is still in business although there is mention of a possible 3 month break at the end of the study. I’m not clear on that point right now. Honestly, I don’t think they’ve thought that far out about it yet. It sounds like some of the monitoring can be done from home later into the protocol.
I asked if finding out how the drug affects the marrow is a primary point to the study and he said no, but it would be useful information as a secondary objective.
I gathered all the information requested for the study and mailed it to the nurse at NIH. My local hem/onc feels my W/W is over with a white count doubling time over the past year from 14k to 73k and IGGs in the 400s. NIH will interview me there but the doctor does not think I will qualify for the trial because he feels I am not yet in NEED of therapy. He wants me to consider the other two trials…natural history and heavy water. So, back to square one. I thought I was a pretty good candidate, but maybe not.
Franc .. getting into the Natural History study is the first and very important step. Once you are in that, they will take very good care of you. Your doubling time probably does not meet the IWCLL 2008 guidelines for treatment, which I’m sure they have to follow RELIGIOUSLY. So join the study .. you will be so happy if you do. I am in at and know I have wonderful docs watching my back.
Thanks, Lynn. I have spent a lot of time looking into both of the trials, and seriously considering them…and you just gave me the boot I needed.
Chaya, first let me thank you again, with all the thousands of other CLL patients and caregivers, for your relentless advocacy on our part, and your ability to translate complicated medical journal articles for us lay people. If it were not for you, I would not have learned about the CLL Consortium and been able to have my husband become a patient of Dr. Kanti Rai. (A wonderful, caring human being, whom we consult yearly and who takes the time to discuss treatment options for my husband with our local oncologist in upstate NY)
My husband was diagnosed in 2005 (unmutated, 13q deletion, Zap 70 +) and his WBC escalated to over 300,000 in 2009 at which point he began FCR treatment. At that time I contacted the wonderful Dr. Terry Hamblin in England, whom I am sure you know has recently succumbed to another form of cancer. Dr. Tamblin spent years after retirement responding to questions from CLL patients all over the world. At the time my husband began FCR, I contacted you for advice and you were adamant about his need for allopurinal before treatment because he had lost a kidney due to kidney cancer in 2005 and because of the risk for Tumor Lysis Syndrome. At the same time, Dr.Tamblin advised that my husband be on prophylactic Bactrim, aclyovir (Valtrex), and something called Voriconazole. I spoke to both our local oncologist and Dr. Rai about the recommendations–somehow something got lost in the mix with another local doctor before chemotherapy began, and my husband was not put on Valtrex. As a result (possibly, and only in my opinion) several months after his six rounds of chemotherapy, he developed a severe case of shingles in his leg, which resulted in his femoral (?) nerve being completely, although temporarily, destroyed. It took him two years (his remission period, unfortunately!) to recover from this horrible shingles bout. He still suffers from post-herpetic neuralgia. I can’t emphasize enough the importance of prophylatic Valtrex or a similar anti-viral while patients are undergoing chemotherapy. I will never forgive myself for not being more proactive about Dr. Hamblin’s advice when my husband began chemotherapy.
I digress. After an almost two year remission after FCR (albeit with the shingles forcing him to walk with crutches and undergo pain due to shingles worse than anything he suffered previously), my husband relapsed and is again in need of chemotherapy. I use the word relapsed since he had a good year and a half of relative good health despite the shingles–therefore I think his current situation is relapsed rather than refractory. After consultation with both Dr. Rai and our local oncologist, he has begun a new chemotherapy regime with Bendamustine and Rituxan. His WBC count is coming down but his platelet count is disturbing–although still at 39,000. Our major concern at this time is ongoing, persistent sinusitus–I guess to be expected with the immune system deficiencies he has. He is also receving IVIG treatments monthly, and Neulasta after his chemotherapy.
I keep returning to something you wrote in your article, “Life After FCR.” I quote: “In general, patients who have relapsed after FCR have few good options. Salvage therapy is not all that effective and remissions are short lived. With the exception of mini-allo transplant, the survival statistics for post FCR relapse patients are bleak at best.”
Which brings me, in this long post, to ask a relatively quick question. It seems to me from reading your articales that kinase-inhibitors bring the cll cells out of the marrow into the bloodstream where they can be “attacked” by the kinase inhibitors. The new trial of PCI-32765 seems tailor-made for my husband who has a high tumor load. In addition, we are extremely motivated to contribute to any research regarding familial CLL for our children’s sake as well as the CLL community. My husband has the 17 p deletion (a change in FISH results, within the past two years) and at 62 I think would be eligible. I will contact Angelica and Dr. Rai at LIJH to see if perhaps the Bendamustine and Rituxan should be discontinued in favor or him possibly entering the study, although only 64 will be admitted. He has already participated in Dr. Rai’s heavy water clinical trial.
Perhaps it’s too late and/or not feasible, but once again, I want to thank you for the wealth of information we can access on your website. If you or your daughter ever need help with basic web-related help, I am a retired teacher with a speciality in computer technology, and would love to offer volunteer services.
katmcgrat6:
I am so sorry to hear about your husband’s bout of shingles – especially since it is quite preventable – most of the time – with appropriate anti-viral prophylaxsis. But it is now water under the bridge.
You correctly point out the difference between a FCR “relapsed” versus “refractory” patient. The quote for “Life after FCR” is a bleak one and is applicable to patients who are refractory, i.e., who relapsed soon after FCR therapy. There is no hard and fast rule on how long is too soon. Typically, anyone who gets a less than two years after completion of FCR and need for initiating new therapy has cause to worry.
With the new FISH status of 17p deletion, the frequent infections, I have little doubt your husband would be eligible for the PCI-32765 trial at the NIH. But the best way of confirming that is to talk to the researchers at the NIH directly. I am pretty sure there are still quite a few slots open, especially for 17p deleted folks. I am also pretty sure they would want your husband to discontinue all other therapy for a “wash-out” period – typically one or more months – before he can start on the PCI-32765.
All in all, this is not an easy situation and the best advice I can give you is to consult with the experts – Dr. Rai and the folks at the NIH – in order to reach a decision. Once again, thanks for highlighting the need for shingles prophylaxsis for at-risk patients before undergoing high impact chemotherapy.
IBRUTINIB is our new name for PCI32765. Sounds plausible and inline with Bruton Kinase Inhibitor.
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