Wow, looked at my last post, and there is a lot to update. It has been a crazy week.
Last you all heard, I had barely made the study requirements, and we sent the blood to the independent testing lab and hoped that they would come up with the same numbers. By the time I needed to set off for Burlington, there still was no word on the lab test. So, with fingers crossed, off we went.
We had reached Farmington when I got the phone call. The study coordinator, Hannah, called to say that the liver enzyme number tested at 86! I am IN. Well within the study parameters. You can imagine the relief. It was such a good feeling to finally be out of this limbo and be getting treatment with a very promissing drug. On top of that, the drive out was just beautiful. Rt 2 winds through the mountains and the leaves were just about perfect. My good friend Liza was acting as my temporary caretaker for this trip, and we had a great time driving through the scenery, and looking forward to a pretty decent indian resteraunt in Burlington for dinner.
Not long after, Kate - my primary nurse coordinator from Dartmouth Hitchcock called to make sure that I knew the news, that Dr Sprague (the Doctor running the Ibrutinib study) had called Dr. Meehan (my primary hemo/oncologist) and that I was good to go.
At 4:30, about two hours out from Burlington, I got a phone-call from Dr. Sprague. He called to let me know that there was a problem. The study director - the Doctor that oversees the study for the company that makes Ibrutinib was concerned that I still had Graft vs Host Disease (GvHD). That by itself was not the problem, but the drug that one uses to treat GvHD, Prednisone, is restricted in the study. They allow a dose of 15mg, but I am on a dose of 140mg.
I pointed out that we knew this and had talked about it. On the day that I enter the study, I have to take 15 mg, and then the study allows for up to 10 days of a higher dose. The plan, I reminded Dr. Sprague, was that I get into the study, and then we return my dose to 70 mg. My liver enzyme numbers show a pretty clear trend that we will have successfully treated the GvHD with about another 4 days of treatment, and that I likely will not need any further Prednisone at all.
Statically though, it usually takes 6 weeks of treatment of Prednisone to cure GvHD. It is just a fluke that I respond dramatically. The study director was not buying the idea that I could possible get over the GvHD within the 10 days. And if I did not, I would be out of the study. Furthermore, I would have no possibility of being able to get BACK in the study if I had to be dropped. From his point of view, it would commit resources to a patient that clearly was going to be dropped, it would be bad for study, and it would be bad for me. There is a pretty short list of drugs that you should not be on if you are on Ibrutinib, and Prednisone is one of them.
I asked Dr. Sprague to show the Study director my numbers, talk with Dr. Meehan about how quickly I have responded to the drug before, and show that while on average it does take 60 days, in my personal case, that was highly unlikely. The most likely scenario is that by the time I started taking the drug on Thursday, my GvHD would probably already be in control (as that was 3 days from when I had my last blood draw). He agreed to call the Study director again and argue my case.
I called Dr. Meehan and gave him a heads up. I wanted to make sure that Dr. Sprague gained confidence that, in my specific case, the GvHD was going to be a non-problem.
At 5:45, Dr. Sprague called back. (We are still on the road to Burlington, about 45 minutes out at this point). He had talked to the Study director again, and the final answer was NO. The study director was NOT going to let me into the study at this point. I was going to be allowed into the study with another blood test only after I had been on 15mg of Prednisone or less for at least 5 days. That is to say, I had to prove that my GvHD was under control before I entered the study. I was upset, but in reality, this was not unreasonable. I claimed that it would be under control with 5 days, and they wanted me to prove that this was the case. This would set back my treatment by just a week - everyone would have confidence going forward, and the I would not be subject to whatever risk there is with the combination of Ibrutinib and Prednisone.
Still, I must say that I was pretty disappointed. The problem with this fairly reasonably request is that I have not had any treatment since my DLI, and my lymphoma is especially aggressive. I am having problems with plural effusion (fluid in my lung), and Dr. Meehan and I are not confident that I have an extra week before I have SOME sort of treatment. It is not like the Ibrutinib is magic - any treatment takes a while to kick in. We also want some wiggle room for a Plan B in the event that the Ibrutinib had no effect on me. I really should have started some sort of treatment 2 weeks ago, the first time that I was in Burlington. I talked to Dr Sprague for some time to see if there were any other options, to see if I could convince him to pressure the study director into moving forward anyway. I pointed out that this is not a Phase III trial, but an access trial. That is to say, a method of getting the drug to patients almost SPECIFICALLY in my situation. He felt that he had pushed his limit with the study director, and that nothing good would come out of trying to badger him into accepting me into the study.
So... after sitting by the side of the road for a bit, we decided to go ahead to Burlington. We had reservation at Hope Lodge (which is a wonderful place - I will get around to describing it at some point), and we were still looking forward to dinner at the indian restaurant. Furthermore, even though my meeting for the Ibrutinib study was canceled, I wanted to see Hannah, and thank her for the work that she put in, talk about the possibiblity of getting into the study in a few months after I had some other treatment, and I also scheduled a thoracentesis (draining my lungs), which I desperately needed.
The indian food was pretty good, although not really worth a 6 hour drive in of itself. :)
Leif
Last you all heard, I had barely made the study requirements, and we sent the blood to the independent testing lab and hoped that they would come up with the same numbers. By the time I needed to set off for Burlington, there still was no word on the lab test. So, with fingers crossed, off we went.
We had reached Farmington when I got the phone call. The study coordinator, Hannah, called to say that the liver enzyme number tested at 86! I am IN. Well within the study parameters. You can imagine the relief. It was such a good feeling to finally be out of this limbo and be getting treatment with a very promissing drug. On top of that, the drive out was just beautiful. Rt 2 winds through the mountains and the leaves were just about perfect. My good friend Liza was acting as my temporary caretaker for this trip, and we had a great time driving through the scenery, and looking forward to a pretty decent indian resteraunt in Burlington for dinner.
Not long after, Kate - my primary nurse coordinator from Dartmouth Hitchcock called to make sure that I knew the news, that Dr Sprague (the Doctor running the Ibrutinib study) had called Dr. Meehan (my primary hemo/oncologist) and that I was good to go.
At 4:30, about two hours out from Burlington, I got a phone-call from Dr. Sprague. He called to let me know that there was a problem. The study director - the Doctor that oversees the study for the company that makes Ibrutinib was concerned that I still had Graft vs Host Disease (GvHD). That by itself was not the problem, but the drug that one uses to treat GvHD, Prednisone, is restricted in the study. They allow a dose of 15mg, but I am on a dose of 140mg.
I pointed out that we knew this and had talked about it. On the day that I enter the study, I have to take 15 mg, and then the study allows for up to 10 days of a higher dose. The plan, I reminded Dr. Sprague, was that I get into the study, and then we return my dose to 70 mg. My liver enzyme numbers show a pretty clear trend that we will have successfully treated the GvHD with about another 4 days of treatment, and that I likely will not need any further Prednisone at all.
Statically though, it usually takes 6 weeks of treatment of Prednisone to cure GvHD. It is just a fluke that I respond dramatically. The study director was not buying the idea that I could possible get over the GvHD within the 10 days. And if I did not, I would be out of the study. Furthermore, I would have no possibility of being able to get BACK in the study if I had to be dropped. From his point of view, it would commit resources to a patient that clearly was going to be dropped, it would be bad for study, and it would be bad for me. There is a pretty short list of drugs that you should not be on if you are on Ibrutinib, and Prednisone is one of them.
I asked Dr. Sprague to show the Study director my numbers, talk with Dr. Meehan about how quickly I have responded to the drug before, and show that while on average it does take 60 days, in my personal case, that was highly unlikely. The most likely scenario is that by the time I started taking the drug on Thursday, my GvHD would probably already be in control (as that was 3 days from when I had my last blood draw). He agreed to call the Study director again and argue my case.
I called Dr. Meehan and gave him a heads up. I wanted to make sure that Dr. Sprague gained confidence that, in my specific case, the GvHD was going to be a non-problem.
At 5:45, Dr. Sprague called back. (We are still on the road to Burlington, about 45 minutes out at this point). He had talked to the Study director again, and the final answer was NO. The study director was NOT going to let me into the study at this point. I was going to be allowed into the study with another blood test only after I had been on 15mg of Prednisone or less for at least 5 days. That is to say, I had to prove that my GvHD was under control before I entered the study. I was upset, but in reality, this was not unreasonable. I claimed that it would be under control with 5 days, and they wanted me to prove that this was the case. This would set back my treatment by just a week - everyone would have confidence going forward, and the I would not be subject to whatever risk there is with the combination of Ibrutinib and Prednisone.
Still, I must say that I was pretty disappointed. The problem with this fairly reasonably request is that I have not had any treatment since my DLI, and my lymphoma is especially aggressive. I am having problems with plural effusion (fluid in my lung), and Dr. Meehan and I are not confident that I have an extra week before I have SOME sort of treatment. It is not like the Ibrutinib is magic - any treatment takes a while to kick in. We also want some wiggle room for a Plan B in the event that the Ibrutinib had no effect on me. I really should have started some sort of treatment 2 weeks ago, the first time that I was in Burlington. I talked to Dr Sprague for some time to see if there were any other options, to see if I could convince him to pressure the study director into moving forward anyway. I pointed out that this is not a Phase III trial, but an access trial. That is to say, a method of getting the drug to patients almost SPECIFICALLY in my situation. He felt that he had pushed his limit with the study director, and that nothing good would come out of trying to badger him into accepting me into the study.
So... after sitting by the side of the road for a bit, we decided to go ahead to Burlington. We had reservation at Hope Lodge (which is a wonderful place - I will get around to describing it at some point), and we were still looking forward to dinner at the indian restaurant. Furthermore, even though my meeting for the Ibrutinib study was canceled, I wanted to see Hannah, and thank her for the work that she put in, talk about the possibiblity of getting into the study in a few months after I had some other treatment, and I also scheduled a thoracentesis (draining my lungs), which I desperately needed.
The indian food was pretty good, although not really worth a 6 hour drive in of itself. :)
Leif
No comments:
Post a Comment