Posted by Becky
We just met with Leif's main local oncologist, Dr. Connelly. She has spoken extensively with the people in Vermont who are involved in the Ibrutinib study. She explained to them that if Leif is going to meet the inclusion criteria, that time will be very short. He needs to be on no more than 20 mg of any steroid, so she will begin tapering Leif's prednisone starting today. His liver numbers are completely fine, so any GVHD is being managed well by the immune suppressants he's taking. And, his platelets need to be at 50. They are now around 10. Platelets are the first blood cells to recover after chemotherapy. He needs to pass the screening labs in Vermont, so the plan is to keep close tabs on his labs here, and as soon as he meets the inclusion criteria, we are jumping in the car and driving at speed to Burlington, where he will re-consent, get screened again, and, if - no, when - he passes, get the medication within 48 hours. Dr. Connelly has asked them to do what they can to have as little time lag as possible within passing the screening and getting the pills.
Leif continues to breathe okay thanks to the Bendamustine he got yesterday and the day before. He's on 3-4 liters of supplemental oxygen, down from 4-5. A noticeable node in his chest is smaller, according to Dr. Benton, Dr. Connelly's partner who is in the hospital on the days she's in Belfast.
He's having a bad pain day today, with pain in his abdomen (probably because his poor spleen keeps growing and shrinking; bad bounts of constipation are not helping there) and back, which often flares up when he can't move around much. He still has quite a bit of edema in his legs and feet as well. Dr. Connelly is prescribing a PCA pump, those lovely machines where patients can self-administer painkiller until they're on top of the pain. Leif is a pro now at knowing what works to get on top of pain and then manage if from there.
A thousand thank-yous to everyone who's putting feelers out about an alternative method of getting Leif some Ibrutinib if he doesn't squeak by the study parameters. What may help is a site that might be slightly more flexible about inclusion/exclusion criteria, or something along those lines. The stress of not knowing whether he will be able to get timely access to this promising drug has been taking its toll on us. Other than the lymphoma, he's still in good shape - young, no complications like diabetes or cardiovascular disease or out-of-control GVHD. He's super methodical and compliant taking his medications, eating healthily and exercising as he's able, and of course he has the legendary Leif tenacity. So I feel like he's a great patient to include in a study.
(Details for people with friends and colleagues in the industry - the drugmaker is Janssen, a subsidiary of Johnson and Johnson. Pharmacyclics did the early drug development. The contract research organization running the study is INC Research, and the local IRB is the Committe on Human Research at the University of Vermont. This is the study, and here is the press release describing its status as an expanded access study.)
We just met with Leif's main local oncologist, Dr. Connelly. She has spoken extensively with the people in Vermont who are involved in the Ibrutinib study. She explained to them that if Leif is going to meet the inclusion criteria, that time will be very short. He needs to be on no more than 20 mg of any steroid, so she will begin tapering Leif's prednisone starting today. His liver numbers are completely fine, so any GVHD is being managed well by the immune suppressants he's taking. And, his platelets need to be at 50. They are now around 10. Platelets are the first blood cells to recover after chemotherapy. He needs to pass the screening labs in Vermont, so the plan is to keep close tabs on his labs here, and as soon as he meets the inclusion criteria, we are jumping in the car and driving at speed to Burlington, where he will re-consent, get screened again, and, if - no, when - he passes, get the medication within 48 hours. Dr. Connelly has asked them to do what they can to have as little time lag as possible within passing the screening and getting the pills.
Leif continues to breathe okay thanks to the Bendamustine he got yesterday and the day before. He's on 3-4 liters of supplemental oxygen, down from 4-5. A noticeable node in his chest is smaller, according to Dr. Benton, Dr. Connelly's partner who is in the hospital on the days she's in Belfast.
He's having a bad pain day today, with pain in his abdomen (probably because his poor spleen keeps growing and shrinking; bad bounts of constipation are not helping there) and back, which often flares up when he can't move around much. He still has quite a bit of edema in his legs and feet as well. Dr. Connelly is prescribing a PCA pump, those lovely machines where patients can self-administer painkiller until they're on top of the pain. Leif is a pro now at knowing what works to get on top of pain and then manage if from there.
A thousand thank-yous to everyone who's putting feelers out about an alternative method of getting Leif some Ibrutinib if he doesn't squeak by the study parameters. What may help is a site that might be slightly more flexible about inclusion/exclusion criteria, or something along those lines. The stress of not knowing whether he will be able to get timely access to this promising drug has been taking its toll on us. Other than the lymphoma, he's still in good shape - young, no complications like diabetes or cardiovascular disease or out-of-control GVHD. He's super methodical and compliant taking his medications, eating healthily and exercising as he's able, and of course he has the legendary Leif tenacity. So I feel like he's a great patient to include in a study.
(Details for people with friends and colleagues in the industry - the drugmaker is Janssen, a subsidiary of Johnson and Johnson. Pharmacyclics did the early drug development. The contract research organization running the study is INC Research, and the local IRB is the Committe on Human Research at the University of Vermont. This is the study, and here is the press release describing its status as an expanded access study.)
Thanks so much for the update, Beck. I am refreshing my browser every hour and praying all the time. Sending much much much much love.
ReplyDeletewill make sacrifice to the lab number gods. take no chances 2 goats and a chicken....
ReplyDeleteOh, how I wish I could magic the drug your way! Hang in there, Leif and Becky!
ReplyDelete