CAL-101 Personal Experience / Phase I Study
The other day I was reading about the first published results of the CAL-101 Phase I Study which my husband is enrolled in. The article is "CAL-101 Update: half full glass." As I was reading, I realized I had some answers to some of the questions posed (based on personal experience) and thought it might be helpful for me to comment on my blog. My remarks are never intended as medical advice. But I have benefited (as a patient advocate for my husband and mother-in-law) from the sharing of other patients' personal experiences. And I consider it my personal responsibility to share our experiences for the benefit of others.
Background Info (in case this is your first time reading):
My husband entered the CAL-101 study for previously treated/relapsed and refractory patients after receiving no remission from Rituxan alone and then six rounds of FCR (+ experimental Lumiliximab). The hope was that Lumiliximab would enhance FCR and result in a longer remission. The addition of Lumi did not produce those results and that trial was discontinued. But FCR has been the Gold Standard CLL treatment for quite a while and Dr. Flinn's expectation was that John would get a decent remission from it. He was diagnosed in 2007 and his biggest issue was bothersome bulky lymph nodes throughout his body. He would not have required treatment if not for his lymph nodes. His WBC was high for a normal person, but not that high for someone with CLL. And his only symptom other than lymphodenopathy was fatigue (which was tolerable).
John sailed through his first infusion of Rituxan without suffering any of the potential reactions. But when we left, he passed out cold in the elevator from tumor lysis syndrome. With the help of other people in the elevator, I got him back in the doctor's office waiting room where he passed out a second time (sitting down this time). This was one of the scariest moments (perhaps THE scariest moment) of our entire CLL journey. I really thought I was losing him the second time he lost consciousness. But he revived quickly and started making jokes to Dr. Flinn the minute he came to. We practically flew John (Dr. Flinn, the attending nurse and myself) by wheelchair to the ER. He was monitored for several hours and was just fine. So the weekly Rituxan infusions were continued. Unfortunately, Rituxan only worked on his blood and did not produce any lasting relief from the lymph nodes.
The next year John tolerated the swelling, occasionally taking small doses of prednisone for temporary relief. We were trying to avoid chemotherapy for as long as possible. I had read about all the possible risks and side effects (toxicity, damage to his immune system) and even the possibility of transformations from treatment. I was not gung-ho to do FCR and I knew that while it produced great remissions for some, there was no guarantee. When John decided he wanted to have this treatment, I tried to be as upbeat and positive as possible. But I knew there was a chance he could subject his body to that toxicity and not get results.
While he did get some reduction of the nodes during the six months of chemotherapy, they did not completely shrink and they began swelling again within two months of the last infusion. That was a pretty discouraging time. He had failed the Gold Standard CLL treatment. Now stem cell transplant was on the table. (And to say I was not excited about this option would be an understatement.) I had done a lot of researching, investigating and reading personal experiences. I knew SCT was not a magic bullet. Yes, there are some exciting success stories. But there are some very serious complications and risks that can greatly reduce quality of life. And sometimes patients die from complications of the transplant itself. After John's very disappointing lack of response to FCR, I didn't have the highest of hopes that he would be one of the great success stories. (I am not a pessimist, but definitely a realist when it comes to treatment choices. Since John was first diagnosed, I have taken the responsibility for doing the research and learning necessary to make sure John at least makes informed decisions.)
It was around that same time that I was starting to read about a new drug called CAL-101. I had made a CLL friend online (CLL Christian Friends) who also had the struggle John had with lymphodenopathy. He was actually in worse shape than John. He had relapsed from previous treatments and was told (if I'm remembering correctly) that he probably would not see the end of 2011. He was facing the probability of stem cell transplant being his only hope when he was accepted into the CAL-101 Phase I Study at OSU. And immediately after starting CAL-101, he began improving and getting relief from not only the lymph nodes but from the severe fatigue that had necessitated his early retirement from a job he loved. This friend (also in his fifties) was sharing about his dramatic results on CLL Christian Friends. And he even took the time to email me and share his very honest opinion about transplant. He strongly urged me to pursue getting John into the CAL-101 trial and provided me with contact numbers and other info.
I wasn't sure if Dr. Flinn was participating in the same trial. I knew he was involved in CAL-101 clinical trials as combination therapy (with Rituxan and chemotherapy drugs). But my gut feeling was that John should do CAL-101 alone. He had already received Rituxan twice without benefit. And he had just failed chemo. So why infuse drugs into him that we already knew had not proven helpful to him? I ask lots of questions and express my own opinions at our visits with Dr. Flinn. It's never bothered him. He answers my questions thoroughly and never makes me feel like I'm taking up too much of his time. I've cried in the exam room and we've also had a lot of laughs. I have never met a better doctor and I love his staff. So I didn't want to go anywhere else. But I was willing to go anywhere if it meant John being able to try CAL-101 alone. Before our next appt. with Dr. Flinn, I had an appt. lined up at OSU with Dr. Byrd (just in case CAL-101 alone was not an option with Dr. Flinn). I can't stress strongly enough, I had no desire to be in the care of anyone other than Dr. Flinn. We love Dr. Flinn. But I felt that John should try CAL-101 before considering transplant.
At our next appt., I brought up the CAL-101 trial with Dr. Flinn and told him I had contacted Dr. Byrd's office just in case we needed to travel to get John in it. He said that he was participating in the same trial and, if that's what we wanted to do, he would try to get John enrolled. We waited about three weeks and finally received word of his acceptance into the trial. Right after he was enrolled, this trial was closed to new CLL patients. I did not know (until reading the initial findings published on CLL Topics) that there were only 54 patients enrolled in this study. John started CAL-101 (May 2010) at the lowest dose (50 mg. twice a day) and has gotten excellent results with -- so far -- no toxicity or side effects. I am aware that this dose doesn't work for every patient. But it has for him. CAL-101 has been a miracle drug for John so far.
Currently:
Other than still battling some fatigue as the day progresses, John has no symptoms. He has made adjustments (like coming home earlier), but he still works six days a week unless we go out of town. And he is back to running on the treadmill regularly. His lymph nodes started to reduce within days of his first dose. (We saw a difference after the first day.) They continued to shrink to almost normal size and have remained stable ever since. He is now in the rollover phase of the study (after completing the first 12 cycles) and will continue on CAL-101 as long as it keeps working.
Details relating to the trial results:
Marian is fully recovered (after two weeks in the hospital, including three nights in ICU) and is doing well. She says she feels great and is back to her normal routine. (She is a very vibrant and youthful 78!) Dr. Flinn took her off CAL-101 until her pneumonia ordeal was over. I think she missed about three weeks of medication. And she resumed CAL-101 at a reduced dose of 100 mg. (twice daily). At her last visit, it appears that the 100 mg. dose is not working quite as well as 150 mg. Her WBC has started to increase again. Her next evaluation is at the end of June and I will give an update on her status at that time.
For any CLL patients reading this, please feel free to ask me any questions you may have either here in the comment section or by private email. My email address is ShariLHowerton@aol.com. I am always more than happy to communicate with other CLL patients and caregivers. I enjoy hearing from readers!
As always, I hope this information is helpful to someone.
Background Info (in case this is your first time reading):
My husband entered the CAL-101 study for previously treated/relapsed and refractory patients after receiving no remission from Rituxan alone and then six rounds of FCR (+ experimental Lumiliximab). The hope was that Lumiliximab would enhance FCR and result in a longer remission. The addition of Lumi did not produce those results and that trial was discontinued. But FCR has been the Gold Standard CLL treatment for quite a while and Dr. Flinn's expectation was that John would get a decent remission from it. He was diagnosed in 2007 and his biggest issue was bothersome bulky lymph nodes throughout his body. He would not have required treatment if not for his lymph nodes. His WBC was high for a normal person, but not that high for someone with CLL. And his only symptom other than lymphodenopathy was fatigue (which was tolerable).
John sailed through his first infusion of Rituxan without suffering any of the potential reactions. But when we left, he passed out cold in the elevator from tumor lysis syndrome. With the help of other people in the elevator, I got him back in the doctor's office waiting room where he passed out a second time (sitting down this time). This was one of the scariest moments (perhaps THE scariest moment) of our entire CLL journey. I really thought I was losing him the second time he lost consciousness. But he revived quickly and started making jokes to Dr. Flinn the minute he came to. We practically flew John (Dr. Flinn, the attending nurse and myself) by wheelchair to the ER. He was monitored for several hours and was just fine. So the weekly Rituxan infusions were continued. Unfortunately, Rituxan only worked on his blood and did not produce any lasting relief from the lymph nodes.
The next year John tolerated the swelling, occasionally taking small doses of prednisone for temporary relief. We were trying to avoid chemotherapy for as long as possible. I had read about all the possible risks and side effects (toxicity, damage to his immune system) and even the possibility of transformations from treatment. I was not gung-ho to do FCR and I knew that while it produced great remissions for some, there was no guarantee. When John decided he wanted to have this treatment, I tried to be as upbeat and positive as possible. But I knew there was a chance he could subject his body to that toxicity and not get results.
While he did get some reduction of the nodes during the six months of chemotherapy, they did not completely shrink and they began swelling again within two months of the last infusion. That was a pretty discouraging time. He had failed the Gold Standard CLL treatment. Now stem cell transplant was on the table. (And to say I was not excited about this option would be an understatement.) I had done a lot of researching, investigating and reading personal experiences. I knew SCT was not a magic bullet. Yes, there are some exciting success stories. But there are some very serious complications and risks that can greatly reduce quality of life. And sometimes patients die from complications of the transplant itself. After John's very disappointing lack of response to FCR, I didn't have the highest of hopes that he would be one of the great success stories. (I am not a pessimist, but definitely a realist when it comes to treatment choices. Since John was first diagnosed, I have taken the responsibility for doing the research and learning necessary to make sure John at least makes informed decisions.)
It was around that same time that I was starting to read about a new drug called CAL-101. I had made a CLL friend online (CLL Christian Friends) who also had the struggle John had with lymphodenopathy. He was actually in worse shape than John. He had relapsed from previous treatments and was told (if I'm remembering correctly) that he probably would not see the end of 2011. He was facing the probability of stem cell transplant being his only hope when he was accepted into the CAL-101 Phase I Study at OSU. And immediately after starting CAL-101, he began improving and getting relief from not only the lymph nodes but from the severe fatigue that had necessitated his early retirement from a job he loved. This friend (also in his fifties) was sharing about his dramatic results on CLL Christian Friends. And he even took the time to email me and share his very honest opinion about transplant. He strongly urged me to pursue getting John into the CAL-101 trial and provided me with contact numbers and other info.
I wasn't sure if Dr. Flinn was participating in the same trial. I knew he was involved in CAL-101 clinical trials as combination therapy (with Rituxan and chemotherapy drugs). But my gut feeling was that John should do CAL-101 alone. He had already received Rituxan twice without benefit. And he had just failed chemo. So why infuse drugs into him that we already knew had not proven helpful to him? I ask lots of questions and express my own opinions at our visits with Dr. Flinn. It's never bothered him. He answers my questions thoroughly and never makes me feel like I'm taking up too much of his time. I've cried in the exam room and we've also had a lot of laughs. I have never met a better doctor and I love his staff. So I didn't want to go anywhere else. But I was willing to go anywhere if it meant John being able to try CAL-101 alone. Before our next appt. with Dr. Flinn, I had an appt. lined up at OSU with Dr. Byrd (just in case CAL-101 alone was not an option with Dr. Flinn). I can't stress strongly enough, I had no desire to be in the care of anyone other than Dr. Flinn. We love Dr. Flinn. But I felt that John should try CAL-101 before considering transplant.
At our next appt., I brought up the CAL-101 trial with Dr. Flinn and told him I had contacted Dr. Byrd's office just in case we needed to travel to get John in it. He said that he was participating in the same trial and, if that's what we wanted to do, he would try to get John enrolled. We waited about three weeks and finally received word of his acceptance into the trial. Right after he was enrolled, this trial was closed to new CLL patients. I did not know (until reading the initial findings published on CLL Topics) that there were only 54 patients enrolled in this study. John started CAL-101 (May 2010) at the lowest dose (50 mg. twice a day) and has gotten excellent results with -- so far -- no toxicity or side effects. I am aware that this dose doesn't work for every patient. But it has for him. CAL-101 has been a miracle drug for John so far.
Currently:
Other than still battling some fatigue as the day progresses, John has no symptoms. He has made adjustments (like coming home earlier), but he still works six days a week unless we go out of town. And he is back to running on the treadmill regularly. His lymph nodes started to reduce within days of his first dose. (We saw a difference after the first day.) They continued to shrink to almost normal size and have remained stable ever since. He is now in the rollover phase of the study (after completing the first 12 cycles) and will continue on CAL-101 as long as it keeps working.
Details relating to the trial results:
- The median age of the study group is 62. John turned 57 in March. He was diagnosed at 53.
- Some of the other patients in this study have been more heavily treated than John.
- John does not have the 17p deletion. He has all good markers with the exception of being unmutated (which is considered a poor prognostic marker).
- John never experienced the rise in white count that many patients initially have on CAL-101.
- John has not had a subsequent bone marrow biopsy, but at the beginning of the study his bone marrow was only 20% infiltrated. (My mother-in-law is in another CAL-101 study in combination with Rituxan. She is 78 years old and was previously untreated. Her bone marrow was 80-90% infiltrated at the beginning of treatment and a recent BMB showed that her marrow infiltration has been reduced to 30% after the first six cycles. Since there was no mention of bone marrow status in the abstract cited by CLL Topics, I thought this might be useful information to share.)
Marian is fully recovered (after two weeks in the hospital, including three nights in ICU) and is doing well. She says she feels great and is back to her normal routine. (She is a very vibrant and youthful 78!) Dr. Flinn took her off CAL-101 until her pneumonia ordeal was over. I think she missed about three weeks of medication. And she resumed CAL-101 at a reduced dose of 100 mg. (twice daily). At her last visit, it appears that the 100 mg. dose is not working quite as well as 150 mg. Her WBC has started to increase again. Her next evaluation is at the end of June and I will give an update on her status at that time.
For any CLL patients reading this, please feel free to ask me any questions you may have either here in the comment section or by private email. My email address is ShariLHowerton@aol.com. I am always more than happy to communicate with other CLL patients and caregivers. I enjoy hearing from readers!
As always, I hope this information is helpful to someone.
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