CAL-101: Day 43

John continues to do well. His white count is only up to 10.2 (high normal range) after being on CAL-101 since May 27. His neck looks wonderfully thin again. (I think I forget what he actually looks like without the nodes!)

He is still tired and doesn't feel as good as he would like to, but we think that has a lot to do with stress. His reflux has also been pretty intense lately (even with medicine).

John had to sign a new consent this morning because of some changes in the clinical trial protocol. There is new information on toxicity and patients have to be updated and informed as new information about the drug is learned. As we were going through the explanation of that, the trial coordinator shared some of the findings of the trial thus far. After this conversation, I understood certain things better than I had previously.

The study has shown that CAL-101 seems to have a higher toxicity (in the liver) for CLL patients (at higher doses) than for lymphoma patients. And the drug is working even better for lymphoma patients than CLL patients. In John's case, his CLL "behaves" more like a lymphoma than a leukemia, even though it is clinically CLL. This is probably one of the reasons he is doing so well on CAL-101.

One down side of CAL-101 (in CLL) is that it tends to increase the patient's white count pretty dramatically. Eventually, this levels out. But because most CLL patients needing treatment already have a high white count; raising it even more creates issues for some. This is why they are also studying CAL-101 in combination with other drugs (like Rituxan and Treanda) for CLL patients. The additional drugs work on the white count and counter the unwanted effects of CAL-101 on the blood. As this was being explained, I felt like pieces were being added to the puzzle for me.

When I first learned of this trial, I wanted John to have the opportunity to try CAL-101 as single agent because he had just gone through chemo, had not gotten good results, and had not even had the chance to fully recover from the toxicity of the treatment he'd completed in January. I didn't want him to get more chemo so soon. Since CAL-101 is showing such great results in the lymph nodes, I was eager to try it. But I was not thrilled at the prospect of more chemo.

Because there are different arms of this trial and the others are studying combination therapy, I wasn't sure if John could get CAL-101 alone. You have to conform to the trial. In the previous trial, John did not have input into which arm he would be in. One arm was standard FCR and the other arm was FCR plus Lumiliximab. Selection was done randomly by computer. I didn't know if John would get to choose an arm of this trial. And I felt frustrated at the possibility that John might have to receive other (more toxic) drugs in addition to CAL-101 to participate. I didn't fully understand the reasoning behind that. And I was ready to advocate that we travel to another state if we could do CAL-101 alone somewhere else (with another specialist). Not that I would ever want to leave Dr. Flinn. We would continue under his general care. But I was willing to go anywhere to avoid more chemo. After discussing it with Dr. Flinn back in April, my mind was relieved to know we could try CAL-101 as single agent under Dr. Flinn's care. He just had to get John a spot in the trial. But he said he was 99% sure that he could do that within 30 days, which he did.

What we didn't know at the time is that the window would be closing soon on that arm of the trial.

The recent findings are leading the researchers to the conclusion that CAL-101 works better in CLL in combination therapy than alone. And, after today's discussion, I think I understand this better. Combining CAL-101 with the other drugs (that work better on the blood) would obviously help keep the white count under control as well as attacking the disease in the lymph nodes. And in combination with the other drugs, I assume they give CAL-101 at a lower dose, reducing toxicity.

So, from this point on, "they" (whomever dictates protocol) have made the decision not to enroll any more CLL patients into the trial with CAL-101 alone. All future CLL patients participating in this trial will get either CAL-101 in combination with Rituxan or Treanda. But those who are already enrolled will continue with their current protocol. John seems to have gotten in just under the wire.

The increased toxicity seems to be at doses of 100 mg. or greater. However, some patients have suffered no toxicity at doses as high as 300 mg. CLL patients have a lot of variation in their disease and their response to treatments. John is on the lowest dose (50 mg.) and has not shown any liver toxicity in his blood work so far. His nodes have responded dramatically and he has not had the dramatic rise in his white count that we were told could happen (and usually does). Although there are no guarantees as to how long he will get these fantastic results, the response so far couldn't be much better. Which leads me to the conclusion that he is responding like a lymphoma patient and does not need those other drugs. At least not now.

I understand that these trials are for the purpose of learning what works best for the most patients; at what dosages and with the least toxicity. There will always be patients who deviate from the norm. FCR achieves a lengthy remission for most patients. It did not get even a partial remission for John. CAL-101 alone is working for John and I'm so thankful he had the opportunity to try it without additional drugs.

A friend and I were talking today about how God sometimes answers prayers in ways that don't completely meet our hopes or expectations. We might not get exactly what we're praying for, but if we look for the positives that came out of even our disappointments and losses, they are always there. God brings good out of everything; even tragedies. And sometimes many of our prayers ARE answered through a different outcome than what we had asked for. We were in agreement that the only way to get through these disappointments is to trust Him and know that, even when we cannot understand His ways, He has a purpose and a plan for our lives.

What gives me peace is knowing that He is in control, and He knows what is best more than I do. I don't struggle with a need to understand or have every question answered. I might ask, "Why?" but I really don't expect Him to explain every detail of His plan to me.

When John failed chemo, I was VERY disappointed. I was even a little distraught. I was definitely scared. I felt the return of fear and anxiety like I hadn't experienced since those early months following diagnosis.

My prayer had been that John would get a complete remission and then hold the record for the longest remission in CLL history. (I wasn't asking for much. LOL.) I KNOW God heals. I KNOW God is powerful enough to eradicate CLL from John's body any time He wants to. I KNOW God hears all of my prayers. And I KNOW that God loves John and loves me. After all, it was God's love and mercy that brought us together in the first place. God has nothing to prove to me. I can look back over my life and see His hand again and again. He has protected me, guided me, delivered me, redeemed my life in more ways that I could have even dreamed possible. And He has blessed me so far beyond anything I could have ever deserved. It is I who owe Him.

Therefore, I was deeply disappointed, but not angry. And because I knew that God could have changed the outcome, I accepted that it must have been His will . . . for whatever reason. I had peace even though I was afraid and disappointed.

Now, just a few months down the road, I see how John could not have gotten into this arm of this clinical trial except within a narrow window of time. A clinical trial can last five years or more before a drug receives FDA approval and is on the market. If this drug continues working for John, he will continue receiving it now that he's enrolled in the study.

I don't know what is going to happen tomorrow. And if another disappointment comes, we will face it with God's grace. But at this point in time, I am so thankful for this silver lining and the answered prayers that have come through a completely different outcome than I could have envisioned.

When our journey first began, I prayed that John would have the most benign CLL and all good markers. God did not answer that prayer according to my will. Instead, God spoke to my heart and told me not to put my faith in the markers or even a specific outcome, but to put my faith in HIM and in His promise that He is working all things for our good; even this. I have reflected on that afternoon in 2007 so many times since. And, by His grace, that is what I will always try to do.


Anonymous said…
Whatever you and John need from me then you have it. I don't care what time or what it is. I love you!

Shari said…
It means so much to know you are there for me whenever I need you, Jennifer. I love you too.

I feel very optimistic that CAL-101 will continue working for John. It is amazing to see his neck go back to what it was before CLL.
Anonymous said…
I'm glad he's doing better. I wish you and your family God's blessing.
- mychoice
Shari said…
How nice to hear from you MC. Thank you, and I wish the same for you and yours. Take care.
Jan F. said…
Shari, I have been following John's progress thru your blog. I also have CLL (diagnosed in 12-08) and it seems I have more node involvement than blood. I am so excited for you and John that CAL 101 is working so well with little side effects. I am still in the wait & watch mode but one day may be facing treatment and it nice to know there is something new on the horizon. I admire your faith in God and isn't it amazing how He orchestrates everything just in time! I just lost my husband on June 1 from kidney cancer so now I am trying to concentrate own my own CLL. May God continue to heal John's body and give you strength as a caregiver. Jan F./Texas
Shari said…
Jan, thank you for your nice comments. I am so sorry to hear about the loss of your husband.

I hope you have a very long watch and wait and those nodes behave better than John's. But it certainly is helpful and encouraging to read and learn about new treatments that are working for others, no matter where we are in our own personal journey. I have done extensive reading on CLL and CLL research ever since John's diagnosis in June 2007. That is one of the reasons I share a lot about John's experiences on my blog. Even if it's only emotional or spiritual encouragement that a reader receives, I feel like I might be helping someone and not even know it by sharing the details.

I would have been writing about CLL from the moment we received this diagnosis. But John was very private about his health issues in the beginning. He has opened up a lot over the last couple of years and gave me official permission last summer to blog whatever I wanted. (I must confess, I asked for his permission in the middle of a kidney stone ordeal and he was a little loopy. But there was no going back.)