SERENDIPITY

The big news is that as of October 4, 2012 the clinical trial at National Institutes of Health in Bethesda, Maryland (NCT01500733) has been suspended and is currently under review. This research area of the federal government is one of the most valuable resources for people like me who are left with little options. This means that the additional 17p-deleted leukemia patients, who thought they were new participants in the clinical trial, are temporarily on hold and are not allowed to be on the study until further notice. This does not include me, because I am not a new patient.

Professor Chaya Venkat, my patient advocate, met with the research director of Johnson & Johnson to try to get compassionate use of ibrutinib, since these patients will not live long enough for the drug to be FDA approved. She said she would pay her way to California to meet with the drug company stakeholders. She was denied.

It is also unclear whether untreated 17p-deleted patients (me) will be included in the initial FDA approval. The key is to get enough participants in the trial to have a decent enough sample size to warrant inclusion. Suspension of the trial is a big kick in the stomach. We are 5% of the CLL/SLL cancer population.

NIH will continue to follow patients in this trial and continue to provide the drug as long as the drug company provides the drug to NIH. NIH may continue to monitor patients after the trial.

I have written a letter to President Obama letting him know about the importance of the people who provide funding for the research. What is done here at NIH is of incredible value to patients. This is how medicine is suppose to be.

This posting is about my health update.

BLOOD WORK

The good news is that my white blood count (WBC) has dropped another 25,100, which is heading in the right direction. These are normal: electrolytes, kidney, liver, sodium, potassium, red blood count, hemoglobin (which means I am not anemic), and lungs.

These counts I need to keep an eye on:

Lactate dehydrogenase: slightly higher than normal

Uric acid: slightly higher

Platelet function: slightly lower

I have no eosinophils or basophils in my immune system.

Neutriphils are 9.5%, when they should be 34.0% to 71.1%.

BONE MARROW BIOPSY

According to Dr. Adrian Wiestner in the Hemotology Branch of the National Heart, Lung, and Blood Institute (NHLBI) of NIH, I have a very good reduction of malignant B-cells in my body and the experiment is going as expected. My bone marrow biopsy indicates lymphoid infiltration involving 20-30%, as opposed to 40-50% eight weeks earlier. Before the clinical trial, researchers knew that the drug would diminish the size of lymph nodes and eradicate the malignant cells in a patients’ blood through apoptosis (cell death). They were not sure it would help the bone marrow, in which much of the malignant cells hide out. Well, now we have a new scientific finding! It is working on the bone marrow too!

CD3 shows scattered positive T-cells. CD3 is required for T-cell activation.

CD34 protein has slightly increased to 3-5% positive. This is an important adhesion molecule and is required for T-cells to enter the lymph nodes. It facilitates cell migration.

I also have positive megakaryocytes, which are large bone marrow cells from which mature blood platelets originate.

CT SCAN

According to the CT scan, there is a decrease in adenopathy (swelling or abnormal enlargement of the lymph nodes) since June 20, 2012. In the September 7, 2012 report, there is evidence of lymphadenopathy, but the number and size of the lymph nodes on the neck have “dramatically decreased” when compared to several months prior.

The CT scan indicated degenerative disease in my neck of which I was aware. Prior to beginning the clinical trial, I was going to physical therapy at The Barrow Institute in Scottsdale. The attending physician had looked at my scans and thought he had pulled the wrong medical records when I entered his office. He said that if he had just looked at the medical scans, he would have said that I was a patient who had to immediately go in for spinal surgery. He said he was surprised at how good I looked. Surprise! But this is another story for another day…

MORE GOOD NEWS

In spite of the fact that I have had some minor side effects, such as slight bruising, a little dizziness, and occasional tenderness in my mouth, I have no breathing problems, no high blood pressure, no appetite issues, no mouth ulcers. I have had a little more fatigue the past cycle (even though my blood work does not indicate a reason for the fatigue). I think I was so excited that I was feeling better that I overdid it a little.

FINAL THOUGHTS

The researchers at NIH are pleased with my progress on this experimental drug. It seems to be doing what it is supposed to do. I am about as happy as an “egg-suckin’ dog in the middle of a chicken coop” (my husband Carl’s words).

One thing I understand is that even when my WBC is normalized (between 4,000 to 10,000). I will still be immune compromised since the drug does not cure me. It simply manages the cancer. Medicines that interferes negatively with Ibrutinib are the following: anti-fungal systemic pills, anti-depression medicine, acid reflux medicine, and blood thinners (a BIG no-no).

Being immune compromised also means that I cannot ever have inoculations with live viruses, such as a live shingle shot. I also cannot be around people who have had the live virus shot for about a week to 10 days. That also includes live virus inoculations given to my grandchildren, my dog, and people at the Walgreens Pharmacy.

When you are first diagnosed, you should have a pneumonia shot, which should last about five years. A flu shot should be given every year, even though it may not help a patient who has had leukemia for a while, but it might help a little.

Since the number one cause of death for patients like me is pneumonia, the herd mentality is in place here. If you have been inoculated and protected from whatever diseases and you are in good health, flock around me, because you will protect me from the germy people. LOL.

I personally will be eternally grateful for the opportunity I have been given to participate in the NIH clinical trial with Ibrutinib (PCI-32765), regardless of whether this experimental drug helps me in the long haul or regardless of whether I continue to have access to it. I know I am helping others in the future, who can benefit from the findings of this scientific research.