Becoming An Experimental Guinea Pig.

Those who have been following my blog will know that chemotherapy has ceased to work on my lymphoma. In fact shortly after I published my last blog the haematologist officially suspended my treatment. He told me that he was going to investigate what he called a study but perhaps more widely known as a clinical trial. Even though I knew the chemo wasn’t working it still seemed very final having the chemo cut off. After four failed regimes over the last fourteen months I guess I still held out some miraculous hope that the chemo would suddenly become effective.

One of the other issues of having had continuous chemotherapy is that my bone marrow has taken a real kicking. This has resulted in me becoming one of the more regular visitors to the haematology ward at Auckland Hospital. Twice a week while I have my blood extracted and wait for the results I see some others that are having similar issues to me. Often we end up in the same room having a transfusion together. It’s good to know that I am not facing this alone and that there are others experiencing issues along the way. Not that I want others to suffer but there is a sense togetherness.

As the days have gone by since my chemo was suspended I have wondered what sort of study might be applicable to my disease. Looking at Dr. Google opens up thousands of possibilities around the world and one I quickly gave up. Deciding I would just have to wait and see what they came up with. So when the Doctor phoned me on Monday asking Sarah and I to come see him the following day, I was both relieved and apprehensive. Sitting in the waiting room as the time of the appointment came and went, my anxiety continued to grow. I really don’t know why these appointments are always 20 to 30 minutes late. Knowing that without chemo the options are very limited I was very nervous about what was about to be discussed.

I have had the same haematologist for the last five years and his style of dealing with patients is direct but laidback, if that makes sense. We started discussions around the failure of the chemo regime then moving on to details of the proposed study. One thing he took his time to explain is how potential treatment for refractory or relapsed disease is over the next few years likely to become more monotherapy based rather than chemotherapy based. The monotherapy drugs work to block proteins within B Cell lymphoma that prevent the body from recognising the lymphoma as a disease. Once the protein is blocked the body can use it’s natural defenses to attack and kill the lymphoma cells. Or at least that’s the theory. So a similar process to the Car-t cell therapy but without the genetic modification. Packaged in a tablet form it should also be an awful lot cheaper. Hopefully the way of the future.

Currently there is only one similar drug in the world approved in this area and that is Zanubrutinib. This clinical trial is for a drug currently codenamed BGB-11417 with Australia and New Zealand and 284 lucky patients chosen to be guinea pigs for the world. Since this is a brand new drug this will be what’s called a phase one trial where one of goals is to find a safe dosing level. Participants will start with the lowest recommend dose and slowly work up towards what will become the highest recommended dose. No real information is available on side effects as there haven’t been any trials on humans yet and I guess we would be a bit different from the animals they have tested on. A search on Google to find more information brings up numerous links to the trial but almost nothing else. Google does reveal that the company making the drug, BeiGene, is Chinese based with 10 years experience in the industry.

So agreeing to take part in this trial would be a huge step into the unknown. However I guess they choose people like me because what else do I have to lose. Without chemo, which no longer works on me, as an effective medicine to reduce or eliminate the size of my lymph nodes. There is no way of proceeding with the allogeneic transplant or even a normal life. Leaving palliative radiotherapy as the only other treatment option. So it’s almost a case of where do I sign?

Sadly it’s not quite that simple. I still need to qualify for the trail. This involves a number of tests, all of which I have had before and include PET scan, bone marrow biopsy, Lymph biopsy and an Echo cardiogram. The only one that really bothers me is the echo cardiogram given the potential cardiotoxicity of all the chemo I have had. Assuming I pass all these tests then acceptance to the scheme would happen fairly quickly with a potential start maybe six weeks away. Another meeting has been scheduled for four weeks from now to review the tests and discuss my eligibility further. No doubt I will be even more nervous at that one than the first meeting.

The trail would start with 4 days in hospital to ensure that any adverse side effects could easily be dealt with. Also so they can drain me of blood, testing to see how my body is reacting to the process. Once that’s over it’s back to the hospital weekly to start with. Then the time period between visits slowly stretches out to three monthly visits.. The full trial is expected to run for around 18 months. One bonus is that a scan will be performed every 12 weeks to check progress. A good way for me to know how things are progressing in areas that cannot be seen or felt. Although, my pal Fred, who shelters under my collarbone will be a good indicator to start with, since he is rather prominent.

Obviously there is only a limited amount they can cover during the initial meeting, so they give you a 29 page handout that covers most of the major facts. The biggest problem I have found so far is that once the trail is over they will no longer supply the pills. Since approval of this medicine is not expected till 2025 it leaves me wondering what is meant to happen in-between. I did ask if the medicine was seen as curative or a life extender and was told more of an extender at this stage. So if it works maybe the extra time will be worth it, allowing other similar drugs to be approved. If at any stage the disease returns, or fails to respond to the pills, then my participation in the trial would end. It’s also possible that if it does work I might then have the allogenic transplant. I guess we will just have to wait and see. Anyone have a crystal ball?

I would be interested in hearing from others who have taken part in a phase one trial to hear their experience. You can either comment on this post direct, through social media or email me direct at Many thanks in advance if you do contribute.

Published by licencedtoretire

Retired, or at least for now

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