*Backdated Post*
*Some content copied from Facebook Posts*
I completed the cycle 3 of reduced intensity Decitibine + Venetoclax on March 10 and I went back to meet with Dr. Bixby on March 15. They hadn't been planning to do a bone marrow biopsy at that time, but due to the fact that my good blood counts weren't recovering at the expected rate they decided last minute to go ahead and do one. Always fun to find out last minute that you're having that procedure done especially on top of finding out something was probably wrong.
At the appointment we discussed our hopes that my marrow was just tired and sluggish from all the chemo and that we would be able to plan to either go to Houston for transplant (if biopsy showed remission) or for another cycle of Decitibine+venetoclax if I still wasnt quite in remission. But we also discussed the negative what ifs. That he would give me the option of a clinical trial or another type of chemo (more on these in FB posts copied below).
During my appointment we talked about how well I had tolerated the reduced intensity Decitibine + Venetoclax and how I hadnt gotten any fevers or infections. Then I ended up with a fever later that night and ended up going to the hospital at 3am. I got admitted and started on IV antibiotics but all my cultures came back negative for infection so they sent me home on the 19th so that I could make my clinic appointment with Dr. Bixby on the 20th.
Once we got back all the results and decided to go with the clinical trial I got set up to do my pre-tests on March 27 and start the trial on April 10.
Mar 18:
I feel like I only get bad news lately.
One month ago I had just barely 1% residual leukemia keeping me from getting a transplant. They asked me to do another round of chemotherapy in hopes of beating that last bit out. Unfortunately it had a reverse effect, and my biopsy Friday showed almost 7% leukemia now.
They are sending me home from the hospital tomorrow and I see my doctor again Wednesday. There is an option of a potential clinical trial, but I'm not sure how I feel about it. We are going to call MD Anderson to see their thoughts on the trial UofM is recommending vs other potential options.
Mar 20:
This is a really long update so grab your reading glasses and get comfy...
So today we went back to UofM to meet with Dr. Bixby and get the final results of my biopsy from last Friday and discuss next steps.
The final results were 6.5% blasts and we also learned that the biopsy at MD Anderson last month was actually 5% not 1%, so this result is "within the realm of stable". However, my blood counts are still not recovering or stable. For this reason he is definitely recommending that we NOT repeat a 4th cycle of the Decitibine and Venetoclax which I have been on since November.
At this point he said that I have pretty much exhausted all but one clinically approved drug for treating AML, which is called MYLOTARG and which is yet another IV chemotherapy. It is a very harsh chemo that would guaranteed tank all of my counts again and also has risks like blood clots in the liver. There is an increased risk of these clots if I move on to get a transplant afterwards, and doing this drug could even make them more hesitant to even do the transplant on the future. It is also a one-shot remission drug. Which means that if I take it and it reduces the blast percentage but doesnt fully put me in remission, we cant do a second round in hopes of further reduction. This is the absolute last ditch FDA approved chemotherapy that I can try before reaching a point of hearing "I'm sorry but there is nothing else we can do"
The other option that is being offered to me is a fairly early stage clinical trial. I still have to be accepted into the trial before this can officially become an option but my doctor is almost certain that I will be approved. The trial drug doesnt even have a name yet it is so new, currently it is just going by the code name DS-3201b. They have not released any information on whether the current study participants have benefitted from this drug or not, so it's kind of a total shot in the dark.
The way the first phase of the study works is that they bring people on in waves of 3-6 participants at a time. The first group of people got 100mg of the drug. This is called cohort 1. After a month if no serious side effects are seen they recruit 3-6 more people which they give 200mg of the drug for cohort 2. And they continue on upping the dose by 100mg each time until they reach a point where they think they have found the maximum effective dosage. Once you are in the study though, you stay at your original dosage. So a cohort 1 participant would never be able to move up to 600mg even if that was found to be the most effective dose.
If I join the study I will be part of cohort 5, which means I will get a 500mg dosage of the drug. My doctor said he believes most cohorts so far only had the minimum of 3 people, so I am in all likelihood one of the first 15-20 humans in the world to take this drug. I would be the first person at UofM to join the study.
My doctor favors me joining the study now, vs moving on to the MYLOTARG chemo for multiple reasons.
1) The timing just happens to line up that my current chemo failed and the study is open for accepting the 3-6 new patients for cohort 5. If I go for another treatment option now, this trial may not be open in the future. But if I do the trial now, the MYLOTARG will be there as an option if this doesn't work, if i choose MYLOTARG now, I may not be able to get into the trial later.
2) in addition to clinical trials in humans the company is also doing laboratory tests of the drug where they test it against different subtypes of leukemia and in different dosages. Just TEN days ago they sent my doctor an email letting him know that in the laboratory testing they are seeing a higher rate of response to the drug in leukemia that has an MLL rearrangement mutation, which is what I have. Currently there are no other drugs or trials which lean towards having an advantage for this mutation. If anything the MLL rearrangement generally shows LESS response to almost all drugs on the market compared to other AML subtypes.
3) this drug is given outpatient as a pill, and isnt expected to tank good counts as bad as traditional chemo (although my counts are currently super low already and the drug will still likely affect them more).
Based on all of this information I agreed today to start the process of finding out if I qualify for the trial. This will take some time and I will have to have a bunch of tests done like ANOTHER bone marrow biopsy, 3 EKGs, and tests on my liver and kidney function. If approved it will probably be about 10-14 days from now before I would start the drug.
Once I start the drug there is a lot of monitoring involved including some days where I have to sit at the clinic for 8-10 hours to get my blood drawn every hour after taking the pill to see how my body is metabolizing it. There are also frequent repeats on the bone marrow biopsy, EKG, and liver/kidney tests. These frequent checks are another thing that helped me decide to participate in the trial. If at any point the results show that the drug isnt helping or my blasts increase on the repeat biopsy or if I feel like the side effects are too much I can quit the trial. Pretty much i can decide to quit at any time for any reason.
So that's the latest and (not so) greatest. I should know by the end of the week my potential start date and then get all the testing scheduled from there to see if I'm approved. Thanks for reading.
