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Posted by Frederick Wasti
Nov 30 2012

This week (on Monday) I started Part C of my clinical trial. The most obvious transition has been in scheduling -- unlike Part B, where we had to go to Dana-Farber in Boston three days each week, for each and every week of the past five months, we now have to go to D-F only once every two weeks. The difference between those two schedules is huge.

In Part C, I am supposedly now in a "maintenance" mode (or, at least, that is the hope). I am still receiving the same two monoclonal antibodies, at the same dosages, that I was given during Part B, but I am just receiving them much less often.

In Part C, I will be given Alemtuzumab each time I "visit" D-F, which means I will receive it (by injection) only once every two weeks, which contrasts sharply with Part B, where I was given Alemtuzumab three times per week, every week. Similarly, in Part C, I will be given Ofatumumab (by infusion) only once every two months, which contrasts with Part B, where I was given Ofatumumab once each month. (This further contrasts with Part A, where I received Ofatumumab once every week.)

Basically, Part A used Ofatumumab and high-dose Methylprednisolone to chase CLL B-lymphocytes (and, unfortunately, healthy B-lymphocytes, too) out of the lymph nodes and spleen, where they are harder to kill, and into the blood stream, where they can be more effectively attacked. The strategy in Part B was to concentrate on killing B-lymphocytes "at the source", in the bone marrow (with, unfortunately, even greater "collateral damage", since Alemtuzumab kills not only healthy and leukemic B-lymphocytes, it also kills T-lymphocytes as well).

The idea behind the "reduced" intensity maintenance protocol in Part C is this: Now that my CLL has been greatly reduced, to such a low level that it is difficult to find evidence of it, I will continue to use the same antibodies against it, and at the same dosages, but I will do so much less frequently.

I've been "beaten up" every week since last March with a fairly intense series of chemicals being "poured" into my body, but the chemicals ~have~ done their job, reducing my CLL to a very low level. To continue to beat me up further at this point would not make any sense: First, I don't think my body would be happy with taking much more of the level of medication it has been getting in either Part A or Part B. And, second, since my CLL has now been reduced to an almost undetectable level, it would also be difficult to demonstrate that continuing intense treatment was even doing any good at all.

Officially, Part B was supposed to last for six months. However, for me it lasted "only" five months. The good news is that my CLL was reduced to an almost undetectable level about a month early, and so the decision for me to be graduated to Part C likely involved the thinking that it would be difficult to justify continuing an "extra" month of abuse when it could not even be shown that it was actually doing anything productive.

However, simply stopping treatment altogether would not be a good strategy, either. Although the level of my CLL is indeed very low right now, it is ~not~ zero -- there is no simple "cure" for CLL. There are still zillions of leukemic B-lymphocytes in my body, ready to grow back in number if/when they are given the chance, and they might do so more rapidly than anyone would want -- because of the 17p deletion in my CLL cells, they have lost the normal ability to undergo apoptosis (i.e., "natural cell death"), which is to say that they just don't know how to die on their own.

In a way, Part C's protocol reminds me a bit of "Goldilocks and the Three Bears" -- Goldilocks didn't want to eat porridge that was too hot or too cold - she ate up only the bowl of porridge that was "just right" (probably while sitting on the chair that was neither too hard nor too soft but "just right", etc.). Well, hopefully Part C will be "just right" for me right now -- I will be receiving the same (obviously effective) monoclonal antibodies that clobbered my CLL in Parts A and B, but much less often, hopefully still frequently enough to keep my CLL in check, but also seldom enough to allow my body to heal and return to the vicinity of normalcy.

So, that's the plan for now -- just grin and "bear" it... (<grin>)

Categories: Leukemia