Community Magazine

ASCO 2014: Dr. Susan O'Brien Outlines Open Trials of Novel Agents and Equipoise in Trial Design for CLL (chronic Lymphocytic Leukemia)

By Bkoffman
In the third part of my interview at ASCO 2014, Dr. O'Brien points out the advantages of being in a clinical trial, including the real financial advantages of getting the trial drug for free. However do remember that the standard of care of drugs such as rituximab are not free. The labs and imaging are not usually free.

The one exemption are trials at the NIH where all costs are paid by our tax dollars. This is is the only way that most of those with no insurance or from out of country can afford  to be in a  clinical study.

Some of the active trials Dr. O'Brien asks us to consider is the phase 1 trial of the very promising second generation BTK inhibitor, ACP-196 that seems to be more selective and has longer binding. Nothing published yet, the early buzz is positive

TG Therapeutics has its next generation anti CD-20 monoclonal antibody and its PI3K inhibitor combined in a promising trial.

The CLL arm of trial of "Ublituximab + Ibrutinib in Select B-cell Malignancies" is already closed.

There is an ibrutinib versus ibrutinib plus rituximab trial at MD Anderson for relapsed patients. Free ibruinib!

The list keeps growing. Please check out clinicaltrials.gov when you are considering therapy. We need more options and the only way we get them is through trials, and the only way trials happen is if patients enroll (and their doctors recommend them).

Finally Dr. O'Brien eloquently addresses the issue of equipoise in clinical trials. This ASCO post article from 2013 should be mandatory reading for all patients and all trialists. Please listen carefully to all that she has to say, and how these breakthrough medication have changed how we should design future research. There are lives in the balance.
I love her blunt talk: "They will have to allow cross-overs."
Here is Dr. O'Brien. Again, my apologies for the poor audio quality.
If you haven't heard the prior two sections of the interview, please check them out.
Big news here in the next day or two.If you want a personal response, or just want to stay in touch, please email me at [email protected]. I have no other way of contacting. Thanks. Stay strong. After all, we are all in this together.

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