Dr. O’Brien Outlines Open Clinical Trials of Novel Agents and Equipoise in Trial Design for CLL

In the third part of my interview at ASCO 2014, Dr. O’Brien points out the advantages of participating in clinical trials, including the real financial advantages of getting the trial drug for free. However do remember that the “standard of care” drugs such as rituximab may not be  not free. The labs and imaging are not usually free. The one exemption are clinical trials at the NIH where all costs are paid by our tax dollars. This is the only way that most of those with no insurance or from outside the US 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 ublituximab and its PI3K inhibitor TGR-1202 combined in a promising trial. The CLL arm of the 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 ibrutinib!

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 addressed the issue of equipoise in clinical trials. This ASCO post article from 2013 should be mandatory reading for all patients and all those who design or conduct clinical trials. Please listen carefully to all that she has to say, and how these breakthrough medications have changed how we should design future research. There are lives in the balance.

I love her blunt talk: “They will have to allow crossovers.”

And the good news is that recently nearly all new trials have a crossover built-in from the start.

Here is Dr. O’Brien. Again, my apologies for the poor audio quality.

Brian Koffman 12/3/14