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Saturday, June 27, 2020 7:57:44 AM
If they progressed (or pseudo-progressed) during that 3 months, they were not randomised into the main trial, but were entered into the information arm, so they still got DCVax treatment.
At first they were entered into the information arm, 54, including 4 without enough product to receive more than a few DCVaxL vaccines. Then in 2014 they created a secondary trial for patients who had progressed (or pseudo progressed) within that 3 month period before receiving their first vaccine of DCVaxL.
I have always been curious how they will use this secondary clinical trial. They expected as many as 99. We’ve never heard a word sbout this group. Some of them may have been pseudoprogressors from the chemorad. It was open label, so no doubt the management andDr. Liau had access to their progress.
Could this group be used as a basis for approval for rGBM?
If some did exceptionally well, would they have examined them for pseudo progression?
Will they be used in some context to support the main trial, particularly if they find pseudoprogressors that surpassed 5 years?
Are there “like Brad” patients in this secondary trial that will help support approval?
I know this trial is not part of the main trial, but they had a plan for it. Otherwise, they would not have created a clinical trial for these patients. And we know that info outside the trial can be used to support an approval.
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