Tuesday, February 14, 2023 4:30:11 PM
Having a crossover rendered no such thing as the protocol in 2013 clearly indicates.
From the 2013 protocol:
Northwest Biotherapeutics, Inc.
DCVax®-L, IND #10206
Protocol: 020221, v5.2EU 30APRIL2013
Study Design:
The study is designed as a randomized, placebo-controlled, double blinded, multi-center,
multinational Phase III clinical trial. To achieve its primary goals, the main arm of the trial will randomize approximately 240 patients with newly diagnosed GBM with no evidence of possible progression at baseline, of which approximately 160 patients will be randomized into the treatment cohort and will receive DCVax-L as adjuvant therapy to standard treatment and approximately 80 patients will be randomized into the placebo cohort and will receive standard treatment supplemented with autologous MNC (placebo).
<snip>
Patients in either cohort who progress during the study will be offered a crossover
(open-label) option with no unblinding to receive a series of up to 10 immunizations with DCVax-L
So I guess the beef is the poorly designed trial by LL and NWBO.
From the 2013 protocol:
Northwest Biotherapeutics, Inc.
DCVax®-L, IND #10206
Protocol: 020221, v5.2EU 30APRIL2013
Study Design:
The study is designed as a randomized, placebo-controlled, double blinded, multi-center,
multinational Phase III clinical trial. To achieve its primary goals, the main arm of the trial will randomize approximately 240 patients with newly diagnosed GBM with no evidence of possible progression at baseline, of which approximately 160 patients will be randomized into the treatment cohort and will receive DCVax-L as adjuvant therapy to standard treatment and approximately 80 patients will be randomized into the placebo cohort and will receive standard treatment supplemented with autologous MNC (placebo).
<snip>
Patients in either cohort who progress during the study will be offered a crossover
(open-label) option with no unblinding to receive a series of up to 10 immunizations with DCVax-L
So I guess the beef is the poorly designed trial by LL and NWBO.
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