PARTICIPANT: What was striking was the control arm on the 9404. I think it is important to recognize that the control arm in 9404 was about 10 to 12 percentage points worse than the contemporary Dana-Farber stories on which it was based.

DR. ASSELIN: That is right. What I was showing you was the high risk group. So, if you pull that group of patients out, they do do worse. When you look at Dana- Farber, there are standard risk and high risk T cell patients all grouped together. So, that is one reason.

The other thing is to keep in mind that we took a protocol that was very well used within a small group of institutions, and we took it to a big group, and we had to teach over 100 institutions how to do this. That took a lot of teaching and e-mails and phone calls.

TOP