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Biotech / Medical : CLTR COULTER PHARMACEUTICAL

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To: Gordon James who wrote (410)12/2/1999 12:07:00 AM
From: Bob L  Read Replies (2) of 666
 
There's a new article on Zevalin: Phase I/II Trial of IDEC-Y2B8 Radioimmunotherapy for Treatment of Relapsed or Refractory CD20+ B-Cell Non-Hodgkin's Lymphoma, Journal of Clinical Oncology, Vol 17, Issue 12 (December), 1999: 3793-3803. Available full text online via free trial at jco.org. (I believe the free trial expires at the end of 1999).

I would of course be interested in anybody's comments on this. I've only had a chance to glance at the article, but I noticed this line: "A significant correlation was noted between percent bone marrow involvement with NHL at baseline and hematologic toxicity." Overall, the toxicity didn't look that much different from Bexxar. As you pointed out, Gordon, it really shouldn't since both set up maximum doses based on hematologic toxicity. If it isn't toxic, give 'em some more.

This phase II study used dosimetry with 111In as usual with Zevalin. A couple of us have speculated that dosimetry is being used in the trial but clinical application will not require it. I now suspect I didn't know what I was talking about when I said that. I went back and looked at the phase III protocol and it also uses dosimetry. How are they going to get clinical approval without dosimetry when the phase III used it?
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