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Alert Number 119

A Turbocharged Clinical Trial: FCR+M

Date: August 11, 2005

In the past couple of days we have issued two Topics Alerts (# 117 and # 118) on the subject of the new clinical trial at M. D. Anderson, a combination of FCR+M + Neulasta (the addition of mitoxantrone to their previously tested combination of fludarabine, cyclophosphamide and Rituxan, with Neulasta to mediate expected neutropenia). MDA is the only center recruiting patients for this clinical trial at this point. I promised you I would dig into this a bit more, give you more details on the risks and rewards associated with this turbo-charged combination.

We have just published a full length article, Mitoxantrone plus RFC, discussing the details of this trial. We raise some important and troubling questions that you should think about before you participate in this clinical trial, or for that matter, any early phase clinical trial.

We have contacted Dr. Stefan Faderl of M. D. Anderson who is listed as the Principal Investigator for this clinical trial, as well as OSI pharmaceutical (the company sponsoring this trial: they market Novantrone, their brand name for mitoxantrone), and we are waiting to get their responses to our questions. We will be sure to publish their responses as well, when we get them.

In the meantime, we advise you to discuss these issues in detail with your doctors, before you decide to participate in this clinical trial and start therapy.

Be well,


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