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DSMB assessment clears trial without modifications
December 12, 2013
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
The independent Data and Safety Monitoring Board (DSMB) for Celator Pharmaceuticals‘ Phase III trial comparing CPX-351 (cytarabine:daunorubicin) Liposome Injection versus the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3 ) as first-line therapy in older patients with high-risk (secondary) acute myeloid leukemia (AML) has ruled that the trial should continue as planned without any modifications. The DSMB assessment was based on a pre-planned safety...
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