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Hana Biosciences Begins ALL Trial

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Hana Biosciences initiated a multi-center Phase II trial of Marqibo in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). This study is designed to support a Phase III trial of Marqibo for the treatment of ALL.

The Phase II open-label study will assess efficacy of weekly doses of Marqibo plus pulse dexamethasone as measured by complete response rate. Secondary objectives are evaluation of safety and disease-free survival. This study is the Phase II portion of an ongoing Phase I/II trial. Hana expects to enroll as many as 44 patients in the Phase II Simon’s two-stage designed trial. Previously treated, relapsed or refractory ALL (including lymphoblastic lymphoma and Burkitt’s subtypes) patients are eligible to enroll in the study.

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