The primary objective of the phase II open-label study is to assess efficacy of weekly doses of Marqibo (vincristine sulfate liposomes injection) 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 clinical trial. Hana expects to enroll up to 44 patients with previously treated, relapsed or refractory acute lymphoblastic leukemia (ALL), including lymphoblastic lymphoma and Burkitt’s subtypes.
Previous positive interim data from a phase I clinical trial evaluating Marqibo in combination with dexamethasone in relapsed or refractory ALL was presented at the American Society of Hematology annual meeting in December 2004. The complete phase I data is expected to be presented in the fourth quarter of 2006.
“Adults with relapsed ALL have very few options for effective therapy. Several trials in lymphoproliferative malignancies including non-Hodgkin’s lymphoma and two phase I trials in ALL have shown promising potential for Marqibo to improve clinical outcomes,” commented Dr Greg Berk, senior vice president and chief medical officer of Hana Biosciences. “This preliminary data supports moving this drug into pivotal trials.”