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• W2280147653 abstract "6507 Background: Management of adult ALL patients who relapse is challenging due to highly drug resistant disease and frequent residual therapy-induced toxicity. The increasing success of Salvage 1 therapy and near universal risk of subsequent relapse has created a need for potent Salvage 2 therapy. Vincristine sulfate liposomes injection (VSLI, Marqibo) is a nanoparticle formulation of vincristine (VCR) that facilitates dose-intensive treatment and shows promising anticancer activity in ALL and lymphoma patients. Methods: In a phase II, open-label, multicenter study, 65 adult patients with Ph- ALL in second relapse or who progressed after two prior lines of treatment received VSLI 2.25 mg/m2 with no dose cap IV weekly over 1 hr. PK profiles were investigated in 13-patients. In 56 patients with available data, median age was 32 yrs (19-83), 24 (43%) had received a prior stem cell transplant (SCT), 11 (20%) had extramedullary disease, 56 (100%) had prior VCR exposure, and 19 (34%) had residual neuropathy. Results: Response rate in the 56 patients was 36%, consisting of 12 complete remissions (CR) and CRs without complete neutrophil or platelet recovery (CRi), 2 bone marrow blast responses, and 6 partial remissions. Median CR/CRi duration was 4 months (1-10.5). Median overall survival (OS) was 4.6 months. Median OS in CR/CRi patients was 7.3 months. Seven responders, including 6 CR/CRi patients, received subsequent SCT. The median cumulative VSLI dose (in terms of VCR) was 19.5 mg (3.5-70.1). The most common related adverse events of grade ≥ 3 were neuropathy (20%), febrile neutropenia (5%), constipation (2%), and anorexia (2%). The Cl was 212 mL/hr/m2, the terminal T1/2 was 7.2 hrs and the Vss was 1,850 mL/m2. Conclusions: VSLI is highly active and provides clinical benefit with modest neurotoxicity as a single agent in heavily pre-treated adult patients with multiple relapsed or refractory Ph- ALL. The anti- leukemia activity is attributable to the VSLI formulation that enables delivery of individual and cumulative VCR doses that can not be delivered by standard formulation VCR. PK data support that most VCR remains in the liposome during VSLI vascular compartment circulation. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Hana Biosciences Hana Biosciences" @default.
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• W2280147653 date "2010-05-20" @default.
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• W2280147653 title "Phase II study of marqibo in adult patients with refractory or relapsed philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL)." @default.
• W2280147653 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.6507" @default.
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