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- W2591346477 abstract "6637 Background: Sphingosomal vincristine (SV), a novel formulation of vincristine encapsulated in sphingomyelin/cholesterol liposomes or ‘sphingosomes’ was evaluated for the treatment of multiply relapsed aggressive NHL patients in two studies. While combination chemotherapy is the standard front-line treatment, there remains a substantial need for new effective treatments for multiply relapsed patients. Methods: The Phase IIa and IIb trials were single-arm, open-label studies that evaluated the efficacy and safety of single-agent SV administered at 2.0 mg/m2 every 2 weeks. Primary efficacy endpoint in both studies was the ORR, with time-to-event variables evaluated as secondary endpoints. The Phase IIb study was a multicenter international trial while the Phase IIa was a single-center study. Results: In total 211 patients with aggressive NHL were treated in the Phase IIa (92 pts) and Phase IIb (119 pts) studies. Demographic and baseline characteristics were comparable providing evidence in support of efficacy data pooling. Median age was 62 years and median prior treatments was 3. Two-thirds of patients had disease resistant to their last therapy. The ORR was 28% (7% CR/CRu, 21% PR) with a 95% CI of [22%, 35%]. Estimated median TTP was approximately 4 months and overall median survival was estimated at ∼8.5 months. ORR of 48% and estimated median survival of 27 months was reported in patients with sensitive disease compared to 18% and 6 months for patients with resistant disease. Conclusions: New therapies are needed for patients with multiply relapsed aggressive NHL. Single-agent therapy with SV resulted in clinically meaningful rate of response in this heavily pre-treated population. Patients with sensitive disease had a higher response rate and longer estimated median survival than patients with resistant disease. No significant financial relationships to disclose." @default.
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- W2591346477 date "2005-06-01" @default.
- W2591346477 modified "2023-09-27" @default.
- W2591346477 title "Integrated efficacy results from two phase II studies utilizing sphingosomal vincristine for the treatment of multiply relapsed or refractory non-Hodgkin’s lymphoma" @default.
- W2591346477 doi "https://doi.org/10.1200/jco.2005.23.16_suppl.6637" @default.
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