Last updated on March 2019

A Randomized Double-blind Multi-center Multi-national Trial to Evaluate the Efficacy Safety and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma


Brief description of study

This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma.

Detailed Study Description

This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma. Patients will be randomized in a 1:1 ratio to receive study drug once a week for 4 weeks, and will then be followed up for up to 52 weeks after the first dose. Randomization will be stratified by inclusion in the PK/PD sub-population and Follicular lymphoma international prognostic index 2 (FLIPI-2) score.

Visits are scheduled at Weeks 1, 2, 3, and 4 (study drug infusion visits), and then at Weeks 5, 12, 20, 28, 36, and 52 (i.e., End of Study [EOS]). Efficacy response assessments will be performed at Weeks 12 and 28, while safety assessments will continue until EOS.

The primary objectives is To compare the efficacy of SAIT101 with rituximab licensed in the European Union (hereafter designated MabThera, brand name in EU) when administered as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTBFL) and the secondary objectives isTo evaluate SAIT101 versus MabThera with respect to safety and tolerability, immunogenicity and Pharmacokinetics (PK)/Pharmacodynamics (PD) in a sub-population of patients.

Clinical Study Identifier: NCT02809053

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Whittier, CA United States

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Canberra, Australia

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Temuco, Chile

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Hradec Kralove, Czechia

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Praha, Czechia

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Praha, Czechia

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Libourne Cedex, France

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Poitiers, France

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Hamburg, Germany

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Budapest, Hungary

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San Giovanni Rotondo, Italy

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Terni, Italy

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Busan, Korea, Republic of

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Seoul, Korea, Republic of

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Mexico City, Mexico

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Pretoria, South Africa

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L'Hospitalet de Llobregat, Spain

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Madrid, Spain

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Ankara, Turkey

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Istanbul, Turkey

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Mersin, Turkey

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Samsun, Turkey

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Norwich, United Kingdom

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Cádiz, Spain

Recruitment Status: Closed


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