Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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
Study ID: NCT02809053
Conditions
Study Description
Brief Summary: 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 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 end of Study (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 is to evaluate SAIT101 versus MabThera® with respect to safety and tolerability, immunogenicity and Pharmacokinetics (PK)/Pharmacodynamics (PD) in a sub-population of patients.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research site, Whittier, California, United States
Research Site, Canberra, Australian Capital Territory, Australia
Research site, Temuco, Araucania, Chile
Research site, Hradec Kralove, , Czechia
Research site, Praha, , Czechia
Reasearch site, Praha, , Czechia
Research site, Libourne Cedex, Gironde, France
Research site, Poitiers, Vienne, France
Research site, Hamburg, , Germany
Research site, Budapest, , Hungary
Research site, San Giovanni Rotondo, Foggia, Italy
Research site, Terni, , Italy
Research site, Busan, , Korea, Republic of
Research site, Seoul, , Korea, Republic of
Research site, Seoul, , Korea, Republic of
Research site, Mexico City, Distrito Federal, Mexico
Research site, Pretoria, Gauteng, South Africa
Research site, L'Hospitalet de Llobregat, Barcelona, Spain
Research site, Cádiz, , Spain
Research site, Madrid, , Spain
Research site, Ankara, , Turkey
Research site, Istanbul, , Turkey
Research site, Mersin, , Turkey
Research site, Samsun, , Turkey
Research site, Norwich, Norfolk, United Kingdom
Contact Details
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