Lymphoma, Follicular Clinical Trial
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
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.
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.
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