At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 315 enrolled
Drug / intervention
SAIT101 +1 morebiological
Likely dose
SAIT101 375mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SAIT101 and MabThera® for Lymphoma, Follicular. Completed, enrolled 315 participants across 25 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Follicular
CountriesAustralia, Chile, Czechia, France, Germany, Hungary, Italy, Mexico, South Africa, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJan 2017
Primary CompletionJul 2019
Study CompletionJan 2020
TodayJul 2026
First PostedJun 22, 2016
Enrollment StartJan 18, 2017
Primary CompletionJul 17, 2019
Study CompletionJan 10, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.0 years ago
Interventions
SAIT101biological
Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22
MabThera®biological
Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22