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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

NCT02809053 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2020-10-08

Study results available
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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.

Conditions

  • Lymphoma, Follicular

Interventions

BIOLOGICAL

SAIT101

Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22

BIOLOGICAL

MabThera®

Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22

Sponsors & Collaborators

  • Archigen Biotech Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-18
Primary Completion
2019-07-17
Completion
2020-01-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Chile
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • South Africa
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02809053 on ClinicalTrials.gov