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NCT02809053 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Lymphoma, Follicular, sponsored by Archigen Biotech Limited.

Completed
Registry status
Phase 3
Development phase
315
Enrollment target
20
Study locations

NCT02809053 is a Phase 3 study of Lymphoma, Follicular that has completed, run by Archigen Biotech Limited. The registered enrollment target is 315 participants, above the 97-participant average among 9 other Lymphoma, Follicular trials with a reported enrollment target (225% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT02809053, a Phase 3 study of Lymphoma, Follicular, has completed, sponsored by Archigen Biotech Limited.

COMPLETED
Registry status
Phase 3
Development phase
315 participants
Enrollment target
20
Study locations

Study 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 Studied

Lymphoma, Follicular

Interventions

  • BIOLOGICAL SAIT101
  • BIOLOGICAL MabThera®

Study Locations (20)

Other

  • Research site - Hradec Králové
  • Research site - Prague
  • Reasearch site - Prague
  • Research site - Hamburg
  • Research site - Budapest
  • Research site - Terni
  • Research site - Busan
  • Research site - Seoul
  • Research site - Seoul
  • Research site - Cadiz
  • Research site - Madrid

California

  • Research site - Whittier

Australian Capital Territory

  • Research Site - Canberra

Región de la Araucanía

  • Research site - Temuco

Gironde

  • Research site - Libourne

Vienne

  • Research site - Poitiers

Foggia

  • Research site - San Giovanni Rotondo

Mexico City

  • Research site - Mexico City

Trial Details

FieldValue
Enrollment Target 315 participants
Start Date 2017-01-18
Est. Completion 2020-01-10
Phase Phase 3

Sponsor

Archigen Biotech Limited

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02809053

The ClinicalTrials.gov registry entry for NCT02809053 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 315 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 97-participant average among 9 other Lymphoma, Follicular trials with a reported enrollment target (225% higher). The listed sponsor is Archigen Biotech Limited, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lymphoma, Follicular appearing as the primary indexed condition, and to 2 interventions - of which SAIT101 is the first listed.

NCT02809053 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Australian Capital Territory.

Frequently Asked Questions

What is clinical trial NCT02809053 about?

NCT02809053 is a clinical study titled "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.

What is the current status of trial NCT02809053?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2017-01-18. Estimated completion is 2020-01-10.

What conditions does trial NCT02809053 study?

This clinical trial studies the following conditions: Lymphoma, Follicular.

What interventions are being tested in trial NCT02809053?

The interventions under investigation include: SAIT101 (BIOLOGICAL), MabThera® (BIOLOGICAL).

Who is sponsoring clinical trial NCT02809053?

This trial is sponsored by Archigen Biotech Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02809053 being conducted?

This trial has 20 study locations across California, Australian Capital Territory, Región de la Araucanía, Gironde, Vienne. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.