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COMPLETED 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

NCT02809053 · View on ClinicalTrials.gov ↗

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

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

1 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 315 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Archigen Biotech Limited, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02809053 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Australian Capital Territory. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02809053?

The interventions under investigation include: SAIT101 (BIOLOGICAL), MabThera® (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02809053?

This trial is sponsored by Archigen Biotech Limited, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial