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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: Completed Phase 3 study of Lymphoma, Follicular, sponsored by Archigen Biotech Limited.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall Response Rate (ORR) (Complete Response \[CR\] + Partial Response \[PR\]) at Week 28, as defined by International Working Group (IWG) criteria 2007. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007. The 95% CI for overall response rate (ORR) was calculated using the Exact method and combined using the Rubin's rule when multiple imputation was applicable.
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
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2017-01-18 |
| Est. Completion | 2020-01-10 |
| Phase | Phase 3 |
What the finished NCT02809053 record still lists
NCT02809053 is an interventional study that assigns participants to a tested intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap, above the 97-participant average among 9 other Lymphoma, Follicular trials with a reported enrollment target (225% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
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Where NCT02809053's enrollment target sits among peer trials
315 1st of 9 higher than 9 of 9 other Lymphoma, Follicular trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma, Follicular trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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