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NCT05171647 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
A Phase 3 study of Non-Hodgkin Lymphoma, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 208
- Enrollment target
- 20
- Study locations
NCT05171647: Active Phase 3 study of Non-Hodgkin Lymphoma, sponsored by Hoffmann-La Roche.
NCT05171647 is a Phase 3 study of Non-Hodgkin Lymphoma that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 208 participants, above the 166-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05171647, a Phase 3 study of Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 208 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).
Primary Outcome
ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off.
Conditions Studied
Interventions
- DRUG Mosunetuzumab
- DRUG Rituximab
- DRUG Gemcitabine
- DRUG Polatuzumab vedotin
- DRUG Tocilizumab
Study Locations (20)
Other
- Hospital Aleman - Buenos Aires
- Instituto Alexander Fleming - Buenos Aires
- FUNDALEU - Buenos Aires
- Hospital Italiano de Buenos Aires - Ciudad Autonoma Buenos Aires
- D'or Instituto de Pesquisa e Educação - São Paulo
- Sichuan Cancer Hospital - Chengdu
- Fujian Medical University Union Hospital - Fuzhou
- Cancer Center, Sun Yat-sen University of Medical Sciences - Guangzhou
- Tianjin Cancer Hospital - Tianjin
Texas
- Ascension Seton Infusion Center - Austin
- MD Anderson Cancer Center - Houston
São Paulo
- Hospital das Clínicas FMRP-USP - Ribeirão Preto
- Hospital Sao Jose - São Paulo
Ontario
- Hamilton Health Sciences - Juravinski Cancer Centre - Hamilton
- Princess Margaret Hospital - Toronto
California
- City of Hope Cancer Center - Duarte
Missouri
- St. Luke's Hospital - Chesterfield
Paraná
- Hospital Erasto Gaertner - Curitiba
Rio Grande do Sul
- Hospital das Clinicas - UFRGS - Porto Alegre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2022-04-25 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 3 |
What the registry record for NCT05171647 still lists
NCT05171647 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 166-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (25% higher).
The record links to 1 condition, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Mosunetuzumab is the first listed.
NCT05171647 names 20 study sites across 9 states, led by Other, Texas, São Paulo.
Frequently Asked Questions
What is clinical trial NCT05171647 about?
NCT05171647 is a clinical study titled "A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma". This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparis...
What is the current status of trial NCT05171647?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2022-04-25. Estimated completion is 2027-02-28.
What conditions does trial NCT05171647 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT05171647?
The interventions under investigation include: Mosunetuzumab (DRUG), Rituximab (DRUG), Gemcitabine (DRUG), Polatuzumab vedotin (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT05171647?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05171647 being conducted?
This trial has 20 study locations across California, Missouri, Texas, Paraná, Rio Grande do Sul. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05171647's enrollment target sits among peer trials
208 21st of 106 higher than 86 of 106 other Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin Lymphoma 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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