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NCT04182204 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
A Phase 3 study of Diffuse Large B Cell Lymphoma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
- 20
- Study locations
NCT04182204: Completed Phase 3 study of Diffuse Large B Cell Lymphoma, sponsored by Hoffmann-La Roche.
NCT04182204 is a Phase 3 study of Diffuse Large B Cell Lymphoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 270 participants, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04182204, a Phase 3 study of Diffuse Large B Cell Lymphoma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT).
Primary Outcome
An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Conditions Studied
Interventions
- DRUG Oxaliplatin
- DRUG Rituximab
- DRUG Gemcitabine
- DRUG Polatuzumab Vedotin
Study Locations (20)
Other
- Hu Nan Provincial Cancer Hospital - Changsha
- West China Hospital - Sichuan University - Chengdu
- Cancer Center, Sun Yat-sen University of Medical Sciences - Guangzhou
- The 1st Affiliated Hospital of Nanchang Unversity - Nanchang
- Guangxi Cancer Hospital of Guangxi Medical University - Nanning
- Institute of Hematology and Hospital of Blood Disease - Tianjin
Florida
- Cancer Specialists - Jacksonville
- Memorial Cancer Institute at Memorial West - Pembroke Pines
New Jersey
- MSKCC at Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Cancer Center at Bergen - Montvale
New York
- Memorial Sloan-Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
Ontario
- London Health Sciences Centre - London
- Niagara Health Systems - St. Catherines General Site - St. Catharines
Michigan
- IHA Hematology Oncology Consultants - Ann Arbor - Ann Arbor
Estado de Bahia
- Hospital Sao Rafael - HSR - Salvador
Rio Grande do Norte
- Liga Norte Riograndense Contra O Câncer - Natal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2020-02-07 |
| Est. Completion | 2024-11-29 |
| Phase | Phase 3 |
What the finished NCT04182204 record still lists
NCT04182204 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, above the 216-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (25% higher).
The record links to 1 condition, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Oxaliplatin is the first listed.
NCT04182204 names 20 study sites across 11 states, led by Other, Florida, New Jersey.
Frequently Asked Questions
What is clinical trial NCT04182204 about?
NCT04182204 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma". This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a ...
What is the current status of trial NCT04182204?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2020-02-07. Estimated completion is 2024-11-29.
What conditions does trial NCT04182204 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma.
What interventions are being tested in trial NCT04182204?
The interventions under investigation include: Oxaliplatin (DRUG), Rituximab (DRUG), Gemcitabine (DRUG), Polatuzumab Vedotin (DRUG).
Who is sponsoring clinical trial NCT04182204?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04182204 being conducted?
This trial has 20 study locations across Florida, Michigan, New Jersey, New York, Estado de Bahia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04182204's enrollment target sits among peer trials
270 22nd of 114 higher than 92 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell 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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