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NCT04759586 · ClinicalTrials.gov registry record · Phase 3
Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
A Phase 3 study of Primary Mediastinal Large B Cell Lymphoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 244
- Enrollment target
- 20
- Study locations
NCT04759586: Active Phase 3 study of Primary Mediastinal Large B Cell Lymphoma, sponsored by National Cancer Institute (NCI).
NCT04759586 is a Phase 3 study of Primary Mediastinal Large B Cell Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 244 participants, above the 39-participant average among 11 other Primary Mediastinal Large B Cell Lymphoma trials with a reported enrollment target (526% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04759586, a Phase 3 study of Primary Mediastinal Large B Cell Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 244 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
Primary Outcome
The primary analysis will be a one-sided Log-rank test stratified by choice of backbone and radiation therapy and whether the patient had a cycle of therapy prior to enrolling.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
Study Locations (20)
California
- UC Irvine Health Cancer Center-Newport - Costa Mesa
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- City of Hope at Irvine Lennar - Irvine
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arizona
- Banner Children's at Desert - Mesa
- Banner University Medical Center - Tucson - Tucson
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT04759586 still lists
NCT04759586 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, above the 39-participant average among 11 other Primary Mediastinal Large B Cell Lymphoma trials with a reported enrollment target (526% higher).
The record links to 1 condition, with Primary Mediastinal Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04759586 names 20 study sites across 5 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT04759586 about?
NCT04759586 is a clinical study titled "Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma". This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attac...
What is the current status of trial NCT04759586?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 244 participants. The study started on 2021-10-05. Estimated completion is 2026-12-31.
What conditions does trial NCT04759586 study?
This clinical trial studies the following conditions: Primary Mediastinal Large B Cell Lymphoma.
What interventions are being tested in trial NCT04759586?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE).
Who is sponsoring clinical trial NCT04759586?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04759586 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Mediastinal Large B Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04759586's enrollment target sits among peer trials
244 1st of 11 higher than 11 of 11 other Primary Mediastinal Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Mediastinal 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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