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NCT03038672 · ClinicalTrials.gov registry record · Phase 2
Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas
A Phase 2 study of Diffuse Large B-Cell Lymphoma, Not Otherwise Specified and High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 20
- Study locations
NCT03038672: Active Phase 2 study of Diffuse Large B-Cell Lymphoma, Not Otherwise Specified and High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, sponsored by National Cancer Institute (NCI).
NCT03038672 is a Phase 2 study of Diffuse Large B-Cell Lymphoma, Not Otherwise Specified and High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 54 participants, below the 92-participant average among 9 other Diffuse Large B-Cell Lymphoma, Not Otherwise Specified trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03038672, a Phase 2 study of Diffuse Large B-Cell Lymphoma, Not Otherwise Specified and High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as varlilumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
Will be assessed by computed tomography (CT)-based criteria or positron emission tomography (PET)-CT based criteria. A response will be defined as an objective status of partial remission (PR) or complete remission (CR) for patients evaluated by CT-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) for patients evaluated by PET-CT based criteria. Exact binomial ninety-five percent confidence intervals for the true success proportion will be calculated in eac
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- DRUG Varlilumab
Study Locations (20)
Kansas
- University of Kansas Clinical Research Center - Fairway
- HaysMed - Hays
- University of Kansas Cancer Center - Kansas City
- Lawrence Memorial Hospital - Lawrence
- The University of Kansas Cancer Center - Olathe - Olathe
- University of Kansas Cancer Center-Overland Park - Overland Park
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- Mercy Hospital Pittsburg - Pittsburg
- Salina Regional Health Center - Salina
- University of Kansas Health System Saint Francis Campus - Topeka
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Florida
- Mayo Clinic in Florida - Jacksonville
- Moffitt Cancer Center-International Plaza - Tampa
- Moffitt Cancer Center - McKinley Campus - Tampa
- Moffitt Cancer Center - Tampa
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Illinois
- Northwestern University - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
Georgia
- Northside Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2026-10-24 |
| Phase | Phase 2 |
What the registry record for NCT03038672 still lists
NCT03038672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 92-participant average among 9 other Diffuse Large B-Cell Lymphoma, Not Otherwise Specified trials with a reported enrollment target (41% lower).
The record links to 10 conditions, with Diffuse Large B-Cell Lymphoma, Not Otherwise Specified appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT03038672 names 20 study sites across 5 states, led by Kansas, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03038672 about?
NCT03038672 is a clinical study titled "Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas". This phase II trial studies how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as varlilumab and nivolumab, may help the ...
What is the current status of trial NCT03038672?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2018-12-21. Estimated completion is 2026-10-24.
What conditions does trial NCT03038672 study?
This clinical trial studies the following conditions: Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements, High Grade B-Cell Lymphoma, Not Otherwise Specified, EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type.
What interventions are being tested in trial NCT03038672?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Varlilumab (DRUG).
Who is sponsoring clinical trial NCT03038672?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03038672 being conducted?
This trial has 20 study locations across Arizona, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
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 NCT03038672's enrollment target sits among peer trials
54 6th of 9 higher than 4 of 9 other Diffuse Large B-Cell Lymphoma, Not Otherwise Specified trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B-Cell Lymphoma, Not Otherwise Specified 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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