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NCT03057795 · ClinicalTrials.gov registry record · Phase 2
Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma
A Phase 2 study of Refractory Hodgkin Lymphoma and Classic Hodgkin Lymphoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 6
- Study locations
NCT03057795: Active Phase 2 study of Refractory Hodgkin Lymphoma and Classic Hodgkin Lymphoma, sponsored by City of Hope Medical Center.
NCT03057795 is a Phase 2 study of Refractory Hodgkin Lymphoma and Classic Hodgkin Lymphoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 62 participants, above the 37-participant average among 11 other Refractory Hodgkin Lymphoma trials with a reported enrollment target (68% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03057795, a Phase 2 study of Refractory Hodgkin Lymphoma and Classic Hodgkin Lymphoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase II trial studies how well nivolumab and brentuximab vedotin work after stem cell transplant in treating patients with high-risk classical Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab and brentuximab, 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
Progression-free survival will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. When there is no censoring in progression-free survival prior to 18 months after the first dose of study treatment, the observed 18-month progression-free survival will be compared to the baseline of 65% by one-sided exact test of binomial proportion. In case of censoring in progression-free survival prior to 18 months after the first dose of study
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- DRUG Brentuximab Vedotin
Study Locations (6)
California
- City of Hope Medical Center - Duarte
Minnesota
- Mayo Clinic in Rochester - Rochester
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Memorial Sloan Kettering Cancer Center - New York
Texas
- M D Anderson Cancer Center - Houston
Washington
- Fred Hutchinson Cancer Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2017-04-03 |
| Est. Completion | 2026-03-25 |
| Phase | Phase 2 |
What the registry record for NCT03057795 still lists
NCT03057795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, above the 37-participant average among 11 other Refractory Hodgkin Lymphoma trials with a reported enrollment target (68% higher).
The record links to 3 conditions, with Refractory Hodgkin Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03057795 lists 6 locations in 6 states (California, Minnesota, New Jersey).
Frequently Asked Questions
What is clinical trial NCT03057795 about?
NCT03057795 is a clinical study titled "Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma". This phase II trial studies how well nivolumab and brentuximab vedotin work after stem cell transplant in treating patients with high-risk classical Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolu...
What is the current status of trial NCT03057795?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2017-04-03. Estimated completion is 2026-03-25.
What conditions does trial NCT03057795 study?
This clinical trial studies the following conditions: Refractory Hodgkin Lymphoma, Classic Hodgkin Lymphoma, Recurrent Hodgkin Lymphoma.
What interventions are being tested in trial NCT03057795?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Brentuximab Vedotin (DRUG).
Who is sponsoring clinical trial NCT03057795?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03057795 being conducted?
This trial has 6 study locations across California, Minnesota, New Jersey, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03057795's enrollment target sits among peer trials
62 3rd of 11 higher than 9 of 11 other Refractory Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory 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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