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NCT02166463 · ClinicalTrials.gov registry record · Phase 3
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
A Phase 3 study of Classic Hodgkin Lymphoma and Ann Arbor Stage IIB Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT02166463: Active Phase 3 study of Classic Hodgkin Lymphoma and Ann Arbor Stage IIB Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
NCT02166463 is a Phase 3 study of Classic Hodgkin Lymphoma and Ann Arbor Stage IIB Hodgkin Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 600 participants, above the 186-participant average among 9 other Classic Hodgkin Lymphoma trials with a reported enrollment target (223% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02166463, a Phase 3 study of Classic Hodgkin Lymphoma and Ann Arbor Stage IIB Hodgkin Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB with bulk, stage IIIB, IVA, or IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Chemotherapy drugs, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, 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. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating children with high-risk Hodgkin lymphoma.
Primary Outcome
Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development o
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- DRUG Etoposide
- BIOLOGICAL Bleomycin Sulfate
- DRUG Brentuximab Vedotin
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- 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
- Valley Children's Hospital - Madera
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- Naval Medical Center -San Diego - San Diego
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2015-03-19 |
| Est. Completion | 2026-10-03 |
| Phase | Phase 3 |
What the registry record for NCT02166463 still lists
NCT02166463 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 186-participant average among 9 other Classic Hodgkin Lymphoma trials with a reported enrollment target (223% higher).
The record links to 6 conditions, with Classic Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02166463 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT02166463 about?
NCT02166463 is a clinical study titled "Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma". This phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB with bulk, stage IIIB, IVA, or IVB Hodgkin lymphoma. Combinations of biological substances in brentu...
What is the current status of trial NCT02166463?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2015-03-19. Estimated completion is 2026-10-03.
What conditions does trial NCT02166463 study?
This clinical trial studies the following conditions: Classic Hodgkin Lymphoma, Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma, Ann Arbor Stage IVA Hodgkin Lymphoma, Ann Arbor Stage IVB Hodgkin Lymphoma.
What interventions are being tested in trial NCT02166463?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Bleomycin Sulfate (BIOLOGICAL), Brentuximab Vedotin (DRUG).
Who is sponsoring clinical trial NCT02166463?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02166463 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 Classic Hodgkin 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 NCT02166463's enrollment target sits among peer trials
600 2nd of 9 the highest of 9 other Classic Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Classic 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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