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NCT03907488 · ClinicalTrials.gov registry record · Phase 3
Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
A Phase 3 study of Classic Hodgkin Lymphoma and Lymphocyte-Rich Classic Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 994
- Enrollment target
- 20
- Study locations
NCT03907488: Active Phase 3 study of Classic Hodgkin Lymphoma and Lymphocyte-Rich Classic Hodgkin Lymphoma, sponsored by National Cancer Institute (NCI).
NCT03907488 is a Phase 3 study of Classic Hodgkin Lymphoma and Lymphocyte-Rich Classic Hodgkin Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 994 participants, above the 142-participant average among 9 other Classic Hodgkin Lymphoma trials with a reported enrollment target (600% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03907488, a Phase 3 study of Classic Hodgkin Lymphoma and Lymphocyte-Rich Classic Hodgkin Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 994 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, 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. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.
Primary Outcome
Will be reported as the number of participants who have experienced death or progression, measured at two years. Progression will be measured according to the 2014 Lugano classification. Will test the null hypothesis (HR=1) for PFS using stratified log-rank test with a one-sided alpha of 0.021. The analysis will be based on modified intent-to-treat and will include all eligible patients as randomized regardless of treatment received. The one-sided alpha of .021 will control of the overall type-o
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Doxorubicin Hydrochloride
- DRUG Brentuximab Vedotin
- DRUG Dacarbazine
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Cancer Center at Saint Joseph's - Phoenix
- Phoenix Childrens Hospital - Phoenix
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
- USA Health Strada Patient Care Center - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 994 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2026-03-28 |
| Phase | Phase 3 |
What the registry record for NCT03907488 still lists
NCT03907488 is an interventional study that assigns participants to a tested intervention. The registered 994 participants enrollment target is mid-sized for trials with a published cap, above the 142-participant average among 9 other Classic Hodgkin Lymphoma trials with a reported enrollment target (600% higher).
The record links to 10 conditions, with Classic Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03907488 names 20 study sites across 4 states, led by Alaska, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03907488 about?
NCT03907488 is a clinical study titled "Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma". This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune sy...
What is the current status of trial NCT03907488?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 994 participants. The study started on 2019-08-29. Estimated completion is 2026-03-28.
What conditions does trial NCT03907488 study?
This clinical trial studies the following conditions: Classic Hodgkin Lymphoma, Lymphocyte-Rich Classic Hodgkin Lymphoma, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma.
What interventions are being tested in trial NCT03907488?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Doxorubicin Hydrochloride (DRUG), Brentuximab Vedotin (DRUG), Dacarbazine (DRUG).
Who is sponsoring clinical trial NCT03907488?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03907488 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas. 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 NCT03907488's enrollment target sits among peer trials
994 1st of 9 higher than 9 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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