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NCT05675410 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
A Phase 3 study of Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,875
- Enrollment target
- 20
- Study locations
NCT05675410 is a Phase 3 study of Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 1,875 participants. The trial reports 20 study locations across 5 states.
The verdict
NCT05675410, a Phase 3 study of Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,875 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). 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. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Bleomycin Sulfate
- DRUG Brentuximab Vedotin
Study Locations (20)
California
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- City of Hope Corona - Corona
- UC Irvine Health Cancer Center-Newport - Costa Mesa
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente Dublin - Dublin
- Mercy Cancer Center - Elk Grove - Elk Grove
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente Fresno Orchard Plaza - Fresno
- Kaiser Permanente-Fresno - Fresno
- City of Hope Seacliff - Huntington Beach
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
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 | 1,875 participants |
| Start Date | 2023-05-11 |
| Est. Completion | 2031-04-28 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05675410
The ClinicalTrials.gov registry entry for NCT05675410 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,875 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05675410 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05675410 about?
NCT05675410 is a clinical study titled "A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab". This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is...
What is the current status of trial NCT05675410?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,875 participants. The study started on 2023-05-11. Estimated completion is 2031-04-28.
What conditions does trial NCT05675410 study?
This clinical trial studies the following conditions: Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8.
What interventions are being tested in trial NCT05675410?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bleomycin Sulfate (BIOLOGICAL), Brentuximab Vedotin (DRUG).
Who is sponsoring clinical trial NCT05675410?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05675410 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.
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