A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

Status: Recruiting
Location: See all (359) locations...
Intervention Type: Drug, Procedure, Other, Biological, Radiation
Study Type: Interventional
Study Phase: Phase 3
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 tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 60
Healthy Volunteers: f
View:

• Patients must be 5 to 60 years of age at the time of enrollment

• Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\]) with stage I or II disease

• Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm)

• Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained

• Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease.

‣ Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality.

• Patients \>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2

• Patients =\< 17 years of age must have a Lansky performance score of \>= 50

• Pediatric patients (age 5-17 years): A serum creatinine based on age/gender as follows (within 28 days prior to enrollment):

‣ 2 to \< 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female)

⁃ \>= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)

⁃ Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility

• For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight

• Total bilirubin =\< 2 x upper limit of normal (ULN) (within 28 days prior to enrollment)

‣ Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome

• Aspartate aminotransferase (AST) =\< 3 x ULN (within 28 days prior to enrollment)

‣ Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome

• Alanine aminotransferase (ALT) =\< 3 x ULN (within 28 days prior to enrollment)

‣ Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome

• Shortening fraction of \>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment)

• Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \> 92% on room air

• Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Locations
United States
Alaska
Providence Alaska Medical Center
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Anchorage
Alabama
Children's Hospital of Alabama
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Birmingham
USA Health Strada Patient Care Center
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Mobile
Arkansas
Arkansas Children's Hospital
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Little Rock
Arizona
CTCA at Western Regional Medical Center
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Goodyear
Phoenix Childrens Hospital
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Phoenix
California
City of Hope Corona
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Corona
Kaiser Permanente Downey Medical Center
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Downey
City of Hope Comprehensive Cancer Center
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Duarte
Kaiser Permanente Dublin
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Dublin
Kaiser Permanente-Fremont
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Fremont
Kaiser Permanente Fresno Orchard Plaza
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Fresno
Kaiser Permanente-Fresno
RECRUITING
Fresno
City of Hope Seacliff
RECRUITING
Huntington Beach
City of Hope at Irvine Lennar
RECRUITING
Irvine
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING
Irvine
City of Hope Antelope Valley
RECRUITING
Lancaster
Loma Linda University Medical Center
RECRUITING
Loma Linda
City of Hope at Long Beach Elm
RECRUITING
Long Beach
Miller Children's and Women's Hospital Long Beach
RECRUITING
Long Beach
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Children's Hospital Los Angeles
RECRUITING
Los Angeles
Kaiser Permanente-Modesto
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Modesto
City of Hope Newport Beach
RECRUITING
Newport Beach
Kaiser Permanente-Oakland
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Oakland
Children's Hospital of Orange County
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Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
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Orange
Kaiser Permanente Downtown Commons
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Sacramento
Kaiser Permanente-South Sacramento
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Sacramento
Naval Medical Center -San Diego
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San Diego
Rady Children's Hospital - San Diego
RECRUITING
San Diego
Kaiser Permanente-San Francisco
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San Francisco
Kaiser Permanente-Santa Teresa-San Jose
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San Jose
Kaiser Permanente San Leandro
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San Leandro
Kaiser San Rafael-Gallinas
RECRUITING
San Rafael
Santa Barbara Cottage Hospital
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Santa Barbara
Kaiser Permanente-Santa Rosa
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Santa Rosa
City of Hope South Pasadena
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South Pasadena
Kaiser Permanente-South San Francisco
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South San Francisco
City of Hope South Bay
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Torrance
City of Hope Upland
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Upland
Kaiser Permanente-Vallejo
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Vallejo
Kaiser Permanente-Walnut Creek
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Walnut Creek
Colorado
Children's Hospital Colorado
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Aurora
Connecticut
Smilow Cancer Hospital-Derby Care Center
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Derby
Smilow Cancer Hospital Care Center-Fairfield
RECRUITING
Fairfield
Smilow Cancer Hospital Care Center at Glastonbury
RECRUITING
Glastonbury
Smilow Cancer Hospital Care Center at Greenwich
RECRUITING
Greenwich
Smilow Cancer Hospital Care Center - Guilford
RECRUITING
Guilford
Connecticut Children's Medical Center
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Hartford
Smilow Cancer Hospital Care Center at Saint Francis
RECRUITING
Hartford
Yale University
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New Haven
Yale-New Haven Hospital North Haven Medical Center
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North Haven
Smilow Cancer Hospital Care Center at Long Ridge
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Stamford
Smilow Cancer Hospital-Torrington Care Center
RECRUITING
Torrington
Smilow Cancer Hospital Care Center-Trumbull
RECRUITING
Trumbull
Smilow Cancer Hospital-Waterbury Care Center
RECRUITING
Waterbury
Smilow Cancer Hospital Care Center - Waterford
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Waterford
Washington, D.c.
Children's National Medical Center
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Washington D.c.
MedStar Georgetown University Hospital
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Washington D.c.
Delaware
Alfred I duPont Hospital for Children
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Wilmington
Florida
Broward Health Medical Center
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Fort Lauderdale
Golisano Children's Hospital of Southwest Florida
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Fort Myers
University of Florida Health Science Center - Gainesville
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Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Hollywood
Nemours Children's Clinic-Jacksonville
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Jacksonville
Nicklaus Children's Hospital
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Miami
AdventHealth Orlando
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Orlando
Arnold Palmer Hospital for Children
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Orlando
Nemours Children's Hospital
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Orlando
Nemours Children's Clinic - Pensacola
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Pensacola
Sacred Heart Hospital
SUSPENDED
Pensacola
Johns Hopkins All Children's Hospital
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St. Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
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Tampa
Tampa General Hospital
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Tampa
Saint Mary's Medical Center
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West Palm Beach
Georgia
Children's Healthcare of Atlanta - Arthur M Blank Hospital
RECRUITING
Atlanta
Emory Proton Therapy Center
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Atlanta
Emory Saint Joseph's Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
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Atlanta
Emory University Hospital/Winship Cancer Institute
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Atlanta
Grady Health System
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Atlanta
Augusta University Medical Center
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Augusta
Atrium Health Navicent
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Macon
Hawaii
Kapiolani Medical Center for Women and Children
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Honolulu
Iowa
UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Ankeny
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Clive
Blank Children's Hospital
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Des Moines
Iowa Methodist Medical Center
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Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des Moines
University of Iowa/Holden Comprehensive Cancer Center
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Iowa City
UI Health Care Mission Cancer and Blood - Waukee Clinic
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Waukee
Idaho
Saint Luke's Cancer Institute - Boise
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Boise
Saint Luke's Cancer Institute - Fruitland
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Fruitland
Saint Luke's Cancer Institute - Meridian
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Meridian
Saint Luke's Cancer Institute - Nampa
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Nampa
Saint Luke's Cancer Institute - Twin Falls
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Twin Falls
Illinois
Rush-Copley Medical Center
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Aurora
Advocate Good Shepherd Hospital
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Barrington
Advocate Illinois Masonic Medical Center
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Chicago
Lurie Children's Hospital-Chicago
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Chicago
Mount Sinai Hospital Medical Center
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Chicago
Northwestern University
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Chicago
University of Chicago Comprehensive Cancer Center
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Chicago
University of Illinois
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Chicago
AMG Crystal Lake - Oncology
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Crystal Lake
Carle at The Riverfront
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Danville
Decatur Memorial Hospital
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Decatur
Northwestern Medicine Cancer Center Kishwaukee
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Dekalb
Advocate Good Samaritan Hospital
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Downers Grove
Carle Physician Group-Effingham
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Effingham
Crossroads Cancer Center
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Effingham
Advocate Sherman Hospital
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Elgin
Elmhurst Memorial Hospital
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Elmhurst
Northwestern Medicine Cancer Center Delnor
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Geneva
Northwestern Medicine Glenview Outpatient Center
ACTIVE_NOT_RECRUITING
Glenview
Northwestern Medicine Grayslake Outpatient Center
ACTIVE_NOT_RECRUITING
Grayslake
Advocate South Suburban Hospital
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Hazel Crest
Northwestern Medicine Lake Forest Hospital
ACTIVE_NOT_RECRUITING
Lake Forest
AMG Libertyville - Oncology
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Libertyville
Condell Memorial Hospital
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Libertyville
Carle Physician Group-Mattoon/Charleston
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Mattoon
Loyola University Medical Center
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Maywood
Edward Hospital/Cancer Center
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Naperville
HSHS Saint Elizabeth's Hospital
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O'fallon
Advocate Children's Hospital-Oak Lawn
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Oak Lawn
Advocate Christ Medical Center
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Oak Lawn
Northwestern Medicine Orland Park
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Orland Park
Advocate Children's Hospital-Park Ridge
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Park Ridge
Advocate Lutheran General Hospital
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Park Ridge
Saint Jude Midwest Affiliate
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Peoria
Edward Hospital/Cancer Center?Plainfield
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Plainfield
UW Health Carbone Cancer Center Rockford
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Rockford
Memorial Hospital East
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Shiloh
Southern Illinois University School of Medicine
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Springfield
Carle Cancer Center
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Urbana
Northwestern Medicine Cancer Center Warrenville
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Warrenville
Rush-Copley Healthcare Center
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Yorkville
Indiana
Ascension Saint Vincent Indianapolis Hospital
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Indianapolis
Riley Hospital for Children
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Indianapolis
Kansas
Wesley Medical Center
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Wichita
Kentucky
University of Kentucky/Markey Cancer Center
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Lexington
Norton Children's Hospital
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Louisville
The James Graham Brown Cancer Center at University of Louisville
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Louisville
UofL Health Medical Center Northeast
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Louisville
Louisiana
Children's Hospital New Orleans
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New Orleans
Ochsner Medical Center Jefferson
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New Orleans
Massachusetts
Dana-Farber Cancer Institute
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Boston
UMass Memorial Medical Center - University Campus
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Worcester
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore
Sinai Hospital of Baltimore
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Baltimore
University of Maryland/Greenebaum Cancer Center
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Baltimore
Walter Reed National Military Medical Center
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Bethesda
Maine
Eastern Maine Medical Center
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Bangor
Maine Children's Cancer Program
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Scarborough
Michigan
C S Mott Children's Hospital
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Ann Arbor
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Ann Arbor
Bronson Battle Creek
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Battle Creek
Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Chelsea
Henry Ford Macomb Hospital-Clinton Township
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Clinton Township
Corewell Health Dearborn Hospital
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Dearborn
Children's Hospital of Michigan
RECRUITING
Detroit
Henry Ford Hospital
RECRUITING
Detroit
Wayne State University/Karmanos Cancer Institute
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Detroit
Michigan State University
ACTIVE_NOT_RECRUITING
East Lansing
Corewell Health Farmington Hills Hospital
RECRUITING
Farmington Hills
Weisberg Cancer Treatment Center
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Farmington Hills
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITING
Grand Rapids
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grand Rapids
Trinity Health Grand Rapids Hospital
RECRUITING
Grand Rapids
Beacon Kalamazoo Cancer Center
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Kalamazoo
Bronson Methodist Hospital
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Kalamazoo
West Michigan Cancer Center
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Kalamazoo
Trinity Health Saint Mary Mercy Livonia Hospital
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Livonia
Trinity Health Muskegon Hospital
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Muskegon
Cancer and Hematology Centers of Western Michigan - Norton Shores
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Norton Shores
Henry Ford Medical Center-Columbus
RECRUITING
Novi
Corewell Health Reed City Hospital
RECRUITING
Reed City
Corewell Health Children's
RECRUITING
Royal Oak
Corewell Health William Beaumont University Hospital
RECRUITING
Royal Oak
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
RECRUITING
Saint Joseph
Munson Medical Center
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Traverse City
Corewell Health Beaumont Troy Hospital
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Troy
Henry Ford West Bloomfield Hospital
RECRUITING
West Bloomfield
University of Michigan Health - West
RECRUITING
Wyoming
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Mercy Hospital
RECRUITING
Coon Rapids
Fairview Southdale Hospital
RECRUITING
Edina
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis
University of Minnesota/Masonic Cancer Center
RECRUITING
Minneapolis
Mayo Clinic in Rochester
RECRUITING
Rochester
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
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Saint Paul
United Hospital
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Saint Paul
Missouri
Saint Luke's Hospital
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Chesterfield
Siteman Cancer Center at Saint Peters Hospital
RECRUITING
City Of Saint Peters
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
Children's Mercy Hospitals and Clinics
RECRUITING
Kansas City
Cardinal Glennon Children's Medical Center
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St Louis
Mercy Hospital Saint Louis
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St Louis
Siteman Cancer Center at Christian Hospital
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St Louis
Siteman Cancer Center-South County
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St Louis
Washington University School of Medicine
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St Louis
Mississippi
University of Mississippi Medical Center
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Jackson
North Carolina
Mission Hospital
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Asheville
UNC Lineberger Comprehensive Cancer Center
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Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
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Charlotte
Duke University Medical Center
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Durham
East Carolina University
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Greenville
Wake Forest University Health Sciences
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Winston-salem
North Dakota
Sanford Broadway Medical Center
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Fargo
Nebraska
Nebraska Medicine-Bellevue
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Bellevue
Children's Hospital and Medical Center of Omaha
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Omaha
Nebraska Medicine-Village Pointe
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Omaha
University of Nebraska Medical Center
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Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
New Jersey
Cooper Hospital University Medical Center
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Camden
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
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Elizabeth
Hackensack University Medical Center
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Hackensack
Jersey City Medical Center
RECRUITING
Jersey City
Saint Barnabas Medical Center
SUSPENDED
Livingston
Monmouth Medical Center
RECRUITING
Long Branch
Morristown Medical Center
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Morristown
Jersey Shore Medical Center
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Neptune City
Rutgers Cancer Institute of New Jersey
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New Brunswick
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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New Brunswick
Saint Peter's University Hospital
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New Brunswick
Newark Beth Israel Medical Center
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Newark
Saint Joseph's Regional Medical Center
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Paterson
Community Medical Center
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Toms River
New Mexico
Presbyterian Hospital
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Albuquerque
University of New Mexico Cancer Center
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Albuquerque
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
RECRUITING
Las Vegas
Renown Regional Medical Center
RECRUITING
Reno
New York
Albany Medical Center
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Albany
Roswell Park Cancer Institute
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Buffalo
Hematology Oncology Associates of CNY at Camillus
RECRUITING
Camillus
Hematology Oncology Associates of Central New York-East Syracuse
RECRUITING
East Syracuse
Glens Falls Hospital
RECRUITING
Glens Falls
NYU Langone Hospital - Long Island
RECRUITING
Mineola
The Steven and Alexandra Cohen Children's Medical Center of New York
RECRUITING
New Hyde Park
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
RECRUITING
New York
NYP/Weill Cornell Medical Center
RECRUITING
New York
University of Rochester
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Rochester
Stony Brook University Medical Center
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Stony Brook
State University of New York Upstate Medical University
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Syracuse
Montefiore Medical Center - Moses Campus
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The Bronx
Wilmot Cancer Institute at Webster
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Webster
Ohio
Children's Hospital Medical Center of Akron
RECRUITING
Akron
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Cleveland Clinic Foundation
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Cleveland
Rainbow Babies and Childrens Hospital
RECRUITING
Cleveland
Nationwide Children's Hospital
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Columbus
Dayton Children's Hospital
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Dayton
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
RECRUITING
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Providence Willamette Falls Medical Center
RECRUITING
Oregon City
Legacy Emanuel Children's Hospital
RECRUITING
Portland
Oregon Health and Science University
RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
RECRUITING
Allentown
Geisinger Medical Center
RECRUITING
Danville
Penn State Children's Hospital
RECRUITING
Hershey
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Saint Christopher's Hospital for Children
RECRUITING
Philadelphia
Children's Hospital of Pittsburgh of UPMC
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Smilow Cancer Hospital Care Center - Westerly
RECRUITING
Westerly
South Carolina
Prisma Health Cancer Institute - Spartanburg
RECRUITING
Boiling Springs
Medical University of South Carolina
RECRUITING
Charleston
Prisma Health Richland Hospital
RECRUITING
Columbia
BI-LO Charities Children's Cancer Center
RECRUITING
Greenville
Prisma Health Cancer Institute - Eastside
RECRUITING
Greenville
Saint Francis Cancer Center
RECRUITING
Greenville
Saint Francis Hospital
RECRUITING
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
T C Thompson Children's Hospital
SUSPENDED
Chattanooga
East Tennessee Childrens Hospital
RECRUITING
Knoxville
The Children's Hospital at TriStar Centennial
RECRUITING
Nashville
Vanderbilt University/Ingram Cancer Center
RECRUITING
Nashville
Texas
Dell Children's Medical Center of Central Texas
RECRUITING
Austin
Driscoll Children's Hospital
RECRUITING
Corpus Christi
Medical City Dallas Hospital
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
El Paso Children's Hospital
RECRUITING
El Paso
Cook Children's Medical Center
RECRUITING
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING
Houston
M D Anderson Cancer Center
RECRUITING
Houston
Covenant Children's Hospital
RECRUITING
Lubbock
UMC Cancer Center / UMC Health System
RECRUITING
Lubbock
Children's Hospital of San Antonio
RECRUITING
San Antonio
Methodist Children's Hospital of South Texas
RECRUITING
San Antonio
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Scott and White Memorial Hospital
RECRUITING
Temple
Utah
Huntsman Cancer Institute/University of Utah
RECRUITING
Salt Lake City
Primary Children's Hospital
RECRUITING
Salt Lake City
Virginia
University of Virginia Cancer Center
RECRUITING
Charlottesville
Inova Fairfax Hospital
RECRUITING
Falls Church
Children's Hospital of The King's Daughters
RECRUITING
Norfolk
Naval Medical Center - Portsmouth
RECRUITING
Portsmouth
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Carilion Children's
RECRUITING
Roanoke
Vermont
University of Vermont and State Agricultural College
RECRUITING
Burlington
Washington
Valley Medical Center
RECRUITING
Renton
Seattle Children's Hospital
RECRUITING
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
RECRUITING
Spokane
Mary Bridge Children's Hospital and Health Center
RECRUITING
Tacoma
Wisconsin
Aurora Cancer Care-Southern Lakes VLCC
RECRUITING
Burlington
Aurora Saint Luke's South Shore
RECRUITING
Cudahy
Aurora Health Care Germantown Health Center
RECRUITING
Germantown
Aurora Cancer Care-Grafton
RECRUITING
Grafton
Aurora BayCare Medical Center
RECRUITING
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING
Green Bay
Aurora Cancer Care-Kenosha South
RECRUITING
Kenosha
Gundersen Lutheran Medical Center
RECRUITING
La Crosse
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
RECRUITING
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING
Madison
Aurora Bay Area Medical Group-Marinette
RECRUITING
Marinette
Marshfield Medical Center-Marshfield
SUSPENDED
Marshfield
Aurora Cancer Care-Milwaukee
RECRUITING
Milwaukee
Aurora Saint Luke's Medical Center
RECRUITING
Milwaukee
Aurora Sinai Medical Center
RECRUITING
Milwaukee
Children's Hospital of Wisconsin
RECRUITING
Milwaukee
ProHealth D N Greenwald Center
RECRUITING
Mukwonago
ProHealth Oconomowoc Memorial Hospital
RECRUITING
Oconomowoc
Vince Lombardi Cancer Clinic - Oshkosh
RECRUITING
Oshkosh
Aurora Cancer Care-Racine
RECRUITING
Racine
Saint Vincent Hospital Cancer Center at Sheboygan
RECRUITING
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
RECRUITING
Sheboygan
Saint Vincent Hospital Cancer Center at Sturgeon Bay
RECRUITING
Sturgeon Bay
Aurora Medical Center in Summit
RECRUITING
Summit
Vince Lombardi Cancer Clinic-Two Rivers
RECRUITING
Two Rivers
UW Cancer Center at ProHealth Care
RECRUITING
Waukesha
Aurora Cancer Care-Milwaukee West
RECRUITING
Wauwatosa
Aurora West Allis Medical Center
RECRUITING
West Allis
West Virginia
West Virginia University Charleston Division
RECRUITING
Charleston
Edwards Comprehensive Cancer Center
RECRUITING
Huntington
Other Locations
Canada
Alberta Children's Hospital
SUSPENDED
Calgary
University of Alberta Hospital
RECRUITING
Edmonton
IWK Health Centre
RECRUITING
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
SUSPENDED
Hamilton
Children's Hospital
SUSPENDED
London
Centre Hospitalier Universitaire Sainte-Justine
RECRUITING
Montreal
The Montreal Children's Hospital of the MUHC
RECRUITING
Montreal
Children's Hospital of Eastern Ontario
SUSPENDED
Ottawa
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
RECRUITING
Québec
Jim Pattison Children's Hospital
RECRUITING
Saskatoon
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
RECRUITING
Sherbrooke
Hospital for Sick Children
SUSPENDED
Toronto
CancerCare Manitoba
RECRUITING
Winnipeg
Puerto Rico
University Pediatric Hospital
RECRUITING
San Juan
Time Frame
Start Date: 2023-05-11
Estimated Completion Date: 2031-04-28
Participants
Target number of participants: 1875
Treatments
Active_comparator: Arm A (ABVD)
Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive ABVD IV for an additional 2 cycles on study. Each cycle lasts 28 days and ABVD is administered on days 1 and 15 of each cycle in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Experimental: Arm B (ABVD, brentuximab vedotin, nivolumab)
Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes once during each treatment cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Experimental: Arm C (ABVD, eBEACOPP or eBPDac, ISRT)
See Detailed Description.
Experimental: Arm D (ABVD, brentuximab vedotin, nivolumab, ISRT)
Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive brentuximab vedotin IV and nivolumab IV as in arm B followed by ISRT. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Experimental: Arm E (ABVD, AVD)
Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive AVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, vinblastine IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Experimental: Arm F (ABVD, brentuximab vedotin, nivolumab)
Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive treatment as in arm B. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.
Experimental: Arm G (ABVD, eBEACOPP or eBPDac, ISRT)
Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive treatment and imaging, and may undergo blood sample collection as in arm C.
Experimental: Arm H (ABVD, brentuximab vedotin, nivolumab, ISRT)
Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive treatment and imaging, and may undergo blood sample collection as in arm B.
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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