RECRUITING

A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

Conditions

Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-11

Study Completion:2031-04-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05675410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* 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) * 6 to \< 10 years (age): 1 mg/dL (male), 1 mg/dL (female) * 10 to \< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female) * 13 to \< 16 years (age): 1.5 mg/dL (male), 1.4 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	* Patients with nodular lymphocyte predominant Hodgkin lymphoma * Patients with a history of active interstitial pneumonitis or interstitial lung disease * Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients * Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills * Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily predniSONE for patients \>= 18 years or \> 0.5 mg/kg \[up to 10 mg/day\] for patients \< 18 years) or other immunosuppressive medications within 14 days prior to enrollment * Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\< 10 mg daily for patients \>= 18 years or =\< 0.5 mg/kg \[up to 10 mg/day\] predniSONE equivalents) are permitted in the absence of active autoimmune disease * Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1 * Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids. * Patients with peripheral neuropathy \> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL * Prior solid organ transplant * Prior allogeneic stem cell transplantation * Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \[BCG\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment * Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer * Men and women of childbearing potential must continue contraception for a period of 6 months after last dose of brentuximab vedotin * Women of child-bearing potential (WOCBP) must continue contraception for a period of at least 5 months after the last dose of nivolumab * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Inclusion Criteria

Exclusion Criteria

* 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)
* 6 to \< 10 years (age): 1 mg/dL (male), 1 mg/dL (female)
* 10 to \< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female)
* 13 to \< 16 years (age): 1.5 mg/dL (male), 1.4 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

* Patients with nodular lymphocyte predominant Hodgkin lymphoma
* Patients with a history of active interstitial pneumonitis or interstitial lung disease
* Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
* Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills
* Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily predniSONE for patients \>= 18 years or \> 0.5 mg/kg \[up to 10 mg/day\] for patients \< 18 years) or other immunosuppressive medications within 14 days prior to enrollment
* Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\< 10 mg daily for patients \>= 18 years or =\< 0.5 mg/kg \[up to 10 mg/day\] predniSONE equivalents) are permitted in the absence of active autoimmune disease
* Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1
* Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.
* Patients with peripheral neuropathy \> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
* Prior solid organ transplant
* Prior allogeneic stem cell transplantation
* Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \[BCG\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential
* Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment
* Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer
* Men and women of childbearing potential must continue contraception for a period of 6 months after last dose of brentuximab vedotin
* Women of child-bearing potential (WOCBP) must continue contraception for a period of at least 5 months after the last dose of nivolumab
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Contacts and Locations

Principal Investigator

Kara M Kelly

PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Study Locations (Sites)

USA Health Strada Patient Care Center

Mobile, Alabama, 36604

United States

Providence Alaska Medical Center

Anchorage, Alaska, 99508

United States

CTCA at Western Regional Medical Center

Goodyear, Arizona, 85338

United States

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

United States

Kaiser Permanente Downey Medical Center

Downey, California, 90242

United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

Kaiser Permanente Dublin

Dublin, California, 94568

United States

Kaiser Permanente-Fremont

Fremont, California, 94538

United States

Kaiser Permanente-Fresno

Fresno, California, 93720

United States

City of Hope Seacliff

Huntington Beach, California, 92648

United States

City of Hope at Irvine Lennar

Irvine, California, 92618

United States

City of Hope Antelope Valley

Lancaster, California, 93534

United States

Loma Linda University Medical Center

Loma Linda, California, 92354

United States

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806

United States

City of Hope at Long Beach Elm

Long Beach, California, 90813

United States

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Kaiser Permanente-Modesto

Modesto, California, 95356

United States

City of Hope Newport Beach

Newport Beach, California, 92660

United States

Kaiser Permanente-Oakland

Oakland, California, 94611

United States

Children's Hospital of Orange County

Orange, California, 92868

United States

Kaiser Permanente Downtown Commons

Sacramento, California, 95814

United States

Kaiser Permanente-South Sacramento

Sacramento, California, 95823

United States

Rady Children's Hospital - San Diego

San Diego, California, 92123

United States

Kaiser Permanente-San Francisco

San Francisco, California, 94115

United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119

United States

Kaiser Permanente San Leandro

San Leandro, California, 94577

United States

Kaiser San Rafael-Gallinas

San Rafael, California, 94903

United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403

United States

City of Hope South Pasadena

South Pasadena, California, 91030

United States

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080

United States

City of Hope South Bay

Torrance, California, 90503

United States

City of Hope Upland

Upland, California, 91786

United States

Kaiser Permanente-Vallejo

Vallejo, California, 94589

United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418

United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824

United States

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, 06033

United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830

United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437

United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105

United States

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

United States

Yale University

New Haven, Connecticut, 06520

United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473

United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, 06902

United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790

United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611

United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708

United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385

United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

United States

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

Children's National Medical Center

Washington, District of Columbia, 20010

United States

Broward Health Medical Center

Fort Lauderdale, Florida, 33316

United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908

United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

United States

Nicklaus Children's Hospital

Miami, Florida, 33155

United States

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

United States

Nemours Children's Hospital

Orlando, Florida, 32827

United States

Sacred Heart Hospital

Pensacola, Florida, 32504

United States

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

United States

Tampa General Hospital

Tampa, Florida, 33606

United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607

United States

Saint Mary's Hospital

West Palm Beach, Florida, 33407

United States

Grady Health System

Atlanta, Georgia, 30303

United States

Emory Proton Therapy Center

Atlanta, Georgia, 30308

United States

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

United States

Augusta University Medical Center

Augusta, Georgia, 30912

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301

United States

Rush - Copley Medical Center

Aurora, Illinois, 60504

United States

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010

United States

Mount Sinai Hospital Medical Center

Chicago, Illinois, 60608

United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Illinois

Chicago, Illinois, 60612

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657

United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Advocate Sherman Hospital

Elgin, Illinois, 60123

United States

Elmhurst Memorial Hospital

Elmhurst, Illinois, 60126

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026

United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030

United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

AMG Libertyville - Oncology

Libertyville, Illinois, 60048

United States

Condell Memorial Hospital

Libertyville, Illinois, 60048

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

Edward Hospital/Cancer Center

Naperville, Illinois, 60540

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699

United States

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453

United States

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462

United States

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637

United States

Edward Hospital/Cancer Center?Plainfield

Plainfield, Illinois, 60585

United States

Memorial Hospital East

Shiloh, Illinois, 62269

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560

United States

Riley Hospital for Children

Indianapolis, Indiana, 46202

United States

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260

United States

Blank Children's Hospital

Des Moines, Iowa, 50309

United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

Norton Children's Hospital

Louisville, Kentucky, 40202

United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202

United States

UofL Health Medical Center Northeast

Louisville, Kentucky, 40245

United States

Children's Hospital New Orleans

New Orleans, Louisiana, 70118

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

United States

Eastern Maine Medical Center

Bangor, Maine, 04401

United States

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

United States

Bronson Battle Creek

Battle Creek, Michigan, 49017

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124

United States

Children's Hospital of Michigan

Detroit, Michigan, 48201

United States

Michigan State University Clinical Center

East Lansing, Michigan, 48824

United States

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, 48336

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503

United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503

United States

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

United States

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

United States

Ascension Borgess Cancer Center

Kalamazoo, Michigan, 49009

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444

United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444

United States

Corewell Health Reed City Hospital

Reed City, Michigan, 49677

United States

Corewell Health Children's

Royal Oak, Michigan, 48073

United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073

United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085

United States

Munson Medical Center

Traverse City, Michigan, 49684

United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085

United States

University of Michigan Health - West

Wyoming, Michigan, 49519

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Saint Luke's Hospital

Chesterfield, Missouri, 63017

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

United States

Cardinal Glennon Children's Medical Center

Saint Louis, Missouri, 63104

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135

United States

Renown Regional Medical Center

Reno, Nevada, 89502

United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

United States

Cooper Hospital University Medical Center

Camden, New Jersey, 08103

United States

Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus

Elizabeth, New Jersey, 07207

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Jersey City Medical Center

Jersey City, New Jersey, 07302

United States

Saint Barnabas Medical Center

Livingston, New Jersey, 07039

United States

Monmouth Medical Center

Long Branch, New Jersey, 07740

United States

Morristown Medical Center

Morristown, New Jersey, 07960

United States

Jersey Shore Medical Center

Neptune, New Jersey, 07753

United States

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901

United States

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Newark Beth Israel Medical Center

Newark, New Jersey, 07112

United States

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503

United States

Community Medical Center

Toms River, New Jersey, 08755

United States

Presbyterian Hospital

Albuquerque, New Mexico, 87106

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Albany Medical Center

Albany, New York, 12208

United States

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Glens Falls Hospital

Glens Falls, New York, 12801

United States

NYU Langone Hospital - Long Island

Mineola, New York, 11501

United States

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, 11040

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

NYP/Weill Cornell Medical Center

New York, New York, 10065

United States

University of Rochester

Rochester, New York, 14642

United States

Stony Brook University Medical Center

Stony Brook, New York, 11794

United States

State University of New York Upstate Medical University

Syracuse, New York, 13210

United States

Wilmot Cancer Institute at Webster

Webster, New York, 14580

United States

Mission Hospital

Asheville, North Carolina, 28801

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

United States

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

East Carolina University

Greenville, North Carolina, 27834

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Dayton Children's Hospital

Dayton, Ohio, 45404

United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

Geisinger Medical Center

Danville, Pennsylvania, 17822

United States

Penn State Children's Hospital

Hershey, Pennsylvania, 17033

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

United States

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

Smilow Cancer Hospital Care Center - Westerly

Westerly, Rhode Island, 02891

United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Prisma Health Richland Hospital

Columbia, South Carolina, 29203

United States

Saint Francis Hospital

Greenville, South Carolina, 29601

United States

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

United States

Saint Francis Cancer Center

Greenville, South Carolina, 29607

United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403

United States

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

United States

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

United States

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

United States

Driscoll Children's Hospital

Corpus Christi, Texas, 78411

United States

Medical City Dallas Hospital

Dallas, Texas, 75230

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

United States

El Paso Children's Hospital

El Paso, Texas, 79905

United States

Cook Children's Medical Center

Fort Worth, Texas, 76104

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Covenant Children's Hospital

Lubbock, Texas, 79410

United States

UMC Cancer Center / UMC Health System

Lubbock, Texas, 79415

United States

Children's Hospital of San Antonio

San Antonio, Texas, 78207

United States

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

United States

Primary Children's Hospital

Salt Lake City, Utah, 84113

United States

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

Inova Fairfax Hospital

Falls Church, Virginia, 22042

United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Carilion Children's

Roanoke, Virginia, 24014

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

United States

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405

United States

Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701

United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105

United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110

United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022

United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311

United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142

United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601

United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209

United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904

United States

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406

United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081

United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495

United States

Aurora Medical Center in Summit

Summit, Wisconsin, 53066

United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226

United States

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Kara M Kelly, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-11

Study Completion Date2031-04-28

Study Record Updates

Study Start Date2023-05-11

Study Completion Date2031-04-28

Terms related to this study

Additional Relevant MeSH Terms

Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8