Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

244

Participants

Timeline

Start Date

October 5, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Primary Mediastinal Large B-Cell Lymphoma
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood and CSF sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Etoposide Phosphate

Given IV

BIOLOGICAL

Filgrastim

Given SC

PROCEDURE

Lumbar Puncture

Undergo LP

BIOLOGICAL

Nivolumab

Given IV

BIOLOGICAL

Pegfilgrastim

Given SC

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

DRUG

Prednisolone

Given PO

DRUG

Prednisone

Given PO

RADIATION

Radiation Therapy

Undergo radiation therapy

BIOLOGICAL

Rituximab

Given IV

BIOLOGICAL

Rituximab and Hyaluronidase Human

Given SC

DRUG

Vincristine Sulfate

Given IV

Trial Locations (233)

2145

The Children's Hospital at Westmead, Westmead

2310

John Hunter Children's Hospital, Hunter Regional Mail Centre

3052

Royal Children's Hospital, Parkville

4101

Queensland Children's Hospital, South Brisbane

6009

Perth Children's Hospital, Perth

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

NYP/Weill Cornell Medical Center, New York

10467

Montefiore Medical Center - Moses Campus, The Bronx

10595

New York Medical College, Valhalla

10604

Memorial Sloan Kettering Westchester, Harrison

11040

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

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Commack, Commack

11794

Stony Brook University Medical Center, Stony Brook

12208

Albany Medical Center, Albany

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

14580

Wilmot Cancer Institute at Webster, Webster

14642

University of Rochester, Rochester

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17033

Penn State Children's Hospital, Hershey

17822

Geisinger Medical Center, Danville

18103

Lehigh Valley Hospital-Cedar Crest, Allentown

19104

Children's Hospital of Philadelphia, Philadelphia

19134

Saint Christopher's Hospital for Children, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20007

MedStar Georgetown University Hospital, Washington D.C.

20010

Children's National Medical Center, Washington D.C.

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

21204

Greater Baltimore Medical Center, Baltimore

21215

Sinai Hospital of Baltimore, Baltimore

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22042

Inova Fairfax Hospital, Falls Church

22908

University of Virginia Cancer Center, Charlottesville

23298

VCU Massey Comprehensive Cancer Center, Richmond

23507

Children's Hospital of The King's Daughters, Norfolk

24014

Carilion Children's, Roanoke

25304

West Virginia University Charleston Division, Charleston

27157

Wake Forest University Health Sciences, Winston-Salem

27834

East Carolina University, Greenville

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28204

Novant Health Presbyterian Medical Center, Charlotte

28792

AdventHealth Hendersonville, Hendersonville

28801

Mission Hospital, Asheville

28803

AdventHealth Infusion Center Asheville, Asheville

29203

Prisma Health Richland Hospital, Columbia

29601

Saint Francis Hospital, Greenville

29605

BI-LO Charities Children's Cancer Center, Greenville

29607

Saint Francis Cancer Center, Greenville

29615

Prisma Health Cancer Institute - Eastside, Greenville

30308

Emory Proton Therapy Center, Atlanta

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

30329

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta

30342

Emory Saint Joseph's Hospital, Atlanta

31404

Memorial Health University Medical Center, Savannah

32207

Nemours Children's Clinic-Jacksonville, Jacksonville

32610

University of Florida Health Science Center - Gainesville, Gainesville

32806

Arnold Palmer Hospital for Children, Orlando

32827

Nemours Children's Hospital, Orlando

33021

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood

33136

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33316

Broward Health Medical Center, Fort Lauderdale

33606

Tampa General Hospital, Tampa

33607

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

33701

Johns Hopkins All Children's Hospital, St. Petersburg

33908

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

Children's Hospital of Alabama, Birmingham

36604

USA Health Strada Patient Care Center, Mobile

37203

The Children's Hospital at TriStar Centennial, Nashville

37232

Vanderbilt University/Ingram Cancer Center, Nashville

37916

East Tennessee Childrens Hospital, Knoxville

38105

Saint Jude Children's Research Hospital, Memphis

39216

University of Mississippi Medical Center, Jackson

40202

Norton Children's Hospital, Louisville

40536

University of Kentucky/Markey Cancer Center, Lexington

43205

Nationwide Children's Hospital, Columbus

43606

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo

44106

Rainbow Babies and Childrens Hospital, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44308

Children's Hospital Medical Center of Akron, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

Dayton Children's Hospital, Dayton

45409

Greater Dayton Cancer Center, Kettering

45415

Dayton Physician LLC - Englewood, Dayton

45429

Kettering Medical Center, Kettering

46202

Riley Hospital for Children, Indianapolis

47374

Reid Health, Richmond

48073

Corewell Health Children's, Royal Oak

48109

C S Mott Children's Hospital, Ann Arbor

48201

Children's Hospital of Michigan, Detroit

48202

Henry Ford Hospital, Detroit

48823

Michigan State University, East Lansing

49007

Bronson Methodist Hospital, Kalamazoo

49120

Corewell Health Lakeland Hospitals - Niles Hospital, Niles

49503

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

50023

UI Health Care Mission Cancer and Blood - Ankeny Clinic, Ankeny

50263

UI Health Care Mission Cancer and Blood - Waukee Clinic, Waukee

50309

Blank Children's Hospital, Des Moines

50314

Mercy Medical Center - Des Moines, Des Moines

UI Health Care Mission Cancer and Blood - Laurel Clinic, Des Moines

50325

UI Health Care Mission Cancer and Blood - West Des Moines Clinic, Clive

51101

Siouxland Regional Cancer Center, Sioux City

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

54449

Marshfield Medical Center-Marshfield, Marshfield

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology PA-Maplewood, Maplewood

55337

Minnesota Oncology - Burnsville, Burnsville

55404

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis

55407

Abbott-Northwestern Hospital, Minneapolis

55416

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55432

Unity Hospital, Fridley

55433

Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

58122

Sanford Broadway Medical Center, Fargo

60045

Northwestern Medicine Lake Forest Hospital, Lake Forest

60068

Advocate Children's Hospital-Park Ridge, Park Ridge

60115

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

Northwestern Medicine Cancer Center Delnor, Geneva

60153

Loyola University Medical Center, Maywood

60453

Advocate Children's Hospital-Oak Lawn, Oak Lawn

60504

Rush-Copley Medical Center, Aurora

60555

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

Lurie Children's Hospital-Chicago, Chicago

Northwestern University, Chicago

60612

University of Illinois, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61637

Saint Jude Midwest Affiliate, Peoria

61801

Carle Cancer Center, Urbana

61832

Carle at The Riverfront, Danville

61938

Carle Physician Group-Mattoon/Charleston, Mattoon

62269

HSHS Saint Elizabeth's Hospital, O'Fallon

62401

Carle Physician Group-Effingham, Effingham

62526

Decatur Memorial Hospital, Decatur

62702

Southern Illinois University School of Medicine, Springfield

Springfield Clinic, Springfield

62781

Springfield Memorial Hospital, Springfield

63017

Saint Luke's Hospital, Chesterfield

63110

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center-South County, St Louis

63136

Siteman Cancer Center at Christian Hospital, St Louis

63141

Siteman Cancer Center at West County Hospital, Creve Coeur

Mercy Hospital Saint Louis, St Louis

63376

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

64108

Children's Mercy Hospitals and Clinics, Kansas City

67214

Wesley Medical Center, Wichita

68114

Children's Hospital and Medical Center of Omaha, Omaha

68198

University of Nebraska Medical Center, Omaha

70118

Children's Hospital New Orleans, New Orleans

70121

Ochsner Medical Center Jefferson, New Orleans

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75230

Medical City Dallas Hospital, Dallas

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

77030

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

Houston Methodist Hospital, Houston

M D Anderson Cancer Center, Houston

78207

Children's Hospital of San Antonio, San Antonio

78229

Methodist Children's Hospital of South Texas, San Antonio

University of Texas Health Science Center at San Antonio, San Antonio

78411

Driscoll Children's Hospital, Corpus Christi

78723

Dell Children's Medical Center of Central Texas, Austin

79106

Texas Tech University Health Sciences Center-Amarillo, Amarillo

79410

Covenant Children's Hospital, Lubbock

79415

UMC Cancer Center / UMC Health System, Lubbock

79905

El Paso Children's Hospital, El Paso

80045

Children's Hospital Colorado, Aurora

80218

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver

83712

Saint Luke's Cancer Institute - Boise, Boise

84113

Primary Children's Hospital, Salt Lake City

85202

Banner Children's at Desert, Mesa

85719

Banner University Medical Center - Tucson, Tucson

87106

Presbyterian Hospital, Albuquerque

89135

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas

89502

Renown Regional Medical Center, Reno

90027

Children's Hospital Los Angeles, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

90095

Mattel Children's Hospital UCLA, Los Angeles

90242

Kaiser Permanente Downey Medical Center, Downey

90806

Miller Children's and Women's Hospital Long Beach, Long Beach

91010

City of Hope Comprehensive Cancer Center, Duarte

92123

Rady Children's Hospital - San Diego, San Diego

92354

Loma Linda University Medical Center, Loma Linda

92612

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine

92618

City of Hope at Irvine Lennar, Irvine

92627

UC Irvine Health Cancer Center-Newport, Costa Mesa

92868

Children's Hospital of Orange County, Orange

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

93636

Valley Children's Hospital, Madera

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

94611

Kaiser Permanente-Oakland, Oakland

95817

University of California Davis Comprehensive Cancer Center, Sacramento

96826

Kapiolani Medical Center for Women and Children, Honolulu

97227

Legacy Emanuel Children's Hospital, Portland

97239

Oregon Health and Science University, Portland

98055

Valley Medical Center, Renton

98105

Seattle Children's Hospital, Seattle

98405

Mary Bridge Children's Hospital and Health Center, Tacoma

98431

Madigan Army Medical Center, Tacoma

99204

Providence Sacred Heart Medical Center and Children's Hospital, Spokane

99508

Providence Alaska Medical Center, Anchorage

72202-3591

Arkansas Children's Hospital, Little Rock

06106

Connecticut Children's Medical Center, Hartford

04401

Eastern Maine Medical Center, Bangor

04074

Maine Children's Cancer Program, Scarborough

20889-5600

Walter Reed National Military Medical Center, Bethesda

02111

Tufts Medical Center, Boston

02215

Dana-Farber Cancer Institute, Boston

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07601

Hackensack University Medical Center, Hackensack

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

07960

Morristown Medical Center, Morristown

08903

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

Rutgers Cancer Institute of New Jersey, New Brunswick

07503

Saint Joseph's Regional Medical Center, Paterson

02903

Rhode Island Hospital, Providence

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

T6G 2B7

University of Alberta Hospital, Edmonton

R3E 0V9

CancerCare Manitoba, Winnipeg

A1B 3V6

Janeway Child Health Centre, St. John's

B3K 6R8

IWK Health Centre, Halifax

L8N 3Z5

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

N6A 5W9

Children's Hospital, London

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

Hospital for Sick Children, Toronto

H3H 1P3

The Montreal Children's Hospital of the MUHC, Montreal

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke

G1V 4G2

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL), Québec

00726

HIMA San Pablo Oncologic Hospital, Caguas

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH