A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

PHASE2RecruitingINTERVENTIONAL
Enrollment

461

Participants

Timeline

Start Date

December 17, 2020

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Down SyndromeRecurrent B Acute Lymphoblastic Leukemia
Interventions
RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D-CRT

PROCEDURE

Biospecimen Collection

Undergo blood, urine and cerebrospinal fluid collection

BIOLOGICAL

Blinatumomab

Given IV

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Calaspargase Pegol

Given IV

DRUG

Cytarabine

Given IT

DRUG

Dexamethasone

Given PO or IV

DRUG

Hydrocortisone Sodium Succinate

Given IT

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, PO, and IV

BIOLOGICAL

Nivolumab

Given IV

DRUG

Pegaspargase

Given IM or IV

DRUG

Pegcrisantaspase

Given IM or IV

DRUG

Vincristine Sulfate

Given IV push or via infusion

Trial Locations (215)

2031

SUSPENDED

Sydney Children's Hospital, Randwick

2145

SUSPENDED

The Children's Hospital at Westmead, Westmead

2310

SUSPENDED

John Hunter Children's Hospital, Hunter Regional Mail Centre

4101

SUSPENDED

Queensland Children's Hospital, South Brisbane

6009

SUSPENDED

Perth Children's Hospital, Perth

10016

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10032

RECRUITING

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

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10467

RECRUITING

Montefiore Medical Center - Moses Campus, The Bronx

11040

RECRUITING

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

11219

RECRUITING

Maimonides Medical Center, Brooklyn

11501

RECRUITING

NYU Langone Hospital - Long Island, Mineola

11794

RECRUITING

Stony Brook University Medical Center, Stony Brook

12208

RECRUITING

Albany Medical Center, Albany

13210

RECRUITING

State University of New York Upstate Medical University, Syracuse

14642

ACTIVE_NOT_RECRUITING

University of Rochester, Rochester

15224

RECRUITING

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17822

RECRUITING

Geisinger Medical Center, Danville

18103

RECRUITING

Lehigh Valley Hospital-Cedar Crest, Allentown

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19134

RECRUITING

Saint Christopher's Hospital for Children, Philadelphia

19803

RECRUITING

Alfred I duPont Hospital for Children, Wilmington

20010

RECRUITING

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

21215

RECRUITING

Sinai Hospital of Baltimore, Baltimore

21287

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22042

RECRUITING

Inova Fairfax Hospital, Falls Church

23507

RECRUITING

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

25401

SUSPENDED

WVUH-Berkely Medical Center, Martinsburg

26101

SUSPENDED

Camden Clark Medical Center, Parkersburg

26330

SUSPENDED

United Hospital Center, Bridgeport

26506

SUSPENDED

West Virginia University Healthcare, Morgantown

27157

RECRUITING

Wake Forest University Health Sciences, Winston-Salem

27599

RECRUITING

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

RECRUITING

Duke University Medical Center, Durham

27834

RECRUITING

East Carolina University, Greenville

28203

RECRUITING

Carolinas Medical Center/Levine Cancer Institute, Charlotte

29203

RECRUITING

Prisma Health Richland Hospital, Columbia

29605

RECRUITING

BI-LO Charities Children's Cancer Center, Greenville

29615

RECRUITING

Prisma Health Cancer Institute - Eastside, Greenville

30329

RECRUITING

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

31404

RECRUITING

Memorial Health University Medical Center, Savannah

32207

RECRUITING

Nemours Children's Clinic-Jacksonville, Jacksonville

32504

RECRUITING

Nemours Children's Clinic - Pensacola, Pensacola

SUSPENDED

Sacred Heart Hospital, Pensacola

32610

RECRUITING

University of Florida Health Science Center - Gainesville, Gainesville

32803

RECRUITING

AdventHealth Orlando, Orlando

32806

RECRUITING

Arnold Palmer Hospital for Children, Orlando

32827

RECRUITING

Nemours Children's Hospital, Orlando

33021

RECRUITING

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

33407

RECRUITING

Saint Mary's Medical Center, West Palm Beach

33606

RECRUITING

Tampa General Hospital, Tampa

33607

RECRUITING

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

33701

RECRUITING

Johns Hopkins All Children's Hospital, St. Petersburg

33908

RECRUITING

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

RECRUITING

Children's Hospital of Alabama, Birmingham

36604

RECRUITING

USA Health Strada Patient Care Center, Mobile

37203

RECRUITING

The Children's Hospital at TriStar Centennial, Nashville

37232

RECRUITING

Vanderbilt University/Ingram Cancer Center, Nashville

37916

RECRUITING

East Tennessee Childrens Hospital, Knoxville

39216

RECRUITING

University of Mississippi Medical Center, Jackson

40202

RECRUITING

Norton Children's Hospital, Louisville

40536

RECRUITING

University of Kentucky/Markey Cancer Center, Lexington

43205

RECRUITING

Nationwide Children's Hospital, Columbus

43560

SUSPENDED

ProMedica Flower Hospital, Sylvania

43606

RECRUITING

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

44106

RECRUITING

Rainbow Babies and Childrens Hospital, Cleveland

44195

SUSPENDED

Cleveland Clinic Foundation, Cleveland

44308

RECRUITING

Children's Hospital Medical Center of Akron, Akron

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

RECRUITING

Dayton Children's Hospital, Dayton

46202

RECRUITING

Riley Hospital for Children, Indianapolis

48073

RECRUITING

Corewell Health Children's, Royal Oak

SUSPENDED

Corewell Health William Beaumont University Hospital, Royal Oak

48085

SUSPENDED

Corewell Health Beaumont Troy Hospital, Troy

48109

RECRUITING

C S Mott Children's Hospital, Ann Arbor

48124

SUSPENDED

Corewell Health Dearborn Hospital, Dearborn

48201

RECRUITING

Children's Hospital of Michigan, Detroit

48823

ACTIVE_NOT_RECRUITING

Michigan State University, East Lansing

49007

SUSPENDED

Bronson Methodist Hospital, Kalamazoo

SUSPENDED

West Michigan Cancer Center, Kalamazoo

49017

SUSPENDED

Bronson Battle Creek, Battle Creek

49048

SUSPENDED

Beacon Kalamazoo, Kalamazoo

49085

SUSPENDED

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center, Saint Joseph

SUSPENDED

Corewell Health Lakeland Hospitals - Saint Joseph Hospital, Saint Joseph

49120

SUSPENDED

Corewell Health Lakeland Hospitals - Niles Hospital, Niles

49444

SUSPENDED

Trinity Health Muskegon Hospital, Muskegon

SUSPENDED

Cancer and Hematology Centers of Western Michigan - Norton Shores, Norton Shores

49503

SUSPENDED

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

RECRUITING

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

SUSPENDED

Trinity Health Grand Rapids Hospital, Grand Rapids

49519

SUSPENDED

University of Michigan Health - West, Wyoming

49677

SUSPENDED

Corewell Health Reed City Hospital, Reed City

49684

SUSPENDED

Munson Medical Center, Traverse City

50309

RECRUITING

Blank Children's Hospital, Des Moines

52242

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53226

RECRUITING

Children's Hospital of Wisconsin, Milwaukee

53792

ACTIVE_NOT_RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

55404

RECRUITING

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

55455

RECRUITING

University of Minnesota/Masonic Cancer Center, Minneapolis

58122

RECRUITING

Sanford Broadway Medical Center, Fargo

60153

RECRUITING

Loyola University Medical Center, Maywood

60611

RECRUITING

Lurie Children's Hospital-Chicago, Chicago

60612

RECRUITING

University of Illinois, Chicago

60637

RECRUITING

University of Chicago Comprehensive Cancer Center, Chicago

61637

RECRUITING

Saint Jude Midwest Affiliate, Peoria

63104

RECRUITING

Cardinal Glennon Children's Medical Center, St Louis

63110

RECRUITING

Washington University School of Medicine, St Louis

63141

RECRUITING

Mercy Hospital Saint Louis, St Louis

64108

RECRUITING

Children's Mercy Hospitals and Clinics, Kansas City

68114

RECRUITING

Children's Hospital and Medical Center of Omaha, Omaha

68198

RECRUITING

University of Nebraska Medical Center, Omaha

70118

RECRUITING

Children's Hospital New Orleans, New Orleans

70121

ACTIVE_NOT_RECRUITING

Ochsner Medical Center Jefferson, New Orleans

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

75230

RECRUITING

Medical City Dallas Hospital, Dallas

75390

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

RECRUITING

Cook Children's Medical Center, Fort Worth

77030

RECRUITING

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

RECRUITING

M D Anderson Cancer Center, Houston

78207

RECRUITING

Children's Hospital of San Antonio, San Antonio

78229

RECRUITING

Methodist Children's Hospital of South Texas, San Antonio

RECRUITING

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

78411

RECRUITING

Driscoll Children's Hospital, Corpus Christi

78723

RECRUITING

Dell Children's Medical Center of Central Texas, Austin

79410

RECRUITING

Covenant Children's Hospital, Lubbock

79415

RECRUITING

UMC Cancer Center / UMC Health System, Lubbock

79905

RECRUITING

El Paso Children's Hospital, El Paso

80045

RECRUITING

Children's Hospital Colorado, Aurora

80218

RECRUITING

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

83712

RECRUITING

Saint Luke's Cancer Institute - Boise, Boise

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

85016

RECRUITING

Phoenix Childrens Hospital, Phoenix

85202

RECRUITING

Banner Children's at Desert, Mesa

85719

RECRUITING

Banner University Medical Center - Tucson, Tucson

86401

SUSPENDED

Kingman Regional Medical Center, Kingman

89048

SUSPENDED

Hope Cancer Care of Nevada-Pahrump, Pahrump

89052

SUSPENDED

Comprehensive Cancer Centers of Nevada - Henderson, Henderson

SUSPENDED

Comprehensive Cancer Centers of Nevada-Horizon Ridge, Henderson

SUSPENDED

Las Vegas Cancer Center-Henderson, Henderson

SUSPENDED

OptumCare Cancer Care at Seven Hills, Henderson

89074

SUSPENDED

Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson

89102

SUSPENDED

OptumCare Cancer Care at Charleston, Las Vegas

89103

SUSPENDED

Hope Cancer Care of Nevada, Las Vegas

89109

SUSPENDED

Sunrise Hospital and Medical Center, Las Vegas

89128

SUSPENDED

Ann M Wierman MD LTD, Las Vegas

SUSPENDED

Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas

SUSPENDED

OptumCare Cancer Care at MountainView, Las Vegas

89135

RECRUITING

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

89144

SUSPENDED

Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas

SUSPENDED

Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas

RECRUITING

Summerlin Hospital Medical Center, Las Vegas

89148

SUSPENDED

Comprehensive Cancer Centers of Nevada, Las Vegas

SUSPENDED

OptumCare Cancer Care at Fort Apache, Las Vegas

89169

SUSPENDED

Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas

89502

RECRUITING

Renown Regional Medical Center, Reno

89503

SUSPENDED

Saint Mary's Regional Medical Center, Reno

89511

SUSPENDED

Cancer Care Specialists - Reno, Reno

89703

SUSPENDED

Carson Tahoe Regional Medical Center, Carson City

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

SUSPENDED

Kaiser Permanente Los Angeles Medical Center, Los Angeles

90048

RECRUITING

Cedars Sinai Medical Center, Los Angeles

90095

RECRUITING

Mattel Children's Hospital UCLA, Los Angeles

90242

RECRUITING

Kaiser Permanente Downey Medical Center, Downey

90502

ACTIVE_NOT_RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

90706

SUSPENDED

Kaiser Permanente-Bellflower, Bellflower

91010

ACTIVE_NOT_RECRUITING

City of Hope Comprehensive Cancer Center, Duarte

92120

RECRUITING

Kaiser Permanente-San Diego Zion, San Diego

92123

RECRUITING

Rady Children's Hospital - San Diego, San Diego

92335

RECRUITING

Kaiser Permanente-Fontana, Fontana

92354

RECRUITING

Loma Linda University Medical Center, Loma Linda

92806

RECRUITING

Kaiser Permanente-Anaheim, Anaheim

92868

RECRUITING

Children's Hospital of Orange County, Orange

93420

SUSPENDED

PCR Oncology, Arroyo Grande

93636

RECRUITING

Valley Children's Hospital, Madera

94158

RECRUITING

UCSF Medical Center-Mission Bay, San Francisco

94304

RECRUITING

Lucile Packard Children's Hospital Stanford University, Palo Alto

94611

RECRUITING

Kaiser Permanente-Oakland, Oakland

95816

RECRUITING

Sutter Medical Center Sacramento, Sacramento

95817

RECRUITING

University of California Davis Comprehensive Cancer Center, Sacramento

96826

RECRUITING

Kapiolani Medical Center for Women and Children, Honolulu

97227

RECRUITING

Legacy Emanuel Children's Hospital, Portland

97239

RECRUITING

Oregon Health and Science University, Portland

98004

SUSPENDED

Overlake Medical Center, Bellevue

98055

SUSPENDED

Valley Medical Center, Renton

98105

RECRUITING

Seattle Children's Hospital, Seattle

98405

RECRUITING

Mary Bridge Children's Hospital and Health Center, Tacoma

98431

RECRUITING

Madigan Army Medical Center, Tacoma

98902

SUSPENDED

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima

99204

RECRUITING

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

99508

SUSPENDED

Providence Alaska Medical Center, Anchorage

72202-3591

RECRUITING

Arkansas Children's Hospital, Little Rock

06106

RECRUITING

Connecticut Children's Medical Center, Hartford

06520

RECRUITING

Yale University, New Haven

04074

RECRUITING

Maine Children's Cancer Program, Scarborough

20889-5600

ACTIVE_NOT_RECRUITING

Walter Reed National Military Medical Center, Bethesda

02111

ACTIVE_NOT_RECRUITING

Tufts Children's Hospital, Boston

89148-2405

SUSPENDED

Las Vegas Cancer Center-Medical Center, Las Vegas

03756

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07601

RECRUITING

Hackensack University Medical Center, Hackensack

07960

RECRUITING

Morristown Medical Center, Morristown

08903

RECRUITING

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

RECRUITING

Rutgers Cancer Institute of New Jersey, New Brunswick

07112

RECRUITING

Newark Beth Israel Medical Center, Newark

07503

RECRUITING

Saint Joseph's Regional Medical Center, Paterson

02903

RECRUITING

Rhode Island Hospital, Providence

57117-5134

RECRUITING

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05405

RECRUITING

University of Vermont and State Agricultural College, Burlington

R3E 0V9

SUSPENDED

CancerCare Manitoba, Winnipeg

A1B 3V6

SUSPENDED

Janeway Child Health Centre, St. John's

B3K 6R8

SUSPENDED

IWK Health Centre, Halifax

H3H 1P3

RECRUITING

The Montreal Children's Hospital of the MUHC, Montreal

H3T 1C5

RECRUITING

Centre Hospitalier Universitaire Sainte-Justine, Montreal

J1H 5N4

RECRUITING

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke

G1V 4G2

RECRUITING

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

00926

RECRUITING

University Pediatric Hospital, San Juan

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH