Actively Recruiting

Phase 2
Age: 1Year - 30Years
All Genders
NCT04546399

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

Led by National Cancer Institute (NCI) · Updated on 2025-09-10

461

Participants Needed

215

Research Sites

393 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be >= 1 and < 31 years at time of enrollment

  • Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:

    • Isolated bone marrow relapse
    • Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
    • Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes
  • Patients with Down syndrome (DS) are eligible in the following categories:

    • Isolated bone marrow relapse
    • Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

    • Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

    • Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression

    • Patients must not have had a prior hematopoietic stem cell transplant

    • A single intrathecal chemotherapy at the time of relapse will be allowed. If < 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted

    • In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and/or hydroxyurea only) is permissible

      • Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) >= 30,000/ul at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no "washout" is required
      • Patients with Down syndrome who received pre-enrollment therapy and have a WBC < 30,000/ul at the time of enrollment must be given a 24 hour "washout" before starting immunotherapy
    • Note: There is no waiting period or "washout" for patients who relapse while receiving upfront therapy

  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/sex as follows (within 7 calendar days prior to enrollment):

    • Age: Maximum serum creatinine (mg/dL)

      • 1 to < 2 years: 0.6 (male), 0.6 (female)

      • 2 to < 6 years: 0.8 (male), 0.8 (female)

      • 6 to < 10 years: 1 (male), 1 (female)

      • 10 to < 13 years: 1.2 (male), 1.2 (female)

      • 13 to < 16 years: 1.5 (male), 1.4 (female)

      • >= 16 years: 1.7 (male), 1.4 (female)

        • The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC)
  • Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram

  • No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination

  • 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

Not Eligible

You will not qualify if you...

  • Patients with B-lymphoblastic lymphoma (B-LLy)

  • Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia

  • Patients with Philadelphia chromosome positive (Ph+) B-ALL

  • Patients with mixed phenotype acute leukemia (MPAL)

  • Patients with known Charcot-Marie-Tooth disease

  • Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype

  • Patients with active, uncontrolled infection defined as:

    • Positive bacterial blood culture within 48 hours of study enrollment
    • Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline.
    • Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for > 48 hours
    • A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection
    • Active viral or protozoal infection requiring IV treatment
  • Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible.

  • Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible

  • Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement

    • Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved
  • Patients with an active known/suspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll

  • Group 4 and patients with DS patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are not eligible

    • Note: Group 3 patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab

  • Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 215 locations

1

Children's Hospital of Alabama

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

USA Health Strada Patient Care Center

Mobile, Alabama, United States, 36604

Actively Recruiting

3

Providence Alaska Medical Center

Anchorage, Alaska, United States, 99508

Suspended

4

Kingman Regional Medical Center

Kingman, Arizona, United States, 86401

Suspended

5

Banner Children's at Desert

Mesa, Arizona, United States, 85202

Actively Recruiting

6

Phoenix Childrens Hospital

Phoenix, Arizona, United States, 85016

Actively Recruiting

7

Banner University Medical Center - Tucson

Tucson, Arizona, United States, 85719

Actively Recruiting

8

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202-3591

Actively Recruiting

9

Kaiser Permanente-Anaheim

Anaheim, California, United States, 92806

Actively Recruiting

10

PCR Oncology

Arroyo Grande, California, United States, 93420

Suspended

11

Kaiser Permanente-Bellflower

Bellflower, California, United States, 90706

Suspended

12

Kaiser Permanente Downey Medical Center

Downey, California, United States, 90242

Actively Recruiting

13

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

Active, Not Recruiting

14

Kaiser Permanente-Fontana

Fontana, California, United States, 92335

Actively Recruiting

15

Loma Linda University Medical Center

Loma Linda, California, United States, 92354

Actively Recruiting

16

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

17

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States, 90027

Suspended

18

Cedars Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

19

Mattel Children's Hospital UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

20

Valley Children's Hospital

Madera, California, United States, 93636

Actively Recruiting

21

Kaiser Permanente-Oakland

Oakland, California, United States, 94611

Actively Recruiting

22

Children's Hospital of Orange County

Orange, California, United States, 92868

Actively Recruiting

23

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States, 94304

Actively Recruiting

24

Sutter Medical Center Sacramento

Sacramento, California, United States, 95816

Actively Recruiting

25

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Actively Recruiting

26

Kaiser Permanente-San Diego Zion

San Diego, California, United States, 92120

Actively Recruiting

27

Rady Children's Hospital - San Diego

San Diego, California, United States, 92123

Actively Recruiting

28

UCSF Medical Center-Mission Bay

San Francisco, California, United States, 94158

Actively Recruiting

29

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States, 90502

Active, Not Recruiting

30

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

31

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

Denver, Colorado, United States, 80218

Actively Recruiting

32

Connecticut Children's Medical Center

Hartford, Connecticut, United States, 06106

Actively Recruiting

33

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

34

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States, 19803

Actively Recruiting

35

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

36

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States, 33908

Actively Recruiting

37

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States, 32610

Actively Recruiting

38

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States, 33021

Actively Recruiting

39

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States, 32207

Actively Recruiting

40

AdventHealth Orlando

Orlando, Florida, United States, 32803

Actively Recruiting

41

Arnold Palmer Hospital for Children

Orlando, Florida, United States, 32806

Actively Recruiting

42

Nemours Children's Hospital

Orlando, Florida, United States, 32827

Actively Recruiting

43

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States, 32504

Actively Recruiting

44

Sacred Heart Hospital

Pensacola, Florida, United States, 32504

Suspended

45

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States, 33701

Actively Recruiting

46

Tampa General Hospital

Tampa, Florida, United States, 33606

Actively Recruiting

47

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

Tampa, Florida, United States, 33607

Actively Recruiting

48

Saint Mary's Medical Center

West Palm Beach, Florida, United States, 33407

Actively Recruiting

49

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States, 30329

Actively Recruiting

50

Memorial Health University Medical Center

Savannah, Georgia, United States, 31404

Actively Recruiting

51

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States, 96826

Actively Recruiting

52

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States, 83712

Actively Recruiting

53

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

54

University of Illinois

Chicago, Illinois, United States, 60612

Actively Recruiting

55

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

56

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Actively Recruiting

57

Saint Jude Midwest Affiliate

Peoria, Illinois, United States, 61637

Actively Recruiting

58

Riley Hospital for Children

Indianapolis, Indiana, United States, 46202

Actively Recruiting

59

Blank Children's Hospital

Des Moines, Iowa, United States, 50309

Actively Recruiting

60

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States, 52242

Actively Recruiting

61

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States, 40536

Actively Recruiting

62

Norton Children's Hospital

Louisville, Kentucky, United States, 40202

Actively Recruiting

63

Children's Hospital New Orleans

New Orleans, Louisiana, United States, 70118

Actively Recruiting

64

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States, 70121

Active, Not Recruiting

65

Maine Children's Cancer Program

Scarborough, Maine, United States, 04074

Actively Recruiting

66

Sinai Hospital of Baltimore

Baltimore, Maryland, United States, 21215

Actively Recruiting

67

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States, 21287

Actively Recruiting

68

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889-5600

Active, Not Recruiting

69

Tufts Children's Hospital

Boston, Massachusetts, United States, 02111

Active, Not Recruiting

70

C S Mott Children's Hospital

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

71

Bronson Battle Creek

Battle Creek, Michigan, United States, 49017

Suspended

72

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States, 48124

Suspended

73

Children's Hospital of Michigan

Detroit, Michigan, United States, 48201

Actively Recruiting

74

Michigan State University

East Lansing, Michigan, United States, 48823

Active, Not Recruiting

75

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States, 49503

Suspended

76

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

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

77

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States, 49503

Suspended

78

Bronson Methodist Hospital

Kalamazoo, Michigan, United States, 49007

Suspended

79

West Michigan Cancer Center

Kalamazoo, Michigan, United States, 49007

Suspended

80

Beacon Kalamazoo

Kalamazoo, Michigan, United States, 49048

Suspended

81

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States, 49444

Suspended

82

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States, 49120

Suspended

83

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States, 49444

Suspended

84

Corewell Health Reed City Hospital

Reed City, Michigan, United States, 49677

Suspended

85

Corewell Health Children's

Royal Oak, Michigan, United States, 48073

Actively Recruiting

86

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States, 48073

Suspended

87

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States, 49085

Suspended

88

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States, 49085

Suspended

89

Munson Medical Center

Traverse City, Michigan, United States, 49684

Suspended

90

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States, 48085

Suspended

91

University of Michigan Health - West

Wyoming, Michigan, United States, 49519

Suspended

92

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

93

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

94

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

Actively Recruiting

95

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States, 64108

Actively Recruiting

96

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States, 63104

Actively Recruiting

97

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

98

Mercy Hospital Saint Louis

St Louis, Missouri, United States, 63141

Actively Recruiting

99

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States, 68114

Actively Recruiting

100

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

101

Carson Tahoe Regional Medical Center

Carson City, Nevada, United States, 89703

Suspended

102

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States, 89052

Suspended

103

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States, 89052

Suspended

104

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States, 89052

Suspended

105

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States, 89052

Suspended

106

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States, 89074

Suspended

107

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States, 89102

Suspended

108

Hope Cancer Care of Nevada

Las Vegas, Nevada, United States, 89103

Suspended

109

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States, 89109

Suspended

110

Ann M Wierman MD LTD

Las Vegas, Nevada, United States, 89128

Suspended

111

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, United States, 89128

Suspended

112

OptumCare Cancer Care at MountainView

Las Vegas, Nevada, United States, 89128

Suspended

113

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States, 89135

Actively Recruiting

114

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, United States, 89144

Suspended

115

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States, 89144

Suspended

116

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States, 89144

Actively Recruiting

117

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, United States, 89148-2405

Suspended

118

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89148

Suspended

119

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States, 89148

Suspended

120

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States, 89169

Suspended

121

Hope Cancer Care of Nevada-Pahrump

Pahrump, Nevada, United States, 89048

Suspended

122

Renown Regional Medical Center

Reno, Nevada, United States, 89502

Actively Recruiting

123

Saint Mary's Regional Medical Center

Reno, Nevada, United States, 89503

Suspended

124

Cancer Care Specialists - Reno

Reno, Nevada, United States, 89511

Suspended

125

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

126

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Actively Recruiting

127

Morristown Medical Center

Morristown, New Jersey, United States, 07960

Actively Recruiting

128

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

New Brunswick, New Jersey, United States, 08903

Actively Recruiting

129

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

Actively Recruiting

130

Newark Beth Israel Medical Center

Newark, New Jersey, United States, 07112

Actively Recruiting

131

Saint Joseph's Regional Medical Center

Paterson, New Jersey, United States, 07503

Actively Recruiting

132

Albany Medical Center

Albany, New York, United States, 12208

Actively Recruiting

133

Maimonides Medical Center

Brooklyn, New York, United States, 11219

Actively Recruiting

134

NYU Langone Hospital - Long Island

Mineola, New York, United States, 11501

Actively Recruiting

135

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

New Hyde Park, New York, United States, 11040

Actively Recruiting

136

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States, 10016

Actively Recruiting

137

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

New York, New York, United States, 10032

Actively Recruiting

138

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

139

University of Rochester

Rochester, New York, United States, 14642

Active, Not Recruiting

140

Stony Brook University Medical Center

Stony Brook, New York, United States, 11794

Actively Recruiting

141

State University of New York Upstate Medical University

Syracuse, New York, United States, 13210

Actively Recruiting

142

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States, 10467

Actively Recruiting

143

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

144

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States, 28203

Actively Recruiting

145

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

146

East Carolina University

Greenville, North Carolina, United States, 27834

Actively Recruiting

147

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

148

Sanford Broadway Medical Center

Fargo, North Dakota, United States, 58122

Actively Recruiting

149

Children's Hospital Medical Center of Akron

Akron, Ohio, United States, 44308

Actively Recruiting

150

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

151

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States, 44106

Actively Recruiting

152

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Suspended

153

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

154

Dayton Children's Hospital

Dayton, Ohio, United States, 45404

Actively Recruiting

155

ProMedica Flower Hospital

Sylvania, Ohio, United States, 43560

Suspended

156

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, United States, 43606

Actively Recruiting

157

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

158

Legacy Emanuel Children's Hospital

Portland, Oregon, United States, 97227

Actively Recruiting

159

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

160

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States, 18103

Actively Recruiting

161

Geisinger Medical Center

Danville, Pennsylvania, United States, 17822

Actively Recruiting

162

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

163

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States, 19134

Actively Recruiting

164

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

165

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

166

Prisma Health Richland Hospital

Columbia, South Carolina, United States, 29203

Actively Recruiting

167

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, United States, 29605

Actively Recruiting

168

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States, 29615

Actively Recruiting

169

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States, 57117-5134

Actively Recruiting

170

East Tennessee Childrens Hospital

Knoxville, Tennessee, United States, 37916

Actively Recruiting

171

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, United States, 37203

Actively Recruiting

172

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

173

Dell Children's Medical Center of Central Texas

Austin, Texas, United States, 78723

Actively Recruiting

174

Driscoll Children's Hospital

Corpus Christi, Texas, United States, 78411

Actively Recruiting

175

Medical City Dallas Hospital

Dallas, Texas, United States, 75230

Actively Recruiting

176

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States, 75390

Actively Recruiting

177

El Paso Children's Hospital

El Paso, Texas, United States, 79905

Actively Recruiting

178

Cook Children's Medical Center

Fort Worth, Texas, United States, 76104

Actively Recruiting

179

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

180

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

181

Covenant Children's Hospital

Lubbock, Texas, United States, 79410

Actively Recruiting

182

UMC Cancer Center / UMC Health System

Lubbock, Texas, United States, 79415

Actively Recruiting

183

Children's Hospital of San Antonio

San Antonio, Texas, United States, 78207

Actively Recruiting

184

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States, 78229

Actively Recruiting

185

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

186

Primary Children's Hospital

Salt Lake City, Utah, United States, 84113

Actively Recruiting

187

University of Vermont and State Agricultural College

Burlington, Vermont, United States, 05405

Actively Recruiting

188

Inova Fairfax Hospital

Falls Church, Virginia, United States, 22042

Actively Recruiting

189

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States, 23507

Actively Recruiting

190

Overlake Medical Center

Bellevue, Washington, United States, 98004

Suspended

191

Valley Medical Center

Renton, Washington, United States, 98055

Suspended

192

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

193

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States, 99204

Actively Recruiting

194

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, United States, 98405

Actively Recruiting

195

Madigan Army Medical Center

Tacoma, Washington, United States, 98431

Actively Recruiting

196

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, United States, 98902

Suspended

197

United Hospital Center

Bridgeport, West Virginia, United States, 26330

Suspended

198

WVUH-Berkely Medical Center

Martinsburg, West Virginia, United States, 25401

Suspended

199

West Virginia University Healthcare

Morgantown, West Virginia, United States, 26506

Suspended

200

Camden Clark Medical Center

Parkersburg, West Virginia, United States, 26101

Suspended

201

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States, 53792

Active, Not Recruiting

202

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

203

John Hunter Children's Hospital

Hunter Regional Mail Centre, New South Wales, Australia, 2310

Suspended

204

Sydney Children's Hospital

Randwick, New South Wales, Australia, 2031

Suspended

205

The Children's Hospital at Westmead

Westmead, New South Wales, Australia, 2145

Suspended

206

Queensland Children's Hospital

South Brisbane, Queensland, Australia, 4101

Suspended

207

Perth Children's Hospital

Perth, Western Australia, Australia, 6009

Suspended

208

CancerCare Manitoba

Winnipeg, Manitoba, Canada, R3E 0V9

Suspended

209

Janeway Child Health Centre

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Suspended

210

IWK Health Centre

Halifax, Nova Scotia, Canada, B3K 6R8

Suspended

211

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, Canada, H3H 1P3

Actively Recruiting

212

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

213

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

214

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

Québec, Canada, G1V 4G2

Actively Recruiting

215

University Pediatric Hospital

San Juan, Puerto Rico, 00926

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

9

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