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ClinicalTrials.gov record
Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT04546399

Public ClinicalTrials.gov record NCT04546399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 19, 2026, 8:32 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse

Study identification

NCT ID
NCT04546399
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
National Cancer Institute (NCI)
NIH
Enrollment
461 participants

Conditions and interventions

Interventions

  • 3-Dimensional Conformal Radiation Therapy Radiation
  • Biospecimen Collection Procedure
  • Blinatumomab Biological
  • Bone Marrow Aspiration Procedure
  • Bone Marrow Biopsy Procedure
  • Calaspargase Pegol Drug
  • Cytarabine Drug
  • Dexamethasone Drug
  • Hydrocortisone Sodium Succinate Drug
  • Lumbar Puncture Procedure
  • Mercaptopurine Drug
  • Methotrexate Drug
  • Nivolumab Biological
  • Pegaspargase Drug
  • Pegcrisantaspase Drug
  • Vincristine Sulfate Drug

Radiation · Procedure · Biological + 1 more

Eligibility (public fields only)

Age range
1 Year to 30 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 16, 2020
Primary completion
Jun 29, 2028
Completion
Jun 29, 2028
Last update posted
Sep 9, 2025

2020 – 2028

United States locations

U.S. sites
202
U.S. states
47
U.S. cities
146
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233 Recruiting
USA Health Strada Patient Care Center Mobile Alabama 36604 Recruiting
Providence Alaska Medical Center Anchorage Alaska 99508 Suspended
Kingman Regional Medical Center Kingman Arizona 86401 Suspended
Banner Children's at Desert Mesa Arizona 85202 Recruiting
Phoenix Childrens Hospital Phoenix Arizona 85016 Recruiting
Banner University Medical Center - Tucson Tucson Arizona 85719 Recruiting
Arkansas Children's Hospital Little Rock Arkansas 72202-3591 Recruiting
Kaiser Permanente-Anaheim Anaheim California 92806 Recruiting
PCR Oncology Arroyo Grande California 93420 Suspended
Kaiser Permanente-Bellflower Bellflower California 90706 Suspended
Kaiser Permanente Downey Medical Center Downey California 90242 Recruiting
City of Hope Comprehensive Cancer Center Duarte California 91010 Active, not recruiting
Kaiser Permanente-Fontana Fontana California 92335 Recruiting
Loma Linda University Medical Center Loma Linda California 92354 Recruiting
Children's Hospital Los Angeles Los Angeles California 90027 Recruiting
Kaiser Permanente Los Angeles Medical Center Los Angeles California 90027 Suspended
Cedars Sinai Medical Center Los Angeles California 90048 Recruiting
Mattel Children's Hospital UCLA Los Angeles California 90095 Recruiting
Valley Children's Hospital Madera California 93636 Recruiting
Kaiser Permanente-Oakland Oakland California 94611 Recruiting
Children's Hospital of Orange County Orange California 92868 Recruiting
Lucile Packard Children's Hospital Stanford University Palo Alto California 94304 Recruiting
Sutter Medical Center Sacramento Sacramento California 95816 Recruiting
University of California Davis Comprehensive Cancer Center Sacramento California 95817 Recruiting
Kaiser Permanente-San Diego Zion San Diego California 92120 Recruiting
Rady Children's Hospital - San Diego San Diego California 92123 Recruiting
UCSF Medical Center-Mission Bay San Francisco California 94158 Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California 90502 Active, not recruiting
Children's Hospital Colorado Aurora Colorado 80045 Recruiting
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado 80218 Recruiting
Connecticut Children's Medical Center Hartford Connecticut 06106 Recruiting
Yale University New Haven Connecticut 06520 Recruiting
Alfred I duPont Hospital for Children Wilmington Delaware 19803 Recruiting
Children's National Medical Center Washington D.C. District of Columbia 20010 Recruiting
Golisano Children's Hospital of Southwest Florida Fort Myers Florida 33908 Recruiting
University of Florida Health Science Center - Gainesville Gainesville Florida 32610 Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida 33021 Recruiting
Nemours Children's Clinic-Jacksonville Jacksonville Florida 32207 Recruiting
AdventHealth Orlando Orlando Florida 32803 Recruiting
Arnold Palmer Hospital for Children Orlando Florida 32806 Recruiting
Nemours Children's Hospital Orlando Florida 32827 Recruiting
Nemours Children's Clinic - Pensacola Pensacola Florida 32504 Recruiting
Sacred Heart Hospital Pensacola Florida 32504 Suspended
Johns Hopkins All Children's Hospital St. Petersburg Florida 33701 Recruiting
Tampa General Hospital Tampa Florida 33606 Recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida 33607 Recruiting
Saint Mary's Medical Center West Palm Beach Florida 33407 Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia 30329 Recruiting
Memorial Health University Medical Center Savannah Georgia 31404 Recruiting
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 Recruiting
Saint Luke's Cancer Institute - Boise Boise Idaho 83712 Recruiting
Lurie Children's Hospital-Chicago Chicago Illinois 60611 Recruiting
University of Illinois Chicago Illinois 60612 Recruiting
University of Chicago Comprehensive Cancer Center Chicago Illinois 60637 Recruiting
Loyola University Medical Center Maywood Illinois 60153 Recruiting
Saint Jude Midwest Affiliate Peoria Illinois 61637 Recruiting
Riley Hospital for Children Indianapolis Indiana 46202 Recruiting
Blank Children's Hospital Des Moines Iowa 50309 Recruiting
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa 52242 Recruiting
University of Kentucky/Markey Cancer Center Lexington Kentucky 40536 Recruiting
Norton Children's Hospital Louisville Kentucky 40202 Recruiting
Children's Hospital New Orleans New Orleans Louisiana 70118 Recruiting
Ochsner Medical Center Jefferson New Orleans Louisiana 70121 Active, not recruiting
Maine Children's Cancer Program Scarborough Maine 04074 Recruiting
Sinai Hospital of Baltimore Baltimore Maryland 21215 Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287 Recruiting
Walter Reed National Military Medical Center Bethesda Maryland 20889-5600 Active, not recruiting
Tufts Children's Hospital Boston Massachusetts 02111 Active, not recruiting
C S Mott Children's Hospital Ann Arbor Michigan 48109 Recruiting
Bronson Battle Creek Battle Creek Michigan 49017 Suspended
Corewell Health Dearborn Hospital Dearborn Michigan 48124 Suspended
Children's Hospital of Michigan Detroit Michigan 48201 Recruiting
Michigan State University East Lansing Michigan 48823 Active, not recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan 49503 Suspended
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan 49503 Recruiting
Trinity Health Grand Rapids Hospital Grand Rapids Michigan 49503 Suspended
Bronson Methodist Hospital Kalamazoo Michigan 49007 Suspended
West Michigan Cancer Center Kalamazoo Michigan 49007 Suspended
Beacon Kalamazoo Kalamazoo Michigan 49048 Suspended
Trinity Health Muskegon Hospital Muskegon Michigan 49444 Suspended
Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan 49120 Suspended
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan 49444 Suspended
Corewell Health Reed City Hospital Reed City Michigan 49677 Suspended
Corewell Health Children's Royal Oak Michigan 48073 Recruiting
Corewell Health William Beaumont University Hospital Royal Oak Michigan 48073 Suspended
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan 49085 Suspended
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan 49085 Suspended
Munson Medical Center Traverse City Michigan 49684 Suspended
Corewell Health Beaumont Troy Hospital Troy Michigan 48085 Suspended
University of Michigan Health - West Wyoming Michigan 49519 Suspended
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota 55404 Recruiting
University of Minnesota/Masonic Cancer Center Minneapolis Minnesota 55455 Recruiting
University of Mississippi Medical Center Jackson Mississippi 39216 Recruiting
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108 Recruiting
Cardinal Glennon Children's Medical Center St Louis Missouri 63104 Recruiting
Washington University School of Medicine St Louis Missouri 63110 Recruiting
Mercy Hospital Saint Louis St Louis Missouri 63141 Recruiting
Children's Hospital and Medical Center of Omaha Omaha Nebraska 68114 Recruiting
University of Nebraska Medical Center Omaha Nebraska 68198 Recruiting
Carson Tahoe Regional Medical Center Carson City Nevada 89703 Suspended
Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada 89052 Suspended
Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada 89052 Suspended
Las Vegas Cancer Center-Henderson Henderson Nevada 89052 Suspended
OptumCare Cancer Care at Seven Hills Henderson Nevada 89052 Suspended
Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada 89074 Suspended
OptumCare Cancer Care at Charleston Las Vegas Nevada 89102 Suspended
Hope Cancer Care of Nevada Las Vegas Nevada 89103 Suspended
Sunrise Hospital and Medical Center Las Vegas Nevada 89109 Suspended
Ann M Wierman MD LTD Las Vegas Nevada 89128 Suspended
Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada 89128 Suspended
OptumCare Cancer Care at MountainView Las Vegas Nevada 89128 Suspended
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada 89135 Recruiting
Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada 89144 Suspended
Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada 89144 Suspended
Summerlin Hospital Medical Center Las Vegas Nevada 89144 Recruiting
Las Vegas Cancer Center-Medical Center Las Vegas Nevada 89148-2405 Suspended
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89148 Suspended
OptumCare Cancer Care at Fort Apache Las Vegas Nevada 89148 Suspended
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada 89169 Suspended
Hope Cancer Care of Nevada-Pahrump Pahrump Nevada 89048 Suspended
Renown Regional Medical Center Reno Nevada 89502 Recruiting
Saint Mary's Regional Medical Center Reno Nevada 89503 Suspended
Cancer Care Specialists - Reno Reno Nevada 89511 Suspended
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire 03756 Recruiting
Hackensack University Medical Center Hackensack New Jersey 07601 Recruiting
Morristown Medical Center Morristown New Jersey 07960 Recruiting
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey 08903 Recruiting
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08903 Recruiting
Newark Beth Israel Medical Center Newark New Jersey 07112 Recruiting
Saint Joseph's Regional Medical Center Paterson New Jersey 07503 Recruiting
Albany Medical Center Albany New York 12208 Recruiting
Maimonides Medical Center Brooklyn New York 11219 Recruiting
NYU Langone Hospital - Long Island Mineola New York 11501 Recruiting
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York 11040 Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York 10016 Recruiting
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032 Recruiting
Memorial Sloan Kettering Cancer Center New York New York 10065 Recruiting
University of Rochester Rochester New York 14642 Active, not recruiting
Stony Brook University Medical Center Stony Brook New York 11794 Recruiting
State University of New York Upstate Medical University Syracuse New York 13210 Recruiting
Montefiore Medical Center - Moses Campus The Bronx New York 10467 Recruiting
UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina 27599 Recruiting
Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina 28203 Recruiting
Duke University Medical Center Durham North Carolina 27710 Recruiting
East Carolina University Greenville North Carolina 27834 Recruiting
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 Recruiting
Sanford Broadway Medical Center Fargo North Dakota 58122 Recruiting
Children's Hospital Medical Center of Akron Akron Ohio 44308 Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 Recruiting
Rainbow Babies and Childrens Hospital Cleveland Ohio 44106 Recruiting
Cleveland Clinic Foundation Cleveland Ohio 44195 Suspended
Nationwide Children's Hospital Columbus Ohio 43205 Recruiting
Dayton Children's Hospital Dayton Ohio 45404 Recruiting
ProMedica Flower Hospital Sylvania Ohio 43560 Suspended
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio 43606 Recruiting
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 Recruiting
Legacy Emanuel Children's Hospital Portland Oregon 97227 Recruiting
Oregon Health and Science University Portland Oregon 97239 Recruiting
Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania 18103 Recruiting
Geisinger Medical Center Danville Pennsylvania 17822 Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 Recruiting
Saint Christopher's Hospital for Children Philadelphia Pennsylvania 19134 Recruiting
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 Recruiting
Rhode Island Hospital Providence Rhode Island 02903 Recruiting
Prisma Health Richland Hospital Columbia South Carolina 29203 Recruiting
BI-LO Charities Children's Cancer Center Greenville South Carolina 29605 Recruiting
Prisma Health Cancer Institute - Eastside Greenville South Carolina 29615 Recruiting
Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota 57117-5134 Recruiting
East Tennessee Childrens Hospital Knoxville Tennessee 37916 Recruiting
The Children's Hospital at TriStar Centennial Nashville Tennessee 37203 Recruiting
Vanderbilt University/Ingram Cancer Center Nashville Tennessee 37232 Recruiting
Dell Children's Medical Center of Central Texas Austin Texas 78723 Recruiting
Driscoll Children's Hospital Corpus Christi Texas 78411 Recruiting
Medical City Dallas Hospital Dallas Texas 75230 Recruiting
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390 Recruiting
El Paso Children's Hospital El Paso Texas 79905 Recruiting
Cook Children's Medical Center Fort Worth Texas 76104 Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas 77030 Recruiting
M D Anderson Cancer Center Houston Texas 77030 Recruiting
Covenant Children's Hospital Lubbock Texas 79410 Recruiting
UMC Cancer Center / UMC Health System Lubbock Texas 79415 Recruiting
Children's Hospital of San Antonio San Antonio Texas 78207 Recruiting
Methodist Children's Hospital of South Texas San Antonio Texas 78229 Recruiting
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 Recruiting
Primary Children's Hospital Salt Lake City Utah 84113 Recruiting
University of Vermont and State Agricultural College Burlington Vermont 05405 Recruiting
Inova Fairfax Hospital Falls Church Virginia 22042 Recruiting
Children's Hospital of The King's Daughters Norfolk Virginia 23507 Recruiting
Overlake Medical Center Bellevue Washington 98004 Suspended
Valley Medical Center Renton Washington 98055 Suspended
Seattle Children's Hospital Seattle Washington 98105 Recruiting
Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington 99204 Recruiting
Mary Bridge Children's Hospital and Health Center Tacoma Washington 98405 Recruiting
Madigan Army Medical Center Tacoma Washington 98431 Recruiting
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington 98902 Suspended
United Hospital Center Bridgeport West Virginia 26330 Suspended
WVUH-Berkely Medical Center Martinsburg West Virginia 25401 Suspended
West Virginia University Healthcare Morgantown West Virginia 26506 Suspended
Camden Clark Medical Center Parkersburg West Virginia 26101 Suspended
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792 Active, not recruiting
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04546399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 9, 2025 · Synced May 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04546399 live on ClinicalTrials.gov.

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