ClinicalTrials.gov record
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 Apr 29, 2026, 2:20 PM 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
Conditions
Not listed
Interventions
Not listed
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
- 109
- U.S. states
- 27
- U.S. cities
- 80
| 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 |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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 Apr 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04546399 live on ClinicalTrials.gov.