A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT04546399
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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.
Interventions
-
3-Dimensional Conformal Radiation Therapy
(Radiation)
Undergo 3D-CRT
-
Asparaginase Erwinia chrysanthemi
(Drug)
Given IM
-
Biospecimen Collection
(Procedure)
Undergo blood, urine and cerebrospinal fluid collection
-
Blinatumomab
(Biological)
Given IV
-
Bone Marrow Aspiration
(Procedure)
Undergo bone marrow aspiration
-
Bone Marrow Biopsy
(Procedure)
Undergo bone marrow biopsy
-
Calaspargase Pegol
(Drug)
Given IV
-
Cytarabine
(Drug)
Given IT
-
Dexamethasone
(Drug)
Given PO or IV
-
Hydrocortisone Sodium Succinate
(Drug)
Given IT
-
Lumbar Puncture
(Procedure)
Undergo lumbar puncture
-
Mercaptopurine
(Drug)
Given PO
-
Methotrexate
(Drug)
Given IT, PO, and IV
-
Nivolumab
(Biological)
Given IV
-
Pegaspargase
(Drug)
Given IM or IV
-
Vincristine Sulfate
(Drug)
Given IV push or via infusion
Eligibility criteria
Conditions
Locations
- Children's Hospital of Alabama — Birmingham, Alabama, United States
- USA Health Strada Patient Care Center — Mobile, Alabama, United States
- Providence Alaska Medical Center — Anchorage, Alaska, United States
- Kingman Regional Medical Center — Kingman, Arizona, United States
- Banner Children's at Desert — Mesa, Arizona, United States
- Phoenix Childrens Hospital — Phoenix, Arizona, United States
- Banner University Medical Center - Tucson — Tucson, Arizona, United States
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- Kaiser Permanente-Anaheim — Anaheim, California, United States
- PCR Oncology — Arroyo Grande, California, United States
- Kaiser Permanente-Bellflower — Bellflower, California, United States
- Kaiser Permanente Downey Medical Center — Downey, California, United States
- City of Hope Comprehensive Cancer Center — Duarte, California, United States
- Kaiser Permanente-Fontana — Fontana, California, United States
- Loma Linda University Medical Center — Loma Linda, California, United States
- Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Mattel Children's Hospital UCLA — Los Angeles, California, United States
- Valley Children's Hospital — Madera, California, United States
- Kaiser Permanente-Oakland — Oakland, California, United States
- Children's Hospital of Orange County — Orange, California, United States
- Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
- Sutter Medical Center Sacramento — Sacramento, California, United States
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
- Kaiser Permanente-San Diego Zion — San Diego, California, United States
- Rady Children's Hospital - San Diego — San Diego, California, United States
- UCSF Medical Center-Mission Bay — San Francisco, California, United States
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
- Connecticut Children's Medical Center — Hartford, Connecticut, United States
- Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
- UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
- Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
- AdventHealth Orlando — Orlando, Florida, United States
- Arnold Palmer Hospital for Children — Orlando, Florida, United States
- Nemours Children's Hospital — Orlando, Florida, United States
- Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
- Sacred Heart Hospital — Pensacola, Florida, United States
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
- Saint Mary's Medical Center — West Palm Beach, Florida, United States
- Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States
- Memorial Health University Medical Center — Savannah, Georgia, United States
- Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
- Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
- Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
- University of Illinois — Chicago, Illinois, United States
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- OSF Children's Hospital of Illinois — Peoria, Illinois, United States
- Riley Hospital for Children — Indianapolis, Indiana, United States
- Blank Children's Hospital — Des Moines, Iowa, United States
- University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
- Norton Children's Hospital — Louisville, Kentucky, United States
- Children's Hospital New Orleans — New Orleans, Louisiana, United States
- Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States
- Eastern Maine Medical Center — Bangor, Maine, United States
- Maine Children's Cancer Program — Scarborough, Maine, United States
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States
- Tufts Children's Hospital — Boston, Massachusetts, United States
- C S Mott Children's Hospital — Ann Arbor, Michigan, United States
- Bronson Battle Creek — Battle Creek, Michigan, United States
- Corewell Health Dearborn Hospital — Dearborn, Michigan, United States
- Children's Hospital of Michigan — Detroit, Michigan, United States
- Michigan State University — East Lansing, Michigan, United States
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital — Grand Rapids, Michigan, United States
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
- Trinity Health Grand Rapids Hospital — Grand Rapids, Michigan, United States
- Bronson Methodist Hospital — Kalamazoo, Michigan, United States
- West Michigan Cancer Center — Kalamazoo, Michigan, United States
- Beacon Kalamazoo — Kalamazoo, Michigan, United States
- Trinity Health Muskegon Hospital — Muskegon, Michigan, United States
- Corewell Health Lakeland Hospitals - Niles Hospital — Niles, Michigan, United States
- Cancer and Hematology Centers of Western Michigan - Norton Shores — Norton Shores, Michigan, United States
- Corewell Health Reed City Hospital — Reed City, Michigan, United States
- Corewell Health Children's — Royal Oak, Michigan, United States
- Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center — Saint Joseph, Michigan, United States
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital — Saint Joseph, Michigan, United States
- Munson Medical Center — Traverse City, Michigan, United States
- Corewell Health Beaumont Troy Hospital — Troy, Michigan, United States
- University of Michigan Health - West — Wyoming, Michigan, United States
- Children's Hospitals and Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States
- University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
- University of Mississippi Medical Center — Jackson, Mississippi, United States
- Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
- Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Mercy Hospital Saint Louis — St Louis, Missouri, United States
- Children's Hospital and Medical Center of Omaha — Omaha, Nebraska, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Carson Tahoe Regional Medical Center — Carson City, Nevada, United States
- Comprehensive Cancer Centers of Nevada - Henderson — Henderson, Nevada, United States
- Comprehensive Cancer Centers of Nevada-Horizon Ridge — Henderson, Nevada, United States
- Las Vegas Cancer Center-Henderson — Henderson, Nevada, United States
- Comprehensive Cancer Centers of Nevada-Southeast Henderson — Henderson, Nevada, United States
- OptumCare Cancer Care at Charleston — Las Vegas, Nevada, United States
- Hope Cancer Care of Nevada — Las Vegas, Nevada, United States
- Sunrise Hospital and Medical Center — Las Vegas, Nevada, United States
- Ann M Wierman MD LTD — Las Vegas, Nevada, United States
- Comprehensive Cancer Centers of Nevada - Northwest — Las Vegas, Nevada, United States
- OptumCare Cancer Care at MountainView — Las Vegas, Nevada, United States
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation — Las Vegas, Nevada, United States
- Comprehensive Cancer Centers of Nevada - Town Center — Las Vegas, Nevada, United States
- Comprehensive Cancer Centers of Nevada-Summerlin — Las Vegas, Nevada, United States
- Summerlin Hospital Medical Center — Las Vegas, Nevada, United States
- Las Vegas Cancer Center-Medical Center — Las Vegas, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Comprehensive Cancer Centers of Nevada - Central Valley — Las Vegas, Nevada, United States
- OptumCare Cancer Care at Fort Apache — Las Vegas, Nevada, United States
- Hope Cancer Care of Nevada-Pahrump — Pahrump, Nevada, United States
- Renown Regional Medical Center — Reno, Nevada, United States
- Saint Mary's Regional Medical Center — Reno, Nevada, United States
- Cancer Care Specialists - Reno — Reno, Nevada, United States
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center — Lebanon, New Hampshire, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Morristown Medical Center — Morristown, New Jersey, United States
- Saint Peter's University Hospital — New Brunswick, New Jersey, United States
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Newark Beth Israel Medical Center — Newark, New Jersey, United States
- Saint Joseph's Regional Medical Center — Paterson, New Jersey, United States
- Presbyterian Hospital — Albuquerque, New Mexico, United States
- Albany Medical Center — Albany, New York, United States
- Maimonides Medical Center — Brooklyn, New York, United States
- NYU Langone Hospital - Long Island — Mineola, New York, United States
- The Steven and Alexandra Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- NYP/Weill Cornell Medical Center — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Stony Brook University Medical Center — Stony Brook, New York, United States
- State University of New York Upstate Medical University — Syracuse, New York, United States
- Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
- Mission Hospital — Asheville, North Carolina, United States
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
- Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- East Carolina University — Greenville, North Carolina, United States
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
- Sanford Broadway Medical Center — Fargo, North Dakota, United States
- Children's Hospital Medical Center of Akron — Akron, Ohio, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Dayton Children's Hospital — Dayton, Ohio, United States
- ProMedica Flower Hospital — Sylvania, Ohio, United States
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital — Toledo, Ohio, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- Saint Francis Children's Hospital — Tulsa, Oklahoma, United States
- Legacy Emanuel Children's Hospital — Portland, Oregon, United States
- Oregon Health and Science University — Portland, Oregon, United States
- Lehigh Valley Hospital-Cedar Crest — Allentown, Pennsylvania, United States
- Geisinger Medical Center — Danville, Pennsylvania, United States
- Penn State Children's Hospital — Hershey, Pennsylvania, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Saint Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- Prisma Health Richland Hospital — Columbia, South Carolina, United States
- BI-LO Charities Children's Cancer Center — Greenville, South Carolina, United States
- Prisma Health Cancer Institute - Eastside — Greenville, South Carolina, United States
- Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
- East Tennessee Childrens Hospital — Knoxville, Tennessee, United States
- The Children's Hospital at TriStar Centennial — Nashville, Tennessee, United States
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
- Dell Children's Medical Center of Central Texas — Austin, Texas, United States
- Driscoll Children's Hospital — Corpus Christi, Texas, United States
- Medical City Dallas Hospital — Dallas, Texas, United States
- UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
- El Paso Children's Hospital — El Paso, Texas, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
- UT MD Anderson Cancer Center — Houston, Texas, United States
- Covenant Children's Hospital — Lubbock, Texas, United States
- UMC Cancer Center / UMC Health System — Lubbock, Texas, United States
- Children's Hospital of San Antonio — San Antonio, Texas, United States
- Methodist Children's Hospital of South Texas — San Antonio, Texas, United States
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
- Primary Children's Hospital — Salt Lake City, Utah, United States
- University of Vermont and State Agricultural College — Burlington, Vermont, United States
- Inova Fairfax Hospital — Falls Church, Virginia, United States
- Children's Hospital of The King's Daughters — Norfolk, Virginia, United States
- VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
- Overlake Medical Center — Bellevue, Washington, United States
- Valley Medical Center — Renton, Washington, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- Providence Sacred Heart Medical Center and Children's Hospital — Spokane, Washington, United States
- Mary Bridge Children's Hospital and Health Center — Tacoma, Washington, United States
- Madigan Army Medical Center — Tacoma, Washington, United States
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital — Yakima, Washington, United States
- United Hospital Center — Bridgeport, West Virginia, United States
- West Virginia University Charleston Division — Charleston, West Virginia, United States
- WVUH-Berkely Medical Center — Martinsburg, West Virginia, United States
- West Virginia University Healthcare — Morgantown, West Virginia, United States
- Camden Clark Medical Center — Parkersburg, West Virginia, United States
- Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
- University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
- John Hunter Children's Hospital — Hunter Regional Mail Centre, New South Wales, Australia
- Sydney Children's Hospital — Randwick, New South Wales, Australia
- The Children's Hospital at Westmead — Westmead, New South Wales, Australia
- Queensland Children's Hospital — South Brisbane, Queensland, Australia
- Perth Children's Hospital — Perth, Western Australia, Australia
- Alberta Children's Hospital — Calgary, Alberta, Canada
- University of Alberta Hospital — Edmonton, Alberta, Canada
- British Columbia Children's Hospital — Vancouver, British Columbia, Canada
- CancerCare Manitoba — Winnipeg, Manitoba, Canada
- Janeway Child Health Centre — St. John's, Newfoundland and Labrador, Canada
- IWK Health Centre — Halifax, Nova Scotia, Canada
- The Montreal Children's Hospital of the MUHC — Montreal, Quebec, Canada
- Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont — Sherbrooke, Quebec, Canada
- CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) — Québec, Canada
- University Pediatric Hospital — San Juan, Puerto Rico
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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