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ACTIVE NOT RECRUITING
NCT02101853
PHASE3

Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.

Official title: Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Key Details

Gender

All

Age Range

1 Year - 31 Years

Study Type

INTERVENTIONAL

Enrollment

669

Start Date

2014-12-17

Completion Date

2026-09-16

Last Updated

2025-12-01

Healthy Volunteers

No

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic HSCT

DRUG

Asparaginase

Given IM or IV

BIOLOGICAL

Blinatumomab

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT and IV or SC

DRUG

Dexamethasone

Given PO or IV

DRUG

Etoposide

Given IV

DRUG

Leucovorin Calcium

Given IV or PO

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, IV, and PO

DRUG

Mitoxantrone

Given IV

DRUG

Mitoxantrone Hydrochloride

Given IV

DRUG

Pegaspargase

Given IV

OTHER

Pharmacological Study

Correlative studies

RADIATION

Radiation Therapy

Undergo cranial radiation therapy

DRUG

Therapeutic Hydrocortisone

Given IT

DRUG

Thioguanine

Given PO

DRUG

Vincristine

Given IV

DRUG

Vincristine Sulfate

Given IV

Locations (186)

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

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 Downey Medical Center

Downey, California, United States

City of Hope Comprehensive Cancer Center

Duarte, 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

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

UCSF Benioff Children's Hospital Oakland

Oakland, 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

Rady Children's Hospital - San Diego

San Diego, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Santa Barbara Cottage Hospital

Santa Barbara, 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

Yale University

New Haven, 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

Broward Health Medical Center

Fort Lauderdale, Florida, 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

Palms West Radiation Therapy

Loxahatchee Groves, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Nemours Children's Clinic - Pensacola

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

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, United States

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, United States

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Norton Children's Hospital

Louisville, Kentucky, 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

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 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

Baystate Medical Center

Springfield, Massachusetts, United States

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Michigan State University

East Lansing, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

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

Grand Rapids, Michigan, United States

Corewell Health Children's

Royal Oak, 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

Mayo Clinic in Rochester

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Children's Mercy Hospitals and Clinics

Kansas City, 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

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States

Summerlin Hospital Medical Center

Las Vegas, 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

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Saint Joseph's Regional Medical Center

Paterson, New Jersey, United States

Albany Medical Center

Albany, New York, United States

Roswell Park Cancer Institute

Buffalo, 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

Mount Sinai Hospital

New York, New York, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive 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

New York Medical College

Valhalla, 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

Novant Health Presbyterian Medical Center

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

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 Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, 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

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Geisinger Medical Center

Danville, 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

Medical University of South Carolina

Charleston, South Carolina, United States

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

T C Thompson Children's Hospital

Chattanooga, Tennessee, 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

Covenant Children's Hospital

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

Scott and White Memorial Hospital

Temple, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

University of Virginia Cancer Center

Charlottesville, Virginia, 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

Carilion Children's

Roanoke, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

Madigan Army Medical Center

Tacoma, Washington, United States

West Virginia University Charleston Division

Charleston, West Virginia, United States

West Virginia University Healthcare

Morgantown, West Virginia, United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Perth Children's Hospital

Perth, Western Australia, Australia

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

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Children's Hospital

London, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Hospital for Sick Children

Toronto, Ontario, Canada

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

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

Québec, Canada

Starship Children's Hospital

Grafton, Auckland, New Zealand

Christchurch Hospital

Christchurch, New Zealand

HIMA San Pablo Oncologic Hospital

Caguas, Puerto Rico

San Jorge Children's Hospital

San Juan, Puerto Rico

University Pediatric Hospital

San Juan, Puerto Rico