Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek powyżej 1 roku i poniżej 25 lat
- •Nowo zdiagnozowana białaczka limfoblastyczna typu B lub mieszana ostra białaczka
- •Obecność białaczki w szpiku kostnym (ponad 25% nowotworowych komórek)
- •Dla dzieci w wieku 1-10 lat: wysoka liczba białych ciałek krwi (powyżej 50 000) lub białaczka w ośrodkowym układzie nerwowym, jądrach lub wcześniejsze leczenie sterydami
- •Dla pacjentów w wieku 10-25 lat: dowolna liczba białych ciałek krwi
- •Dla białaczki chłoniaka: zaawansowany stadium (III lub IV)
- •Zarejestrownie w wstępnym badaniu APEC14B1 (dla pacjentów z białaczką limfoblastyczną i mieszaną)
Simplified criteria — AI translation
Trial details
- Minimum age
- 365 Days
- Maximum age
- 25 Years
- Last updated (source)
- July 16, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (231)
Children's Hospital of Alabama
Birmingham, United States
USA Health Strada Patient Care Center
Mobile, United States
Providence Alaska Medical Center
Anchorage, United States
Banner Children's at Desert
Mesa, United States
Phoenix Childrens Hospital
Phoenix, United States
Banner University Medical Center - Tucson
Tucson, United States
Arkansas Children's Hospital
Little Rock, United States
Kaiser Permanente Downey Medical Center
Downey, United States
City of Hope Comprehensive Cancer Center
Duarte, United States
Loma Linda University Medical Center
Loma Linda, United States
Miller Children's and Women's Hospital Long Beach
Long Beach, United States
Children's Hospital Los Angeles
Los Angeles, United States
Cedars-Sinai Medical Center
Los Angeles, United States
Mattel Children's Hospital UCLA
Los Angeles, United States
Valley Children's Hospital
Madera, United States
UCSF Benioff Children's Hospital Oakland
Oakland, United States
Kaiser Permanente-Oakland
Oakland, United States
Children's Hospital of Orange County
Orange, United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, United States
Sutter Medical Center Sacramento
Sacramento, United States
University of California Davis Comprehensive Cancer Center
Sacramento, United States
Rady Children's Hospital - San Diego
San Diego, United States
Naval Medical Center -San Diego
San Diego, United States
UCSF Medical Center-Mission Bay
San Francisco, United States
Santa Barbara Cottage Hospital
Santa Barbara, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, United States
Children's Hospital Colorado
Aurora, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, United States
Connecticut Children's Medical Center
Hartford, United States
Yale University
New Haven, United States
Alfred I duPont Hospital for Children
Wilmington, United States
MedStar Georgetown University Hospital
Washington D.C., United States
Children's National Medical Center
Washington D.C., United States
Broward Health Medical Center
Fort Lauderdale, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, United States
UF Health Cancer Institute - Gainesville
Gainesville, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, United States
Palms West Radiation Therapy
Loxahatchee Groves, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, United States
Nicklaus Children's Hospital
Miami, United States
Miami Cancer Institute
Miami, United States
AdventHealth Orlando
Orlando, United States
Arnold Palmer Hospital for Children
Orlando, United States
Nemours Children's Hospital
Orlando, United States
Nemours Children's Clinic - Pensacola
Pensacola, United States
Sacred Heart Hospital
Pensacola, United States
Johns Hopkins All Children's Hospital
St. Petersburg, United States
Tampa General Hospital
Tampa, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, United States
Saint Mary's Medical Center
West Palm Beach, United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, United States
Augusta University Medical Center
Augusta, United States
Atrium Health Navicent
Macon, United States
Memorial Health University Medical Center
Savannah, United States
Kapiolani Medical Center for Women and Children
Honolulu, United States
Saint Luke's Cancer Institute - Boise
Boise, United States
Lurie Children's Hospital-Chicago
Chicago, United States
University of Illinois
Chicago, United States
University of Chicago Comprehensive Cancer Center
Chicago, United States
Loyola University Medical Center
Maywood, United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, United States
Advocate Children's Hospital-Park Ridge
Park Ridge, United States
OSF Children's Hospital of Illinois
Peoria, United States
Southern Illinois University School of Medicine
Springfield, United States
Northwestern Medicine Central DuPage Hospital
Winfield, United States
Riley Hospital for Children
Indianapolis, United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, United States
Blank Children's Hospital
Des Moines, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, United States
Wesley Medical Center
Wichita, United States
University of Kentucky/Markey Cancer Center
Lexington, United States
Norton Children's Hospital
Louisville, United States
Children's Hospital New Orleans
New Orleans, United States
Ochsner Medical Center Jefferson
New Orleans, United States
Eastern Maine Medical Center
Bangor, United States
Maine Children's Cancer Program
Scarborough, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, United States
Sinai Hospital of Baltimore
Baltimore, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, United States
Walter Reed National Military Medical Center
Bethesda, United States
Tufts Children's Hospital
Boston, United States
Massachusetts General Hospital Cancer Center
Boston, United States
Dana-Farber Cancer Institute
Boston, United States
Baystate Medical Center
Springfield, United States
UMass Memorial Medical Center - University Campus
Worcester, United States
C S Mott Children's Hospital
Ann Arbor, United States
Children's Hospital of Michigan
Detroit, United States
Henry Ford Health Saint John Hospital
Detroit, United States
Michigan State University
East Lansing, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, United States
Bronson Methodist Hospital
Kalamazoo, United States
Corewell Health Children's
Royal Oak, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, United States
Mayo Clinic in Rochester
Rochester, United States
University of Mississippi Medical Center
Jackson, United States
University of Missouri Children's Hospital
Columbia, United States
Children's Mercy Hospitals and Clinics
Kansas City, United States
Cardinal Glennon Children's Medical Center
St Louis, United States
Washington University School of Medicine
St Louis, United States
Mercy Hospital Saint Louis
St Louis, United States
Children's Hospital and Medical Center of Omaha
Omaha, United States
University of Nebraska Medical Center
Omaha, United States
University Medical Center of Southern Nevada
Las Vegas, United States
Sunrise Hospital and Medical Center
Las Vegas, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, United States
Summerlin Hospital Medical Center
Las Vegas, United States
Renown Regional Medical Center
Reno, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, United States
Hackensack University Medical Center
Hackensack, United States
Morristown Medical Center
Morristown, United States
Jersey Shore Medical Center
Neptune City, United States
Saint Peter's University Hospital
New Brunswick, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, United States
Newark Beth Israel Medical Center
Newark, United States
Saint Joseph's Regional Medical Center
Paterson, United States
Presbyterian Hospital
Albuquerque, United States
University of New Mexico Cancer Center
Albuquerque, United States
Albany Medical Center
Albany, United States
Maimonides Medical Center
Brooklyn, United States
Roswell Park Cancer Institute
Buffalo, United States
NYU Langone Hospital - Long Island
Mineola, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, United States
Mount Sinai Hospital
New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, United States
Memorial Sloan Kettering Cancer Center
New York, United States
NYP/Weill Cornell Medical Center
New York, United States
University of Rochester
Rochester, United States
Stony Brook University Medical Center
Stony Brook, United States
State University of New York Upstate Medical University
Syracuse, United States
Montefiore Medical Center - Moses Campus
The Bronx, United States
New York Medical College
Valhalla, United States
Mission Hospital
Asheville, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, United States
Novant Health Presbyterian Medical Center
Charlotte, United States
Duke University Medical Center
Durham, United States
East Carolina University
Greenville, United States
Wake Forest University Health Sciences
Winston-Salem, United States
Sanford Broadway Medical Center
Fargo, United States
Children's Hospital Medical Center of Akron
Akron, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
Rainbow Babies and Childrens Hospital
Cleveland, United States
Cleveland Clinic Foundation
Cleveland, United States
Nationwide Children's Hospital
Columbus, United States
Dayton Children's Hospital
Dayton, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, United States
University of Oklahoma Health Sciences Center
Oklahoma City, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, United States
Legacy Emanuel Children's Hospital
Portland, United States
Oregon Health and Science University
Portland, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, United States
Geisinger Medical Center
Danville, United States
Penn State Children's Hospital
Hershey, United States
Children's Hospital of Philadelphia
Philadelphia, United States
Saint Christopher's Hospital for Children
Philadelphia, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, United States
Rhode Island Hospital
Providence, United States
Medical University of South Carolina
Charleston, United States
Prisma Health Richland Hospital
Columbia, United States
BI-LO Charities Children's Cancer Center
Greenville, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, United States
T C Thompson Children's Hospital
Chattanooga, United States
East Tennessee Childrens Hospital
Knoxville, United States
The Children's Hospital at TriStar Centennial
Nashville, United States
Vanderbilt University/Ingram Cancer Center
Nashville, United States
Texas Tech University Health Sciences Center-Amarillo
Amarillo, United States
Dell Children's Medical Center of Central Texas
Austin, United States
Driscoll Children's Hospital
Corpus Christi, United States
Medical City Dallas Hospital
Dallas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, United States
El Paso Children's Hospital
El Paso, United States
Cook Children's Medical Center
Fort Worth, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, United States
UT MD Anderson Cancer Center
Houston, United States
Covenant Children's Hospital
Lubbock, United States
UMC Cancer Center / UMC Health System
Lubbock, United States
Vannie Cook Children's Clinic
McAllen, United States
Children's Hospital of San Antonio
San Antonio, United States
Methodist Children's Hospital of South Texas
San Antonio, United States
University of Texas Health Science Center at San Antonio
San Antonio, United States
Scott and White Memorial Hospital
Temple, United States
Primary Children's Hospital
Salt Lake City, United States
University of Vermont and State Agricultural College
Burlington, United States
University of Virginia Cancer Center
Charlottesville, United States
Inova Fairfax Hospital
Falls Church, United States
Children's Hospital of The King's Daughters
Norfolk, United States
Naval Medical Center - Portsmouth
Portsmouth, United States
VCU Massey Comprehensive Cancer Center
Richmond, United States
Carilion Children's
Roanoke, United States
Seattle Children's Hospital
Seattle, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, United States
Madigan Army Medical Center
Tacoma, United States
West Virginia University Charleston Division
Charleston, United States
Edwards Comprehensive Cancer Center
Huntington, United States
West Virginia University Healthcare
Morgantown, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, United States
Marshfield Medical Center-Marshfield
Marshfield, United States
Children's Hospital of Wisconsin
Milwaukee, United States
John Hunter Children's Hospital
Hunter Regional Mail Centre, Australia
The Children's Hospital at Westmead
Westmead, Australia
Queensland Children's Hospital
South Brisbane, Australia
Women's and Children's Hospital-Adelaide
North Adelaide, Australia
Royal Hobart Hospital
Saint Hobart, Australia
Monash Medical Center-Clayton Campus
Clayton, Australia
Royal Children's Hospital
Parkville, Australia
Perth Children's Hospital
Perth, Australia
Alberta Children's Hospital
Calgary, Canada
University of Alberta Hospital
Edmonton, Canada
British Columbia Children's Hospital
Vancouver, Canada
CancerCare Manitoba
Winnipeg, Canada
Janeway Child Health Centre
St. John's, Canada
IWK Health Centre
Halifax, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Canada
Kingston Health Sciences Centre
Kingston, Canada
Children's Hospital
London, Canada
Children's Hospital of Eastern Ontario
Ottawa, Canada
Hospital for Sick Children
Toronto, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Canada
Jim Pattison Children's Hospital
Saskatoon, Canada
Saskatoon Cancer Centre
Saskatoon, Canada
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec, Canada
Starship Children's Hospital
Grafton, New Zealand
Christchurch Hospital
Christchurch, New Zealand
HIMA San Pablo Oncologic Hospital
Caguas, Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico
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Matthew A. Kutny
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