Sponsor:
National Cancer Institute (NCI)
Code:
NCT06317662
Conditions
Acute Leukemia of Ambiguous Lineage
B Acute Lymphoblastic Leukemia
Eligibility Criteria
Sex: All
Age: 0 - 1
Healthy Volunteers: Not accepted
Interventions
Asparaginase Erwinia chrysanthemi
Biospecimen Collection
Blinatumomab
Bone Marrow Aspiration
Calaspargase Pegol
Brief summary:
Conditions
Acute Leukemia of Ambiguous Lineage
B Acute Lymphoblastic Leukemia
Study ID
NCT06317662
Start date
Jun 5, 2025
Status verified date
Aug, 2026
Completion date
Dec 31, 2028
Anticipated
Primary completion date
Dec 31, 2028
Anticipated
Eligibility Criteria
Sex: All
Age: 0 - 1
Healthy Volunteers: Not accepted
Enrollment
153 participants
Anticipated
Allocation
Randomized
Intervention Model
Sequential
Primary purpose
Treatment
Arms
experimental: Arm A
experimental: Arm B, Cohort 1
experimental: Arm B, Cohort 2
experimental: Arm B, Cohort 3
experimental: Arm B, Cohort 4
experimental: Arm C
experimental: Safety Phase Cohort
experimental: Steroid Prephase(prednisone, prednisolone, methylprednisolone)
Interventions
Asparaginase Erwinia chrysanthemi
Biospecimen Collection
Blinatumomab
Bone Marrow Aspiration
Calaspargase Pegol
Computed Tomography
Cyclophosphamide
Cytarabine
Daunorubicin
Dexamethasone
Doxorubicin
Echocardiography Test
FDG-Positron Emission Tomography
Leucovorin
Levoleucovorin
Lumbar Puncture
Magnetic Resonance Imaging
Mercaptopurine
Methotrexate
Methylprednisolone
Multigated Acquisition Scan
Prednisolone
Prednisone
Therapeutic Hydrocortisone
Thioguanine
Venetoclax
Vincristine
Primary outcome measure
Locations
Children's Hospital of Alabama
Recruiting
Birmingham, Alabama, United States, 35233
Contacts
Principal Investigator:
Matthew A. Kutny
Banner Children's at Desert
Recruiting
Mesa, Arizona, United States, 85202
Contacts
Site Public Contact
480-412-3100Principal Investigator:
Joseph C. Torkildson
Arkansas Children's Hospital
Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contacts
Site Public Contact
501-364-7373Principal Investigator:
Michael W. Bishop
Loma Linda University Medical Center
Recruiting
Loma Linda, California, United States, 92354
Contacts
Site Public Contact
909-558-4050Principal Investigator:
Albert Kheradpour
Miller Children's and Women's Hospital Long Beach
Recruiting
Long Beach, California, United States, 90806
Contacts
Site Public Contact
562-933-5600Principal Investigator:
Jacqueline N. Casillas
UCSF Benioff Children's Hospital Oakland
Recruiting
Oakland, California, United States, 94609
Contacts
Principal Investigator:
Anya Levinson
Kaiser Permanente-Oakland
Recruiting
Oakland, California, United States, 94611
Contacts
Principal Investigator:
Aarati V. Rao
Children's Hospital of Orange County
Recruiting
Orange, California, United States, 92868
Contacts
Principal Investigator:
Elyssa M. Rubin
University of California Davis Comprehensive Cancer Center
Recruiting
Sacramento, California, United States, 95817
Contacts
Site Public Contact
916-734-3089Principal Investigator:
Marcio H. Malogolowkin
UCSF Medical Center-Mission Bay
Recruiting
San Francisco, California, United States, 94158
Contacts
Principal Investigator:
Anya Levinson
Children's Hospital Colorado
Recruiting
Aurora, Colorado, United States, 80045
Contacts
Principal Investigator:
Kelly E. Faulk
Connecticut Children's Medical Center
Recruiting
Hartford, Connecticut, United States, 06106
Contacts
Site Public Contact
860-545-9981Principal Investigator:
Michael S. Isakoff
Yale University
Recruiting
New Haven, Connecticut, United States, 06520
Contacts
Principal Investigator:
Farzana Pashankar
Alfred I duPont Hospital for Children
Recruiting
Wilmington, Delaware, United States, 19803
Contacts
Principal Investigator:
Emi H. Caywood
Children's National Medical Center
Recruiting
Washington D.C., District of Columbia, United States, 20010
Contacts
Principal Investigator:
Jeffrey S. Dome
UF Health Cancer Institute - Gainesville
Recruiting
Gainesville, Florida, United States, 32610
Contacts
Site Public Contact
352-273-8010Principal Investigator:
Brian Stover
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Recruiting
Hollywood, Florida, United States, 33021
Contacts
Principal Investigator:
Iftikhar Hanif
Nemours Children's Clinic-Jacksonville
Recruiting
Jacksonville, Florida, United States, 32207
Contacts
Principal Investigator:
Emi H. Caywood
University of Miami Miller School of Medicine-Sylvester Cancer Center
Recruiting
Miami, Florida, United States, 33136
Contacts
Site Public Contact
305-243-2647Principal Investigator:
Julio C. Barredo
AdventHealth Orlando
Recruiting
Orlando, Florida, United States, 32803
Contacts
Principal Investigator:
Fouad M. Hajjar
Arnold Palmer Hospital for Children
Recruiting
Orlando, Florida, United States, 32806
Contacts
Principal Investigator:
Zhongbo Hu
Nemours Children's Hospital
Recruiting
Orlando, Florida, United States, 32827
Contacts
Principal Investigator:
Emi H. Caywood
Nemours Children's Clinic - Pensacola
Recruiting
Pensacola, Florida, United States, 32504
Contacts
Site Public Contact
helpdesk@childrensoncologygroup.orgPrincipal Investigator:
Jeffrey H. Schwartz
Johns Hopkins All Children's Hospital
Recruiting
St. Petersburg, Florida, United States, 33701
Contacts
Principal Investigator:
Jennifer B. Dean
Saint Joseph's Hospital/Children's Hospital-Tampa
Recruiting
Tampa, Florida, United States, 33607
Contacts
Principal Investigator:
Don E. Eslin
Saint Mary's Medical Center
Recruiting
West Palm Beach, Florida, United States, 33407
Contacts
Site Public Contact
561-822-4745Principal Investigator:
Matthew D. Ramirez
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Recruiting
Atlanta, Georgia, United States, 30329
Contacts
Principal Investigator:
Melinda G. Pauly
Kapiolani Medical Center for Women and Children
Recruiting
Honolulu, Hawaii, United States, 96826
Contacts
Site Public Contact
808-983-6090Principal Investigator:
Wade T. Kyono
Saint Luke's Cancer Institute - Boise
Recruiting
Boise, Idaho, United States, 83712
Contacts
Principal Investigator:
Martha M. Pacheco
Lurie Children's Hospital-Chicago
Recruiting
Chicago, Illinois, United States, 60611
Contacts
Site Public Contact
773-880-4562Principal Investigator:
Sara Zarnegar-Lumley
University of Chicago Comprehensive Cancer Center
Recruiting
Chicago, Illinois, United States, 60637
Contacts
Principal Investigator:
Gabrielle Lapping-Carr
Advocate Children's Hospital-Oak Lawn
Recruiting
Oak Lawn, Illinois, United States, 60453
Contacts
Site Public Contact
847-723-7570Principal Investigator:
Rebecca E. McFall
Advocate Children's Hospital-Park Ridge
Recruiting
Park Ridge, Illinois, United States, 60068
Contacts
Site Public Contact
helpdesk@childrensoncologygroup.orgPrincipal Investigator:
Rebecca E. McFall
OSF Children's Hospital of Illinois
Recruiting
Peoria, Illinois, United States, 61637
Contacts
Principal Investigator:
Prerna Kumar
Southern Illinois University School of Medicine
Recruiting
Springfield, Illinois, United States, 62702
Contacts
Site Public Contact
217-545-7929Principal Investigator:
Gregory P. Brandt
Riley Hospital for Children
Recruiting
Indianapolis, Indiana, United States, 46202
Contacts
Site Public Contact
800-248-1199Principal Investigator:
Amanda Saraf
Blank Children's Hospital
Recruiting
Des Moines, Iowa, United States, 50309
Contacts
Principal Investigator:
Samantha L. Mallory
University of Kentucky/Markey Cancer Center
Recruiting
Lexington, Kentucky, United States, 40536
Contacts
Site Public Contact
859-257-3379Principal Investigator:
James T. Badgett
Norton Children's Hospital
Recruiting
Louisville, Kentucky, United States, 40202
Contacts
Principal Investigator:
Michael J. Ferguson
Children's Hospital New Orleans
Recruiting
New Orleans, Louisiana, United States, 70118
Contacts
Site Public Contact
504-894-5377Principal Investigator:
Maria C. Velez-Yanguas
Ochsner Medical Center Jefferson
Recruiting
New Orleans, Louisiana, United States, 70121
Contacts
Principal Investigator:
Craig Lotterman
Maine Children's Cancer Program
Recruiting
Scarborough, Maine, United States, 04074
Contacts
Principal Investigator:
Sei-Gyung K. Sze
Sinai Hospital of Baltimore
Recruiting
Baltimore, Maryland, United States, 21215
Contacts
Site Public Contact
410-601-9083Principal Investigator:
Jason M. Fixler
Johns Hopkins University/Sidney Kimmel Cancer Center
Recruiting
Baltimore, Maryland, United States, 21287
Contacts
Principal Investigator:
Stacy L. Cooper
Dana-Farber Cancer Institute
Recruiting
Boston, Massachusetts, United States, 02215
Contacts
Site Public Contact
877-442-3324Principal Investigator:
Melissa A. Burns
UMass Memorial Medical Center - University Campus
Recruiting
Worcester, Massachusetts, United States, 01655
Contacts
Principal Investigator:
Stefanie R. Lowas
C S Mott Children's Hospital
Recruiting
Ann Arbor, Michigan, United States, 48109
Contacts
Site Public Contact
800-865-1125Principal Investigator:
Joshua W. Goldman
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Recruiting
Grand Rapids, Michigan, United States, 49503
Contacts
Principal Investigator:
Kathleen Y. Butler
Bronson Methodist Hospital
Recruiting
Kalamazoo, Michigan, United States, 49007
Contacts
Principal Investigator:
Kathleen Y. Butler
University of Minnesota/Masonic Cancer Center
Recruiting
Minneapolis, Minnesota, United States, 55455
Contacts
Site Public Contact
612-624-2620Principal Investigator:
Peter M. Gordon
University of Mississippi Medical Center
Recruiting
Jackson, Mississippi, United States, 39216
Contacts
Site Public Contact
601-815-6700Principal Investigator:
Amanda Strobel
Children's Mercy Hospitals and Clinics
Recruiting
Kansas City, Missouri, United States, 64108
Contacts
Principal Investigator:
Keith J. August
Washington University School of Medicine
Recruiting
St Louis, Missouri, United States, 63110
Contacts
Principal Investigator:
Laura G. Schuettpelz
Mercy Hospital Saint Louis
Recruiting
St Louis, Missouri, United States, 63141
Contacts
Site Public Contact
314-251-7066Principal Investigator:
Robin D. Hanson
Children's Hospital and Medical Center of Omaha
Recruiting
Omaha, Nebraska, United States, 68114
Contacts
Site Public Contact
402-955-3949Principal Investigator:
Jill C. Beck
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Recruiting
Las Vegas, Nevada, United States, 89135
Contacts
Principal Investigator:
Alan K. Ikeda
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Recruiting
Lebanon, New Hampshire, United States, 03756
Contacts
Principal Investigator:
Angela Ricci
Hackensack University Medical Center
Recruiting
Hackensack, New Jersey, United States, 07601
Contacts
Site Public Contact
551-996-2897Principal Investigator:
Jing Chen
Morristown Medical Center
Recruiting
Morristown, New Jersey, United States, 07960
Contacts
Site Public Contact
973-971-5900Principal Investigator:
Kathryn L. Laurie
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Recruiting
New Brunswick, New Jersey, United States, 08903
Contacts
Site Public Contact
732-235-8675Principal Investigator:
Marissa Botwinick
Saint Joseph's Regional Medical Center
Recruiting
Paterson, New Jersey, United States, 07503
Contacts
Principal Investigator:
Alissa Kahn
Albany Medical Center
Recruiting
Albany, New York, United States, 12208
Contacts
Site Public Contact
518-262-5513Principal Investigator:
Lauren R. Weintraub
Roswell Park Cancer Institute
Recruiting
Buffalo, New York, United States, 14263
Contacts
Principal Investigator:
Lisa Niswander
The Steven and Alexandra Cohen Children's Medical Center of New York
Recruiting
New Hyde Park, New York, United States, 11040
Contacts
Site Public Contact
718-470-3460Principal Investigator:
Julie I. Krystal
Memorial Sloan Kettering Cancer Center
Recruiting
New York, New York, United States, 10065
Contacts
Site Public Contact
212-639-7592Principal Investigator:
Kavitha Ramaswamy
NYP/Weill Cornell Medical Center
Recruiting
New York, New York, United States, 10065
Contacts
Site Public Contact
212-746-1848Principal Investigator:
Jaclyn Rosenzweig
University of Rochester
Recruiting
Rochester, New York, United States, 14642
Contacts
Site Public Contact
585-275-5830Principal Investigator:
Carol Fries Simpson
State University of New York Upstate Medical University
Recruiting
Syracuse, New York, United States, 13210
Contacts
Site Public Contact
315-464-5476Principal Investigator:
Melanie A. Comito
Montefiore Medical Center - Moses Campus
Recruiting
The Bronx, New York, United States, 10467
Contacts
Principal Investigator:
Alice Lee
New York Medical College
Recruiting
Valhalla, New York, United States, 10595
Contacts
Site Public Contact
914-594-3794Principal Investigator:
Andrew J. Bellantoni
UNC Lineberger Comprehensive Cancer Center
Recruiting
Chapel Hill, North Carolina, United States, 27599
Contacts
Principal Investigator:
Thomas B. Alexander
Carolinas Medical Center/Levine Cancer Institute
Recruiting
Charlotte, North Carolina, United States, 28203
Contacts
Site Public Contact
800-804-9376Principal Investigator:
Joel A. Kaplan
Duke University Medical Center
Recruiting
Durham, North Carolina, United States, 27710
Contacts
Site Public Contact
888-275-3853Principal Investigator:
Jessica M. Sun
East Carolina University
Recruiting
Greenville, North Carolina, United States, 27834
Contacts
Principal Investigator:
Andrea R. Whitfield
Wake Forest University Health Sciences
Recruiting
Winston-Salem, North Carolina, United States, 27157
Contacts
Site Public Contact
336-713-6771Principal Investigator:
Sarah Supples
Sanford Broadway Medical Center
Recruiting
Fargo, North Dakota, United States, 58122
Contacts
Principal Investigator:
Samuel J. Milanovich
Children's Hospital Medical Center of Akron
Recruiting
Akron, Ohio, United States, 44308
Contacts
Site Public Contact
330-543-3193Principal Investigator:
Erin Wright
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati, Ohio, United States, 45229
Contacts
Principal Investigator:
Erin H. Breese
Rainbow Babies and Childrens Hospital
Recruiting
Cleveland, Ohio, United States, 44106
Contacts
Site Public Contact
216-844-5437Principal Investigator:
Duncan S. Stearns
Dayton Children's Hospital
Recruiting
Dayton, Ohio, United States, 45404
Contacts
Site Public Contact
800-228-4055Principal Investigator:
Jordan M. Wright
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Recruiting
Toledo, Ohio, United States, 43606
Contacts
Principal Investigator:
Jamie L. Dargart
University of Oklahoma Health Sciences Center
Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contacts
Principal Investigator:
Rene Y. McNall-Knapp
Lehigh Valley Hospital-Cedar Crest
Recruiting
Allentown, Pennsylvania, United States, 18103
Contacts
Principal Investigator:
Jacob A. Troutman
Geisinger Medical Center
Recruiting
Danville, Pennsylvania, United States, 17822
Contacts
Principal Investigator:
Jagadeesh Ramdas
Children's Hospital of Philadelphia
Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contacts
Principal Investigator:
Kathrin M. Bernt
Children's Hospital of Pittsburgh of UPMC
Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contacts
Principal Investigator:
Jenny Ruiz
Rhode Island Hospital
Recruiting
Providence, Rhode Island, United States, 02903
Contacts
Site Public Contact
401-444-1488Principal Investigator:
Bradley DeNardo
Prisma Health Richland Hospital
Recruiting
Columbia, South Carolina, United States, 29203
Contacts
Principal Investigator:
Stuart L. Cramer
BI-LO Charities Children's Cancer Center
Recruiting
Greenville, South Carolina, United States, 29605
Contacts
Principal Investigator:
Aniket Saha
Sanford USD Medical Center - Sioux Falls
Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contacts
Principal Investigator:
Jordan Fritch-Hanson
East Tennessee Childrens Hospital
Recruiting
Knoxville, Tennessee, United States, 37916
Contacts
Site Public Contact
865-541-8266Principal Investigator:
Susan E. Spiller
Saint Jude Children's Research Hospital
Recruiting
Memphis, Tennessee, United States, 38105
Contacts
Principal Investigator:
Matthew Rees
The Children's Hospital at TriStar Centennial
Recruiting
Nashville, Tennessee, United States, 37203
Contacts
Site Public Contact
615-342-1919Principal Investigator:
Clinton M. Carroll
Vanderbilt University/Ingram Cancer Center
Recruiting
Nashville, Tennessee, United States, 37232
Contacts
Site Public Contact
800-811-8480Principal Investigator:
Brianna N. Smith
Dell Children's Medical Center of Central Texas
Recruiting
Austin, Texas, United States, 78723
Contacts
Principal Investigator:
Shannon M. Cohn
Driscoll Children's Hospital
Recruiting
Corpus Christi, Texas, United States, 78411
Contacts
Principal Investigator:
Nkechi I. Mba
Medical City Dallas Hospital
Recruiting
Dallas, Texas, United States, 75230
Contacts
Site Public Contact
972-566-5588Principal Investigator:
Maurizio L. Ghisoli
UT Southwestern/Simmons Cancer Center-Dallas
Recruiting
Dallas, Texas, United States, 75390
Contacts
Principal Investigator:
Caroline Smith
El Paso Children's Hospital
Recruiting
El Paso, Texas, United States, 79905
Contacts
Principal Investigator:
Benjamin Carcamo
Cook Children's Medical Center
Recruiting
Fort Worth, Texas, United States, 76104
Contacts
Principal Investigator:
Holly Pacenta
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Recruiting
Houston, Texas, United States, 77030
Contacts
Principal Investigator:
Joanna S. Yi
Children's Hospital of San Antonio
Recruiting
San Antonio, Texas, United States, 78207
Contacts
Principal Investigator:
Julie Voeller
Methodist Children's Hospital of South Texas
Recruiting
San Antonio, Texas, United States, 78229
Contacts
Principal Investigator:
Jose M. Esquilin
University of Virginia Cancer Center
Recruiting
Charlottesville, Virginia, United States, 22908
Contacts
Principal Investigator:
Brian C. Belyea
Children's Hospital of The King's Daughters
Recruiting
Norfolk, Virginia, United States, 23507
Contacts
Principal Investigator:
Melissa S. Mark
VCU Massey Comprehensive Cancer Center
Recruiting
Richmond, Virginia, United States, 23298
Contacts
Principal Investigator:
Jordyn R. Griffin
Carilion Children's
Recruiting
Roanoke, Virginia, United States, 24014
Contacts
Principal Investigator:
Erwood G. Edwards
Seattle Children's Hospital
Recruiting
Seattle, Washington, United States, 98105
Contacts
Site Public Contact
866-987-2000Principal Investigator:
Sarah E. Leary
Providence Sacred Heart Medical Center and Children's Hospital
Recruiting
Spokane, Washington, United States, 99204
Contacts
Principal Investigator:
Judy L. Felgenhauer
Saint Vincent Hospital Cancer Center Green Bay
Recruiting
Green Bay, Wisconsin, United States, 54301
Contacts
Principal Investigator:
Catherine A. Long
Children's Hospital of Wisconsin
Recruiting
Milwaukee, Wisconsin, United States, 53226
Contacts
Principal Investigator:
Zachary Graff
Sponsor
National Cancer Institute (NCI)
Last update posted
Sep 2, 2026
Last verified
Aug, 2026
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-02.