Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia

ClinicalTrials.gov ID: NCT06317662

Public ClinicalTrials.gov record NCT06317662. 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.

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ClinicalTrials.gov public records Last synced May 9, 2026, 9:32 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 in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

Study identification

NCT ID: NCT06317662
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: National Cancer Institute (NCI); NIH
Enrollment: 153 participants

Conditions and interventions

Conditions

Interventions

Asparaginase Erwinia chrysanthemi Drug
Biospecimen Collection Procedure
Blinatumomab Biological
Bone Marrow Aspiration Procedure
Calaspargase Pegol Drug
Computed Tomography Procedure
Cyclophosphamide Drug
Cytarabine Drug
Daunorubicin Drug
Dexamethasone Drug
Doxorubicin Drug
Echocardiography Test Procedure
FDG-Positron Emission Tomography Procedure
Leucovorin Drug
Levoleucovorin Drug
Lumbar Puncture Procedure
Magnetic Resonance Imaging Procedure
Mercaptopurine Drug
Methotrexate Drug
Methylprednisolone Drug
Multigated Acquisition Scan Procedure
Prednisolone Drug
Prednisone Drug
Therapeutic Hydrocortisone Drug
Thioguanine Drug
Venetoclax Drug
Vincristine Drug

Drug · Procedure · Biological

Eligibility (public fields only)

Age range: Up to 365 Days
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: Jun 4, 2025
Primary completion: Dec 30, 2028
Completion: Dec 30, 2028
Last update posted: May 6, 2026

2025 – 2028

United States locations

U.S. sites: 107
U.S. states: 40
U.S. cities: 96

Facility	City	State	ZIP	Site status
Children's Hospital of Alabama	Birmingham	Alabama	35233	Recruiting
Providence Alaska Medical Center	Anchorage	Alaska	99508	Recruiting
Banner Children's at Desert	Mesa	Arizona	85202	Recruiting
Arkansas Children's Hospital	Little Rock	Arkansas	72202-3591	Recruiting
Loma Linda University Medical Center	Loma Linda	California	92354	Recruiting
Miller Children's and Women's Hospital Long Beach	Long Beach	California	90806	Recruiting
UCSF Benioff Children's Hospital Oakland	Oakland	California	94609	Recruiting
Kaiser Permanente-Oakland	Oakland	California	94611	Recruiting
Children's Hospital of Orange County	Orange	California	92868	Recruiting
University of California Davis Comprehensive Cancer Center	Sacramento	California	95817	Recruiting
UCSF Medical Center-Mission Bay	San Francisco	California	94158	Recruiting
Children's Hospital Colorado	Aurora	Colorado	80045	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
UF Health Cancer Institute - 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
University of Miami Miller School of Medicine-Sylvester Cancer Center	Miami	Florida	33136	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
Johns Hopkins All Children's Hospital	St. Petersburg	Florida	33701	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
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
Advocate Children's Hospital-Oak Lawn	Oak Lawn	Illinois	60453	Recruiting
Advocate Children's Hospital-Park Ridge	Park Ridge	Illinois	60068	Recruiting
Southern Illinois University School of Medicine	Springfield	Illinois	62702	Recruiting
Riley Hospital for Children	Indianapolis	Indiana	46202	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	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
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
UMass Memorial Medical Center - University Campus	Worcester	Massachusetts	01655	Recruiting
C S Mott Children's Hospital	Ann Arbor	Michigan	48109	Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital	Grand Rapids	Michigan	49503	Recruiting
Bronson Methodist Hospital	Kalamazoo	Michigan	49007	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
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
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center	Lebanon	New Hampshire	03756	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
Morristown Medical Center	Morristown	New Jersey	07960	Recruiting
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital	New Brunswick	New Jersey	08903	Recruiting
Saint Joseph's Regional Medical Center	Paterson	New Jersey	07503	Recruiting
Albany Medical Center	Albany	New York	12208	Recruiting
Roswell Park Cancer Institute	Buffalo	New York	14263	Recruiting
The Steven and Alexandra Cohen Children's Medical Center of New York	New Hyde Park	New York	11040	Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York	10016	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Recruiting
NYP/Weill Cornell Medical Center	New York	New York	10065	Recruiting
University of Rochester	Rochester	New York	14642	Recruiting
State University of New York Upstate Medical University	Syracuse	New York	13210	Recruiting
Montefiore Medical Center - Moses Campus	The Bronx	New York	10467	Recruiting
New York Medical College	Valhalla	New York	10595	Recruiting
Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina	28203	Recruiting
Duke University Medical Center	Durham	North Carolina	27710	Recruiting
East Carolina University	Greenville	North Carolina	27834	Recruiting
Wake Forest University Health Sciences	Winston-Salem	North Carolina	27157	Recruiting
Children's Hospital Medical Center of Akron	Akron	Ohio	44308	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Rainbow Babies and Childrens Hospital	Cleveland	Ohio	44106	Recruiting
Dayton Children's Hospital	Dayton	Ohio	45404	Recruiting
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital	Toledo	Ohio	43606	Recruiting
University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	73104	Recruiting
Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	18103	Recruiting
Geisinger Medical Center	Danville	Pennsylvania	17822	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	15224	Recruiting
Rhode Island Hospital	Providence	Rhode Island	02903	Recruiting
Prisma Health Richland Hospital	Columbia	South Carolina	29203	Recruiting
BI-LO Charities Children's Cancer Center	Greenville	South Carolina	29605	Recruiting
Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	57117-5134	Recruiting
East Tennessee Childrens Hospital	Knoxville	Tennessee	37916	Recruiting
Saint Jude Children's Research Hospital	Memphis	Tennessee	38105	Recruiting
The Children's Hospital at TriStar Centennial	Nashville	Tennessee	37203	Recruiting
Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee	37232	Recruiting
Dell Children's Medical Center of Central Texas	Austin	Texas	78723	Recruiting
Driscoll Children's Hospital	Corpus Christi	Texas	78411	Recruiting
Medical City Dallas Hospital	Dallas	Texas	75230	Recruiting
UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas	75390	Recruiting
El Paso Children's Hospital	El Paso	Texas	79905	Recruiting
Cook Children's Medical Center	Fort Worth	Texas	76104	Recruiting
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas	77030	Recruiting
Children's Hospital of San Antonio	San Antonio	Texas	78207	Recruiting
Methodist Children's Hospital of South Texas	San Antonio	Texas	78229	Recruiting
University of Virginia Cancer Center	Charlottesville	Virginia	22908	Recruiting
Children's Hospital of The King's Daughters	Norfolk	Virginia	23507	Recruiting
VCU Massey Comprehensive Cancer Center	Richmond	Virginia	23298	Recruiting
Carilion Children's	Roanoke	Virginia	24014	Recruiting
Seattle Children's Hospital	Seattle	Washington	98105	Recruiting
Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington	99204	Recruiting
Saint Vincent Hospital Cancer Center Green Bay	Green Bay	Wisconsin	54301	Recruiting
Children's Hospital of Wisconsin	Milwaukee	Wisconsin	53226	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06317662, 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 May 6, 2026 · Synced May 9, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06317662 live on ClinicalTrials.gov.

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