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Promising new combo therapy for infant leukemia shows potential

NCT ID NCT06317662

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 23 times

Summary

This study tests whether adding two targeted drugs, blinatumomab and venetoclax, to standard chemotherapy can improve outcomes for infants with a type of leukemia called acute lymphoblastic leukemia (ALL). About 153 infants will participate. The goal is to see if these combinations help more children achieve remission without cancer cells and to monitor side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 153 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 365 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321 * Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be \> 36 weeks gestational age (cumulative prenatal and postnatal age must be \> 36 weeks) at the time of enrollment * Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \[WHO\] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage * Diagnostic immunophenotype: Leukemia cells must express CD19 Exclusion Criteria: * Patients with Down Syndrome * Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy * Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of: * Steroid pretreatment: * PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility * Inhaled and topical steroids are not considered pretreatment * Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred \> 28 days before enrollment does not affect eligibility * Intrathecal cytarabine or methotrexate: * An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility * Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status * Hydroxyurea: * Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met

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Conditions

The condition(s) this trial relates to.

acute biphenotypic leukemia acute leukemia of ambiguous lineage B-cell childhood acute lymphoblastic leukemia Burkitt lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute leukemia of ambiguous lineage B acute lymphoblastic leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    115 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

  • Advocate Children's Hospital-Oak Lawn

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Advocate Children's Hospital-Park Ridge

    RECRUITING

    Park Ridge, Illinois, 60068, United States

    Contact Email: •••••@•••••

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Alfred I duPont Hospital for Children

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    RECRUITING

    Las Vegas, Nevada, 89135, United States

    Contact Email: •••••@•••••

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202-3591, United States

  • Arnold Palmer Hospital for Children

    RECRUITING

    Orlando, Florida, 32806, United States

  • BI-LO Charities Children's Cancer Center

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • Banner Children's at Desert

    RECRUITING

    Mesa, Arizona, 85202, United States

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Blank Children's Hospital

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • Bronson Methodist Hospital

    RECRUITING

    Kalamazoo, Michigan, 49007, United States

  • C S Mott Children's Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Carilion Children's

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Carolinas Medical Center/Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Medical Center of Akron

    RECRUITING

    Akron, Ohio, 44308, United States

  • Children's Hospital New Orleans

    RECRUITING

    New Orleans, Louisiana, 70118, United States

  • Children's Hospital and Medical Center of Omaha

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Children's Hospital of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Orange County

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Pittsburgh of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of San Antonio

    RECRUITING

    San Antonio, Texas, 78207, United States

  • Children's Hospital of The King's Daughters

    RECRUITING

    Norfolk, Virginia, 23507, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Children's Mercy Hospitals and Clinics

    RECRUITING

    Kansas City, Missouri, 64108, United States

    Contact Email: •••••@•••••

  • Children's National Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

    Contact Email: •••••@•••••

  • Connecticut Children's Medical Center

    SUSPENDED

    Hartford, Connecticut, 06106, United States

  • Cook Children's Medical Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

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

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Dayton Children's Hospital

    RECRUITING

    Dayton, Ohio, 45404, United States

  • Dell Children's Medical Center of Central Texas

    RECRUITING

    Austin, Texas, 78723, United States

  • Driscoll Children's Hospital

    RECRUITING

    Corpus Christi, Texas, 78411, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • East Tennessee Childrens Hospital

    RECRUITING

    Knoxville, Tennessee, 37916, United States

  • El Paso Children's Hospital

    RECRUITING

    El Paso, Texas, 79905, United States

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17822, United States

    Contact Email: •••••@•••••

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Johns Hopkins All Children's Hospital

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente-Oakland

    RECRUITING

    Oakland, California, 94611, United States

  • Kapiolani Medical Center for Women and Children

    RECRUITING

    Honolulu, Hawaii, 96826, United States

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    RECRUITING

    New York, New York, 10016, United States

    Contact Email: •••••@•••••

  • Lehigh Valley Hospital-Cedar Crest

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Loma Linda University Medical Center

    RECRUITING

    Loma Linda, California, 92354, United States

  • Lurie Children's Hospital-Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Maine Children's Cancer Program

    RECRUITING

    Scarborough, Maine, 04074, United States

    Contact Email: •••••@•••••

  • Medical City Dallas Hospital

    RECRUITING

    Dallas, Texas, 75230, United States

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Mercy Hospital Saint Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Methodist Children's Hospital of South Texas

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Miller Children's and Women's Hospital Long Beach

    RECRUITING

    Long Beach, California, 90806, United States

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • Morristown Medical Center

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • NYP/Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10065, United States

  • Nemours Children's Clinic - Pensacola

    RECRUITING

    Pensacola, Florida, 32504, United States

    Contact Email: •••••@•••••

  • Nemours Children's Clinic-Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Nemours Children's Hospital

    RECRUITING

    Orlando, Florida, 32827, United States

  • New York Medical College

    RECRUITING

    Valhalla, New York, 10595, United States

  • Norton Children's Hospital

    RECRUITING

    Louisville, Kentucky, 40202, United States

    Contact Email: •••••@•••••

  • OSF Children's Hospital of Illinois

    RECRUITING

    Peoria, Illinois, 61637, United States

    Contact Email: •••••@•••••

  • Ochsner Medical Center Jefferson

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Penn State Children's Hospital

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Prisma Health Richland Hospital

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

    Contact Email: •••••@•••••

  • Providence Alaska Medical Center

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Providence Sacred Heart Medical Center and Children's Hospital

    RECRUITING

    Spokane, Washington, 99204, United States

  • Rainbow Babies and Childrens Hospital

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    RECRUITING

    Tampa, Florida, 33607, United States

  • Saint Joseph's Regional Medical Center

    RECRUITING

    Paterson, New Jersey, 07503, United States

  • Saint Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

    Contact Email: •••••@•••••

  • Saint Luke's Cancer Institute - Boise

    RECRUITING

    Boise, Idaho, 83712, United States

  • Saint Mary's Medical Center

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Saint Vincent Hospital Cancer Center Green Bay

    RECRUITING

    Green Bay, Wisconsin, 54301, United States

  • Sanford Broadway Medical Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Sanford USD Medical Center - Sioux Falls

    RECRUITING

    Sioux Falls, South Dakota, 57117-5134, United States

    Contact Email: •••••@•••••

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Sinai Hospital of Baltimore

    RECRUITING

    Baltimore, Maryland, 21215, United States

  • Southern Illinois University School of Medicine

    RECRUITING

    Springfield, Illinois, 62702, United States

  • State University of New York Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • The Children's Hospital at TriStar Centennial

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • UCSF Benioff Children's Hospital Oakland

    RECRUITING

    Oakland, California, 94609, United States

  • UCSF Medical Center-Mission Bay

    RECRUITING

    San Francisco, California, 94158, United States

    Contact Email: •••••@•••••

  • UF Health Cancer Institute - Gainesville

    RECRUITING

    Gainesville, Florida, 32610, United States

  • UMass Memorial Medical Center - University Campus

    RECRUITING

    Worcester, Massachusetts, 01655, United States

    Contact Email: •••••@•••••

  • UNC Lineberger Comprehensive Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

    Contact Email: •••••@•••••

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • University Pediatric Hospital

    RECRUITING

    San Juan, 00926, Puerto Rico

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Kentucky/Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Minnesota/Masonic Cancer Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Virginia Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

    Contact Email: •••••@•••••

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

    Contact Email: •••••@•••••

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