NCT06317662From ClinicalTrials.govRecruiting

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

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

Acute Leukemia of Ambiguous Lineage
B Acute Lymphoblastic Leukemia

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: National Cancer Institute (NCI)
Enrolment target: 153
Started: 5 June 2025
Main results due: 31 December 2028
Study sites: 116
Registry updated: 25 September 2026

Can you take part?

Up to 365 days.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \[R\]) or without a KMT2A gene rearrangement (KMT2A-germline \[G\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs 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. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

Study sites(116)

Children's Hospital of Alabama
Birmingham, Alabama, United States
Recruiting
Providence Alaska Medical Center
Anchorage, Alaska, United States
Recruiting
Banner Children's at Desert
Mesa, Arizona, United States
Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Recruiting
Loma Linda University Medical Center
Loma Linda, California, United States
Recruiting
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States
Recruiting
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
Recruiting
Kaiser Permanente-Oakland
Oakland, California, United States
Recruiting
Children's Hospital of Orange County
Orange, California, United States
Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Recruiting
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Recruiting
Children's Hospital Colorado
Aurora, Colorado, United States
Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Suspended
Yale University
New Haven, Connecticut, United States
Recruiting
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States
Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, United States
Recruiting
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Recruiting
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States
Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Recruiting
AdventHealth Orlando
Orlando, Florida, United States
Recruiting
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Recruiting
Nemours Children's Hospital
Orlando, Florida, United States
Recruiting
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
Recruiting
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States
Recruiting
Saint Mary's Medical Center
West Palm Beach, Florida, United States
Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States
Recruiting
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Recruiting
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States
Recruiting
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Recruiting
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, United States
Recruiting
Advocate Children's Hospital-Park Ridge
Park Ridge, Illinois, United States
Recruiting
OSF Children's Hospital of Illinois
Peoria, Illinois, United States
Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Recruiting
Riley Hospital for Children
Indianapolis, Indiana, United States
Recruiting
Blank Children's Hospital
Des Moines, Iowa, United States
Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Recruiting
Norton Children's Hospital
Louisville, Kentucky, United States
Recruiting
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Recruiting
Maine Children's Cancer Program
Scarborough, Maine, United States
Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, United States
Recruiting
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Recruiting
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, United States
Recruiting
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Recruiting
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States
Recruiting
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States
Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Morristown Medical Center
Morristown, New Jersey, United States
Recruiting

Showing 60 of 116 sites — filter to narrow it down. 115 of the 116 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06317662. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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