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Study identifier: NCT06317662 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Acute Leukemia of Ambiguous Lineage · B Acute Lymphoblastic Leukemia  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 2
Planned participants153
Who can joinAll sexes, N/A to 365 Days
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Locations (113)

Children's Hospital of AlabamaBirmingham, Alabama, United StatesRecruiting
Providence Alaska Medical CenterAnchorage, Alaska, United StatesRecruiting
Banner Children's at DesertMesa, Arizona, United StatesRecruiting
Arkansas Children's HospitalLittle Rock, Arkansas, United StatesRecruiting
Loma Linda University Medical CenterLoma Linda, California, United StatesRecruiting
Miller Children's and Women's Hospital Long BeachLong Beach, California, United StatesRecruiting
UCSF Benioff Children's Hospital OaklandOakland, California, United StatesRecruiting
Kaiser Permanente-OaklandOakland, California, United StatesRecruiting
Children's Hospital of Orange CountyOrange, California, United StatesRecruiting
University of California Davis Comprehensive Cancer CenterSacramento, California, United StatesRecruiting
UCSF Medical Center-Mission BaySan Francisco, California, United StatesRecruiting
Children's Hospital ColoradoAurora, Colorado, United StatesRecruiting

+ 101 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06317662