Taking people in United StatesPhase 2

Testing venetoclax and blinatumomab added to chemotherapy for infants with leukemia

Tests added venetoclax or blinatumomab with chemotherapy in infants with new leukemia.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where: Akron, Albany, Allentown, Anchorage, Ann Arbor, Atlanta, Aurora, Austin, Baltimore, Birmingham, Boise, Boston, Buffalo, Chapel Hill, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Columbia, Corpus Christi, Dallas, Danville, Dayton, Des Moines, Durham, El Paso, Fargo, Fort Worth, Gainesville, Grand Rapids, Green Bay, Greenville, Hackensack, Hartford, Hershey, Hollywood, Honolulu, Houston, Indianapolis, Jackson, Jacksonville, Kalamazoo, Kansas City, Knoxville, Las Vegas, Lebanon, Lexington, Little Rock, Loma Linda, Long Beach, Louisville, Memphis, Mesa, Miami, Milwaukee, Minneapolis, Morristown, Nashville, New Brunswick, New Haven, New Hyde Park, New Orleans, New York, Norfolk, Oak Lawn, Oakland, Oklahoma City, Omaha, Orange, Orlando, Park Ridge, Paterson, Pensacola, Peoria, Philadelphia, Pittsburgh, Providence, Richmond, Roanoke, Rochester, Sacramento, San Antonio, San Francisco, Scarborough, Seattle, Sioux Falls, Spokane, Springfield, St Louis, St. Petersburg, Syracuse, Tampa, Temple, The Bronx, Toledo, Valhalla, Washington D.C., West Palm Beach, Wilmington, Winston-Salem, and Worcester, United StatesSee the 116 sites
Phase: Phase 2

Where in United States

Children's Hospital Medical Center of AkronAkron, United StatesTaking people
Albany Medical CenterAlbany, United StatesTaking people
Lehigh Valley Hospital-Cedar CrestAllentown, United StatesTaking people
Providence Alaska Medical CenterAnchorage, United StatesTaking people
C S Mott Children's HospitalAnn Arbor, United StatesTaking people
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlanta, United StatesTaking people
Children's Hospital ColoradoAurora, United StatesTaking people
Dell Children's Medical Center of Central TexasAustin, United StatesTaking people
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, United StatesTaking people
Sinai Hospital of BaltimoreBaltimore, United StatesTaking people
Children's Hospital of AlabamaBirmingham, United StatesTaking people
Saint Luke's Cancer Institute - BoiseBoise, United StatesTaking people
Dana-Farber Cancer InstituteBoston, United StatesTaking people
Roswell Park Cancer InstituteBuffalo, United StatesTaking people
UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people
Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesTaking people
University of Virginia Cancer CenterCharlottesville, United StatesTaking people
Lurie Children's Hospital-ChicagoChicago, United StatesTaking people
University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
Rainbow Babies and Childrens HospitalCleveland, United StatesTaking people
Prisma Health Richland HospitalColumbia, United StatesTaking people
Driscoll Children's HospitalCorpus Christi, United StatesTaking people
Medical City Dallas HospitalDallas, United StatesTaking people
UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesTaking people
Geisinger Medical CenterDanville, United StatesTaking people
Dayton Children's HospitalDayton, United StatesTaking people
Blank Children's HospitalDes Moines, United StatesTaking people
Duke University Medical CenterDurham, United StatesTaking people
El Paso Children's HospitalEl Paso, United StatesTaking people
Sanford Broadway Medical CenterFargo, United StatesTaking people
Cook Children's Medical CenterFort Worth, United StatesTaking people
UF Health Cancer Institute - GainesvilleGainesville, United StatesTaking people
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, United StatesTaking people
Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesTaking people
BI-LO Charities Children's Cancer CenterGreenville, United StatesTaking people
East Carolina UniversityGreenville, United StatesTaking people
Hackensack University Medical CenterHackensack, United StatesTaking people
Connecticut Children's Medical CenterHartford, United StatesTaking people
Penn State Children's HospitalHershey, United StatesTaking people
Memorial Regional Hospital/Joe DiMaggio Children's HospitalHollywood, United StatesTaking people
Kapiolani Medical Center for Women and ChildrenHonolulu, United StatesTaking people
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesTaking people
Ascension Saint Vincent Indianapolis HospitalIndianapolis, United StatesTaking people
Riley Hospital for ChildrenIndianapolis, United StatesTaking people
University of Mississippi Medical CenterJackson, United StatesTaking people
Nemours Children's Clinic-JacksonvilleJacksonville, United StatesTaking people
Bronson Methodist HospitalKalamazoo, United StatesTaking people
Children's Mercy Hospitals and ClinicsKansas City, United StatesTaking people
East Tennessee Childrens HospitalKnoxville, United StatesTaking people
Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas Vegas, United StatesTaking people
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
Arkansas Children's HospitalLittle Rock, United StatesTaking people
Loma Linda University Medical CenterLoma Linda, United StatesTaking people
Miller Children's and Women's Hospital Long BeachLong Beach, United StatesTaking people
Norton Children's HospitalLouisville, United StatesTaking people
Saint Jude Children's Research HospitalMemphis, United StatesTaking people
Banner Children's at DesertMesa, United StatesTaking people
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesTaking people
Children's Hospital of WisconsinMilwaukee, United StatesTaking people
University of Minnesota/Masonic Cancer CenterMinneapolis, United StatesTaking people
Morristown Medical CenterMorristown, United StatesTaking people
The Children's Hospital at TriStar CentennialNashville, United StatesTaking people
Vanderbilt University/Ingram Cancer CenterNashville, United StatesTaking people
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalNew Brunswick, United StatesTaking people
Yale UniversityNew Haven, United StatesTaking people
The Steven and Alexandra Cohen Children's Medical Center of New YorkNew Hyde Park, United StatesTaking people
Children's Hospital New OrleansNew Orleans, United StatesTaking people
Ochsner Medical Center JeffersonNew Orleans, United StatesTaking people
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United StatesTaking people
Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
NYP/Weill Cornell Medical CenterNew York, United StatesTaking people
Children's Hospital of The King's DaughtersNorfolk, United StatesTaking people
Advocate Children's Hospital-Oak LawnOak Lawn, United StatesTaking people
Kaiser Permanente-OaklandOakland, United StatesTaking people
UCSF Benioff Children's Hospital OaklandOakland, United StatesTaking people
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
Children's Hospital and Medical Center of OmahaOmaha, United StatesTaking people
Children's Hospital of Orange CountyOrange, United StatesTaking people
AdventHealth OrlandoOrlando, United StatesTaking people
Arnold Palmer Hospital for ChildrenOrlando, United StatesTaking people
Nemours Children's HospitalOrlando, United StatesTaking people
Advocate Children's Hospital-Park RidgePark Ridge, United StatesTaking people
Saint Joseph's Regional Medical CenterPaterson, United StatesTaking people
Nemours Children's Clinic - PensacolaPensacola, United StatesTaking people
OSF Children's Hospital of IllinoisPeoria, United StatesTaking people
Children's Hospital of PhiladelphiaPhiladelphia, United StatesTaking people
Children's Hospital of Pittsburgh of UPMCPittsburgh, United StatesTaking people
Rhode Island HospitalProvidence, United StatesTaking people
VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
Carilion Children'sRoanoke, United StatesTaking people
University of RochesterRochester, United StatesTaking people
University of California Davis Comprehensive Cancer CenterSacramento, United StatesTaking people
Children's Hospital of San AntonioSan Antonio, United StatesTaking people
Methodist Children's Hospital of South TexasSan Antonio, United StatesTaking people
UCSF Medical Center-Mission BaySan Francisco, United StatesTaking people
Maine Children's Cancer ProgramScarborough, United StatesTaking people
Seattle Children's HospitalSeattle, United StatesTaking people
Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
Providence Sacred Heart Medical Center and Children's HospitalSpokane, United StatesTaking people
Southern Illinois University School of MedicineSpringfield, United StatesTaking people
Mercy Hospital Saint LouisSt Louis, United StatesTaking people
Washington University School of MedicineSt Louis, United StatesTaking people
Johns Hopkins All Children's HospitalSt. Petersburg, United StatesTaking people
State University of New York Upstate Medical UniversitySyracuse, United StatesTaking people
Saint Joseph's Hospital/Children's Hospital-TampaTampa, United StatesTaking people
Scott and White Memorial HospitalTemple, United StatesTaking people
Montefiore Medical Center - Moses CampusThe Bronx, United StatesTaking people
ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalToledo, United StatesTaking people
New York Medical CollegeValhalla, United StatesTaking people
Children's National Medical CenterWashington D.C., United StatesTaking people
Saint Mary's Medical CenterWest Palm Beach, United StatesTaking people
Alfred I duPont Hospital for ChildrenWilmington, United StatesTaking people
Wake Forest University Health SciencesWinston-Salem, United StatesTaking people
UMass Memorial Medical Center - University CampusWorcester, United StatesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
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Trial details

Who runs it: National Cancer Institute (NCI)
Trial code: NCT06317662
Record updated: 27 October 2026
Original description: 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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Patients with Down Syndrome; Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met; All patients and/or their parents or legal guardians must sign a written informed consent.
ClinicalTrials.gov NCT06317662