{
  "data": {
    "asOf": "2026-10-30T22:26:36.214Z",
    "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only",
    "byRegistry": {
      "clinicaltrials_gov": 1
    },
    "canonicalTrial": {
      "canonicalId": "NCT06317662",
      "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",
      "scientificTitle": "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",
      "status": "recruiting",
      "studyType": "interventional",
      "phase": [
        "PHASE2"
      ],
      "conditions": [
        "Acute Leukemia of Ambiguous Lineage",
        "B Acute Lymphoblastic Leukemia"
      ],
      "interventions": [
        {
          "name": "Asparaginase Erwinia chrysanthemi",
          "type": "DRUG",
          "description": "Given recombinant crisantaspase IM or crisantaspase IM or IV"
        },
        {
          "name": "Biospecimen Collection",
          "type": "PROCEDURE",
          "description": "Undergo collection of blood samples"
        },
        {
          "name": "Blinatumomab",
          "type": "BIOLOGICAL",
          "description": "Given IV"
        },
        {
          "name": "Bone Marrow Aspiration",
          "type": "PROCEDURE",
          "description": "Undergo bone marrow aspiration"
        },
        {
          "name": "Calaspargase Pegol",
          "type": "DRUG",
          "description": "Given IV"
        },
        {
          "name": "Computed Tomography",
          "type": "PROCEDURE",
          "description": "Undergo CT"
        },
        {
          "name": "Cyclophosphamide",
          "type": "DRUG",
          "description": "Given IV"
        },
        {
          "name": "Cytarabine",
          "type": "DRUG",
          "description": "Given IT or IV"
        },
        {
          "name": "Daunorubicin",
          "type": "DRUG",
          "description": "Given IV"
        },
        {
          "name": "Dexamethasone",
          "type": "DRUG",
          "description": "Given PO or NG or IV"
        },
        {
          "name": "Doxorubicin",
          "type": "DRUG",
          "description": "Given IV"
        },
        {
          "name": "Echocardiography Test",
          "type": "PROCEDURE",
          "description": "Undergo ECHO"
        },
        {
          "name": "FDG-Positron Emission Tomography",
          "type": "PROCEDURE",
          "description": "Undergo FDG-PET"
        },
        {
          "name": "Leucovorin",
          "type": "DRUG",
          "description": "Given PO or NG or IV"
        },
        {
          "name": "Levoleucovorin",
          "type": "DRUG",
          "description": "Given IV"
        },
        {
          "name": "Lumbar Puncture",
          "type": "PROCEDURE",
          "description": "Undergo lumbar puncture"
        },
        {
          "name": "Magnetic Resonance Imaging",
          "type": "PROCEDURE",
          "description": "Undergo MRI"
        },
        {
          "name": "Mercaptopurine",
          "type": "DRUG",
          "description": "Given PO or NG"
        },
        {
          "name": "Methotrexate",
          "type": "DRUG",
          "description": "Given IT or IV or PO or NG"
        },
        {
          "name": "Methylprednisolone",
          "type": "DRUG",
          "description": "Given IV"
        },
        {
          "name": "Multigated Acquisition Scan",
          "type": "PROCEDURE",
          "description": "Undergo MUGA"
        },
        {
          "name": "Prednisolone",
          "type": "DRUG",
          "description": "Given PO or NG"
        },
        {
          "name": "Prednisone",
          "type": "DRUG",
          "description": "Given PO or NG"
        },
        {
          "name": "Therapeutic Hydrocortisone",
          "type": "DRUG",
          "description": "Given IT"
        },
        {
          "name": "Thioguanine",
          "type": "DRUG",
          "description": "Given PO or NG"
        },
        {
          "name": "Venetoclax",
          "type": "DRUG",
          "description": "Given PO or NG"
        },
        {
          "name": "Vincristine",
          "type": "DRUG",
          "description": "Given IV"
        }
      ],
      "sponsor": {
        "name": "National Cancer Institute (NCI)",
        "type": "NIH"
      },
      "locations": [
        {
          "city": "Birmingham",
          "country": "United States",
          "facility": "Children's Hospital of Alabama"
        },
        {
          "city": "Anchorage",
          "country": "United States",
          "facility": "Providence Alaska Medical Center"
        },
        {
          "city": "Mesa",
          "country": "United States",
          "facility": "Banner Children's at Desert"
        },
        {
          "city": "Little Rock",
          "country": "United States",
          "facility": "Arkansas Children's Hospital"
        },
        {
          "city": "Loma Linda",
          "country": "United States",
          "facility": "Loma Linda University Medical Center"
        },
        {
          "city": "Long Beach",
          "country": "United States",
          "facility": "Miller Children's and Women's Hospital Long Beach"
        },
        {
          "city": "Oakland",
          "country": "United States",
          "facility": "UCSF Benioff Children's Hospital Oakland"
        },
        {
          "city": "Oakland",
          "country": "United States",
          "facility": "Kaiser Permanente-Oakland"
        },
        {
          "city": "Orange",
          "country": "United States",
          "facility": "Children's Hospital of Orange County"
        },
        {
          "city": "Sacramento",
          "country": "United States",
          "facility": "University of California Davis Comprehensive Cancer Center"
        },
        {
          "city": "San Francisco",
          "country": "United States",
          "facility": "UCSF Medical Center-Mission Bay"
        },
        {
          "city": "Aurora",
          "country": "United States",
          "facility": "Children's Hospital Colorado"
        },
        {
          "city": "Hartford",
          "country": "United States",
          "facility": "Connecticut Children's Medical Center"
        },
        {
          "city": "New Haven",
          "country": "United States",
          "facility": "Yale University"
        },
        {
          "city": "Wilmington",
          "country": "United States",
          "facility": "Alfred I duPont Hospital for Children"
        },
        {
          "city": "Washington D.C.",
          "country": "United States",
          "facility": "Children's National Medical Center"
        },
        {
          "city": "Gainesville",
          "country": "United States",
          "facility": "UF Health Cancer Institute - Gainesville"
        },
        {
          "city": "Hollywood",
          "country": "United States",
          "facility": "Memorial Regional Hospital/Joe DiMaggio Children's Hospital"
        },
        {
          "city": "Jacksonville",
          "country": "United States",
          "facility": "Nemours Children's Clinic-Jacksonville"
        },
        {
          "city": "Miami",
          "country": "United States",
          "facility": "University of Miami Miller School of Medicine-Sylvester Cancer Center"
        },
        {
          "city": "Orlando",
          "country": "United States",
          "facility": "AdventHealth Orlando"
        },
        {
          "city": "Orlando",
          "country": "United States",
          "facility": "Arnold Palmer Hospital for Children"
        },
        {
          "city": "Orlando",
          "country": "United States",
          "facility": "Nemours Children's Hospital"
        },
        {
          "city": "Pensacola",
          "country": "United States",
          "facility": "Nemours Children's Clinic - Pensacola"
        },
        {
          "city": "St. Petersburg",
          "country": "United States",
          "facility": "Johns Hopkins All Children's Hospital"
        },
        {
          "city": "Tampa",
          "country": "United States",
          "facility": "Saint Joseph's Hospital/Children's Hospital-Tampa"
        },
        {
          "city": "West Palm Beach",
          "country": "United States",
          "facility": "Saint Mary's Medical Center"
        },
        {
          "city": "Atlanta",
          "country": "United States",
          "facility": "Children's Healthcare of Atlanta - Arthur M Blank Hospital"
        },
        {
          "city": "Honolulu",
          "country": "United States",
          "facility": "Kapiolani Medical Center for Women and Children"
        },
        {
          "city": "Boise",
          "country": "United States",
          "facility": "Saint Luke's Cancer Institute - Boise"
        },
        {
          "city": "Chicago",
          "country": "United States",
          "facility": "Lurie Children's Hospital-Chicago"
        },
        {
          "city": "Chicago",
          "country": "United States",
          "facility": "University of Chicago Comprehensive Cancer Center"
        },
        {
          "city": "Oak Lawn",
          "country": "United States",
          "facility": "Advocate Children's Hospital-Oak Lawn"
        },
        {
          "city": "Park Ridge",
          "country": "United States",
          "facility": "Advocate Children's Hospital-Park Ridge"
        },
        {
          "city": "Peoria",
          "country": "United States",
          "facility": "OSF Children's Hospital of Illinois"
        },
        {
          "city": "Springfield",
          "country": "United States",
          "facility": "Southern Illinois University School of Medicine"
        },
        {
          "city": "Indianapolis",
          "country": "United States",
          "facility": "Riley Hospital for Children"
        },
        {
          "city": "Indianapolis",
          "country": "United States",
          "facility": "Ascension Saint Vincent Indianapolis Hospital"
        },
        {
          "city": "Des Moines",
          "country": "United States",
          "facility": "Blank Children's Hospital"
        },
        {
          "city": "Lexington",
          "country": "United States",
          "facility": "University of Kentucky/Markey Cancer Center"
        },
        {
          "city": "Louisville",
          "country": "United States",
          "facility": "Norton Children's Hospital"
        },
        {
          "city": "New Orleans",
          "country": "United States",
          "facility": "Children's Hospital New Orleans"
        },
        {
          "city": "New Orleans",
          "country": "United States",
          "facility": "Ochsner Medical Center Jefferson"
        },
        {
          "city": "Scarborough",
          "country": "United States",
          "facility": "Maine Children's Cancer Program"
        },
        {
          "city": "Baltimore",
          "country": "United States",
          "facility": "Sinai Hospital of Baltimore"
        },
        {
          "city": "Baltimore",
          "country": "United States",
          "facility": "Johns Hopkins University/Sidney Kimmel Cancer Center"
        },
        {
          "city": "Boston",
          "country": "United States",
          "facility": "Dana-Farber Cancer Institute"
        },
        {
          "city": "Worcester",
          "country": "United States",
          "facility": "UMass Memorial Medical Center - University Campus"
        },
        {
          "city": "Ann Arbor",
          "country": "United States",
          "facility": "C S Mott Children's Hospital"
        },
        {
          "city": "Grand Rapids",
          "country": "United States",
          "facility": "Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital"
        },
        {
          "city": "Kalamazoo",
          "country": "United States",
          "facility": "Bronson Methodist Hospital"
        },
        {
          "city": "Minneapolis",
          "country": "United States",
          "facility": "University of Minnesota/Masonic Cancer Center"
        },
        {
          "city": "Jackson",
          "country": "United States",
          "facility": "University of Mississippi Medical Center"
        },
        {
          "city": "Kansas City",
          "country": "United States",
          "facility": "Children's Mercy Hospitals and Clinics"
        },
        {
          "city": "St Louis",
          "country": "United States",
          "facility": "Washington University School of Medicine"
        },
        {
          "city": "St Louis",
          "country": "United States",
          "facility": "Mercy Hospital Saint Louis"
        },
        {
          "city": "Omaha",
          "country": "United States",
          "facility": "Children's Hospital and Medical Center of Omaha"
        },
        {
          "city": "Las Vegas",
          "country": "United States",
          "facility": "Alliance for Childhood Diseases/Cure 4 the Kids Foundation"
        },
        {
          "city": "Lebanon",
          "country": "United States",
          "facility": "Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center"
        },
        {
          "city": "Hackensack",
          "country": "United States",
          "facility": "Hackensack University Medical Center"
        },
        {
          "city": "Morristown",
          "country": "United States",
          "facility": "Morristown Medical Center"
        },
        {
          "city": "New Brunswick",
          "country": "United States",
          "facility": "Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital"
        },
        {
          "city": "Paterson",
          "country": "United States",
          "facility": "Saint Joseph's Regional Medical Center"
        },
        {
          "city": "Albany",
          "country": "United States",
          "facility": "Albany Medical Center"
        },
        {
          "city": "Buffalo",
          "country": "United States",
          "facility": "Roswell Park Cancer Institute"
        },
        {
          "city": "New Hyde Park",
          "country": "United States",
          "facility": "The Steven and Alexandra Cohen Children's Medical Center of New York"
        },
        {
          "city": "New York",
          "country": "United States",
          "facility": "Laura and Isaac Perlmutter Cancer Center at NYU Langone"
        },
        {
          "city": "New York",
          "country": "United States",
          "facility": "Memorial Sloan Kettering Cancer Center"
        },
        {
          "city": "New York",
          "country": "United States",
          "facility": "NYP/Weill Cornell Medical Center"
        },
        {
          "city": "Rochester",
          "country": "United States",
          "facility": "University of Rochester"
        },
        {
          "city": "Syracuse",
          "country": "United States",
          "facility": "State University of New York Upstate Medical University"
        },
        {
          "city": "The Bronx",
          "country": "United States",
          "facility": "Montefiore Medical Center - Moses Campus"
        },
        {
          "city": "Valhalla",
          "country": "United States",
          "facility": "New York Medical College"
        },
        {
          "city": "Chapel Hill",
          "country": "United States",
          "facility": "UNC Lineberger Comprehensive Cancer Center"
        },
        {
          "city": "Charlotte",
          "country": "United States",
          "facility": "Carolinas Medical Center/Levine Cancer Institute"
        },
        {
          "city": "Durham",
          "country": "United States",
          "facility": "Duke University Medical Center"
        },
        {
          "city": "Greenville",
          "country": "United States",
          "facility": "East Carolina University"
        },
        {
          "city": "Winston-Salem",
          "country": "United States",
          "facility": "Wake Forest University Health Sciences"
        },
        {
          "city": "Fargo",
          "country": "United States",
          "facility": "Sanford Broadway Medical Center"
        },
        {
          "city": "Akron",
          "country": "United States",
          "facility": "Children's Hospital Medical Center of Akron"
        },
        {
          "city": "Cincinnati",
          "country": "United States",
          "facility": "Cincinnati Children's Hospital Medical Center"
        },
        {
          "city": "Cleveland",
          "country": "United States",
          "facility": "Rainbow Babies and Childrens Hospital"
        },
        {
          "city": "Dayton",
          "country": "United States",
          "facility": "Dayton Children's Hospital"
        },
        {
          "city": "Toledo",
          "country": "United States",
          "facility": "ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital"
        },
        {
          "city": "Oklahoma City",
          "country": "United States",
          "facility": "University of Oklahoma Health Sciences Center"
        },
        {
          "city": "Allentown",
          "country": "United States",
          "facility": "Lehigh Valley Hospital-Cedar Crest"
        },
        {
          "city": "Danville",
          "country": "United States",
          "facility": "Geisinger Medical Center"
        },
        {
          "city": "Hershey",
          "country": "United States",
          "facility": "Penn State Children's Hospital"
        },
        {
          "city": "Philadelphia",
          "country": "United States",
          "facility": "Children's Hospital of Philadelphia"
        },
        {
          "city": "Pittsburgh",
          "country": "United States",
          "facility": "Children's Hospital of Pittsburgh of UPMC"
        },
        {
          "city": "Providence",
          "country": "United States",
          "facility": "Rhode Island Hospital"
        },
        {
          "city": "Columbia",
          "country": "United States",
          "facility": "Prisma Health Richland Hospital"
        },
        {
          "city": "Greenville",
          "country": "United States",
          "facility": "BI-LO Charities Children's Cancer Center"
        },
        {
          "city": "Sioux Falls",
          "country": "United States",
          "facility": "Sanford USD Medical Center - Sioux Falls"
        },
        {
          "city": "Knoxville",
          "country": "United States",
          "facility": "East Tennessee Childrens Hospital"
        },
        {
          "city": "Memphis",
          "country": "United States",
          "facility": "Saint Jude Children's Research Hospital"
        },
        {
          "city": "Nashville",
          "country": "United States",
          "facility": "The Children's Hospital at TriStar Centennial"
        },
        {
          "city": "Nashville",
          "country": "United States",
          "facility": "Vanderbilt University/Ingram Cancer Center"
        },
        {
          "city": "Austin",
          "country": "United States",
          "facility": "Dell Children's Medical Center of Central Texas"
        },
        {
          "city": "Corpus Christi",
          "country": "United States",
          "facility": "Driscoll Children's Hospital"
        },
        {
          "city": "Dallas",
          "country": "United States",
          "facility": "Medical City Dallas Hospital"
        },
        {
          "city": "Dallas",
          "country": "United States",
          "facility": "UT Southwestern/Simmons Cancer Center-Dallas"
        },
        {
          "city": "El Paso",
          "country": "United States",
          "facility": "El Paso Children's Hospital"
        },
        {
          "city": "Fort Worth",
          "country": "United States",
          "facility": "Cook Children's Medical Center"
        },
        {
          "city": "Houston",
          "country": "United States",
          "facility": "Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center"
        },
        {
          "city": "San Antonio",
          "country": "United States",
          "facility": "Children's Hospital of San Antonio"
        },
        {
          "city": "San Antonio",
          "country": "United States",
          "facility": "Methodist Children's Hospital of South Texas"
        },
        {
          "city": "Temple",
          "country": "United States",
          "facility": "Scott and White Memorial Hospital"
        },
        {
          "city": "Charlottesville",
          "country": "United States",
          "facility": "University of Virginia Cancer Center"
        },
        {
          "city": "Norfolk",
          "country": "United States",
          "facility": "Children's Hospital of The King's Daughters"
        },
        {
          "city": "Richmond",
          "country": "United States",
          "facility": "VCU Massey Comprehensive Cancer Center"
        },
        {
          "city": "Roanoke",
          "country": "United States",
          "facility": "Carilion Children's"
        },
        {
          "city": "Seattle",
          "country": "United States",
          "facility": "Seattle Children's Hospital"
        },
        {
          "city": "Spokane",
          "country": "United States",
          "facility": "Providence Sacred Heart Medical Center and Children's Hospital"
        },
        {
          "city": "Green Bay",
          "country": "United States",
          "facility": "Saint Vincent Hospital Cancer Center Green Bay"
        },
        {
          "city": "Milwaukee",
          "country": "United States",
          "facility": "Children's Hospital of Wisconsin"
        },
        {
          "city": "San Juan",
          "country": "Puerto Rico",
          "facility": "University Pediatric Hospital"
        }
      ],
      "outcomes": {
        "other": [
          "3-year EFS of infants with KMT2A-R ALL treated on Arm B",
          "Use of high-throughput sequencing (HTS) for MRD detection in infant ALL compared to centralized flow cytometry",
          "PK of calaspargase pegol in infants with ALL",
          "Incidence of CD19-negative relapse and myeloid switch relapse with protocol therapy",
          "Impact of venetoclax in combination with chemotherapy on T-cell subsets and function",
          "Feasibility of T-cell collection and success of T-cell manufacturing for infants with KMT2A-R ALL who receive chimeric antigen receptor (CAR) T-cell therapy",
          "Predictors of response and resistance to venetoclax and overall protocol therapy",
          "Impact of subsequent anti-cancer therapy on overall survival",
          "Overall survival (OS) rates"
        ],
        "primary": [
          "Incidence of dose-limiting toxicities (DLTs) (safety phase)",
          "Incidence of DLTs (expansion phase)",
          "Minimal residual disease (MRD)-negative remission rate"
        ],
        "secondary": [
          "MRD-negative remission rate",
          "Event free survival (EFS) rates of infants with KMT2A-R ALL",
          "3-year EFS of infants with KMT2A-R ALL",
          "Proportion of KMT2A-germline (G) patients in Arm C who are able to receive all treatment cycles before maintenance",
          "3-year EFS of infants with KMT2A-G ALL treated on Arm C",
          "Pharmacokinetics (PK) of venetoclax in infants"
        ]
      },
      "eligibility": {
        "sex": "ALL",
        "criteria": "Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321\n* 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\n* 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\n\n  * Diagnostic immunophenotype: Leukemia cells must express CD19\n\nExclusion Criteria:\n\n* Patients with Down Syndrome\n* Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy\n* 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:\n\n  * Steroid pretreatment:\n\n    * 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\n    * Inhaled and topical steroids are not considered pretreatment\n    * 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\n  * Intrathecal cytarabine or methotrexate:\n\n    * An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility\n    * 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\n  * Hydroxyurea:\n\n    * Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility\n* All patients and/or their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met",
        "maximumAge": "365 Days",
        "healthyVolunteers": false
      },
      "enrollment": {
        "type": "ESTIMATED",
        "count": 153
      },
      "startDate": "2025-06-05",
      "completionDate": "2028-12-31",
      "lastUpdated": "2026-10-27T00:00:00.000Z",
      "firstPosted": "2024-03-19T00:00:00.000Z",
      "resultsAvailable": false,
      "sourceRegistries": [
        "clinicaltrials_gov"
      ],
      "sourceUrls": [
        "https://clinicaltrials.gov/study/NCT06317662"
      ]
    },
    "identifiers": [
      {
        "idType": "nct",
        "idValue": "NCT06317662",
        "declaredBy": "clinicaltrials_gov"
      }
    ],
    "sourceRecords": [
      {
        "registry": "clinicaltrials_gov",
        "registryName": "ClinicalTrials.gov",
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