nctId: NCT06317662 id: NCI-2024-01994 id: NCI-2024-01994 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: AALL2321 type: OTHER domain: Children's Oncology Group id: AALL2321 type: OTHER domain: CTEP id: U10CA180886 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180886 briefTitle: 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 overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2027-12-21 date: 2027-12-21 date: 2024-03-19 date: 2024-04-25 name: National Cancer Institute (NCI) class: NIH briefSummary: 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. conditions: Acute Leukemia of Ambiguous Lineage conditions: B Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 171 type: ESTIMATED name: Asparaginase Erwinia chrysanthemi name: Biospecimen Collection name: Blinatumomab name: Bone Marrow Aspiration name: Calaspargase Pegol name: Computed Tomography name: Cyclophosphamide name: Cytarabine name: Daunorubicin name: Dexamethasone name: Doxorubicin name: Echocardiography name: FDG-Positron Emission Tomography name: Leucovorin name: Lumbar Puncture name: Magnetic Resonance Imaging name: Mercaptopurine name: Methotrexate name: Multigated Acquisition Scan name: Pegaspargase name: Prednisolone name: Prednisone name: Therapeutic Hydrocortisone name: Thioguanine name: Venetoclax name: Vincristine measure: Incidence of dose-limiting toxicities (DLTs) (safety phase) measure: Incidence of DLTs (expansion phase) measure: Minimal residual disease (MRD)-negative remission rate measure: Event free survival (EFS) rates of infants with KMT2A-R acute lymphoblastic leukemia (ALL) measure: 3-year EFS of infants with KMT2A-R ALL measure: Proportion of KMT2A-G patients in Arm C who are able to receive all treatment cycles before maintenance measure: Pharmacokinetics (PK) of venetoclax in infants measure: 3-year EFS of infants with KMT2A-R ALL treated on Arm B measure: 3-year EFS of infants with KMT2A-G ALL treated on Arm C measure: Use of high-throughput sequencing (HTS) for MRD detection in infant ALL compared to centralized flow cytometry measure: PK of calaspargase pegol in infants with ALL measure: Incidence of CD19-negative relapse and myeloid switch relapse with protocol therapy measure: Impact of venetoclax in combination with chemotherapy on T-cell subsets and function measure: Feasibility of T-cell collection and success of T-cell manufacturing for infants with KMT2A-R ALL who receive chimeric antigen receptor T-cell therapy measure: Predictors of response and resistance to venetoclax and overall protocol therapy measure: Impact of subsequent anti-cancer therapy on overall survival sex: ALL maximumAge: 365 Days stdAges: CHILD hasResults: False