{
    "abstract": "Blinatumomab has emerged as a promising component of first-line therapy for acute B-cell precursor lymphoblastic leukemia (BCP-ALL), bolstering treatment efficacy. To mitigate CD19 selection pressure and reduce the incidence of blinatumomab-associated toxicities, pre-treatment chemotherapy is recommended before administering blinatumomab. From September 2022 to December 2023, we conducted a single-arm, multicenter, phase 2 trial (NCT05557110) in newly diagnosed Philadelphia chromosome-negative BCP-ALL (Ph-negative BCP-ALL) patients. Participants received induction treatment with reduced-dose chemotherapy (RDC), comprising idarubicin, vindesine, and dexamethasone over 7 days, followed by 2 weeks of blinatumomab. Those failing to achieve composite complete remission (CRc) received an additional 2 weeks of blinatumomab. The primary endpoint was the CRc rate post initial induction treatment. Of the 35 enrolled patients, 33 (94%) achieved CRc after 2 weeks of blinatumomab, with 30 (86%) achieving measurable residual disease (MRD) negativity. Two patients extended blinatumomab to 4 weeks. With either 2 or 4 weeks of blinatumomab treatment, all patients achieved CR (35/35) and 89% (31/35) were MRD negativity. The median time to CR was 22 days. Immune effector cell-associated neurotoxicity syndrome was limited (14%, all grade 1). Non-hematological adverse events of grade 3 or higher included pneumonia (17%), sepsis (6%), and cytokine release syndrome (9%). With a median follow-up of 11.5 months, estimated 1-year overall survival and 1-year progression-free survival rates were 97.1% and 82.2%, respectively. These findings affirm that RDC followed by blinatumomab is an effective and well-tolerated induction regimen for newly diagnosed Ph-negative BCP-ALL, supporting a shift towards less intensive and more targeted therapeutic approaches. Trial registration: https://www.clinicaltrials.Gov . Identifier NCT05557110.",
    "authors": [
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Jing",
            "initials": "J",
            "lastname": "Lu"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Huiying",
            "initials": "H",
            "lastname": "Qiu"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Ying",
            "initials": "Y",
            "lastname": "Wang"
        },
        {
            "affiliation": "Department of Hematology, The Affiliated Wuxi People's Hospital of Nanjing Medical University, WuXi, China.",
            "firstname": "Xin",
            "initials": "X",
            "lastname": "Zhou"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Haiping",
            "initials": "H",
            "lastname": "Dai"
        },
        {
            "affiliation": "Department of Hematology, Affiliated Changzhou Second Hospital of Nanjing Medical University, Changzhou, Jiangsu, China.",
            "firstname": "Xuzhang",
            "initials": "X",
            "lastname": "Lu"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Xiaofei",
            "initials": "X",
            "lastname": "Yang"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.\nDepartment of Hematology, Soochow Hopes Hematonosis Hospital, Suzhou, China.",
            "firstname": "Bin",
            "initials": "B",
            "lastname": "Gu"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China.",
            "firstname": "Ming",
            "initials": "M",
            "lastname": "Hong"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Miao",
            "initials": "M",
            "lastname": "Miao"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China.",
            "firstname": "Ruinan",
            "initials": "R",
            "lastname": "Lu"
        },
        {
            "affiliation": "Department of Hematology, Soochow Hopes Hematonosis Hospital, Suzhou, China.",
            "firstname": "Jun",
            "initials": "J",
            "lastname": "Wang"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Qian",
            "initials": "Q",
            "lastname": "Wu"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Mengxing",
            "initials": "M",
            "lastname": "Xue"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Yun",
            "initials": "Y",
            "lastname": "Wang"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Ailing",
            "initials": "A",
            "lastname": "Deng"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Yaoyao",
            "initials": "Y",
            "lastname": "Shen"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Yin",
            "initials": "Y",
            "lastname": "Liu"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China.",
            "firstname": "Xueqing",
            "initials": "X",
            "lastname": "Dou"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China.",
            "firstname": "Yutian",
            "initials": "Y",
            "lastname": "Lei"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China. drwudepei@163.com.",
            "firstname": "Depei",
            "initials": "D",
            "lastname": "Wu"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China. zhuyu@jsph.org.cn.",
            "firstname": "Yu",
            "initials": "Y",
            "lastname": "Zhu"
        },
        {
            "affiliation": "Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, National Clinical Research Center for Hematologic Diseases, Suzhou, Jiangsu, China. chensuning@sina.com.",
            "firstname": "Suning",
            "initials": "S",
            "lastname": "Chen"
        }
    ],
    "conclusions": null,
    "copyrights": "\u00a9 2024. The Author(s).",
    "doi": "10.1186/s13045-024-01597-8\n10.1002/cncr.20668\n10.1182/bloodadvances.2022009596\n10.1016/S2352-3026(22)00319-2\n10.3324/haematol.2021.280078\n10.1182/blood.2020006287\n10.1182/blood-2023-186998\n10.1182/blood-2023-180472\n10.1001/jama.2021.0987\n10.1002/cncr.23819\n10.1016/S2352-3026(22)00285-X\n10.1056/NEJMoa1609783",
    "journal": "Journal of hematology & oncology",
    "keywords": [
        "B-cell precursor acute lymphoblastic leukemia",
        "Blinatumomab",
        "Induction treatment",
        "Philadelphia chromosome-negative",
        "Reduced-dose chemotherapy"
    ],
    "methods": null,
    "publication_date": "2024-09-02",
    "pubmed_id": "39218935\n15481055\n37276451\n36402146\n35263986\n32881995\n33651091\n18720356\n9716583\n36279879\n28249141",
    "results": null,
    "title": "Reduced-dose chemotherapy and blinatumomab as induction treatment for newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia: a phase 2 trial.",
    "xml": "<Element 'PubmedArticle' at 0x78850241da30>"
}