Reduced-dose Chemotherapy and Blinatumomab As Induction Treatment for Newly Diagnosed Ph-negative B-cell Precursor Acute Lymphoblastic Leukemia: a Phase 2 Trial
Journal of Hematology & Oncology(2024)
摘要
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 Trial registration: https://www.clinicaltrials.Gov . Identifier NCT05557110.
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关键词
Blinatumomab,Reduced-dose chemotherapy,Induction treatment,B-cell precursor acute lymphoblastic leukemia,Philadelphia chromosome-negative
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