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Reduced-dose chemotherapy plus blinatumomab in patients with Ph− BCP-ALL: Results from a phase II trial
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A phase II trial (NCT05557110) assessed the safety and efficacy of RDC plus blinatumomab as a first-line induction treatment in 35 patients aged 15–65 years with Ph− BCP-ALL.1 Patients received blinatumomab for 2 weeks, which was extended to 4 weeks in patients with no CR/CRi. Results from this trial were published in the Journal of Hematology & Oncology by Lu et al.1 |
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RDC combined with 2 weeks of blinatumomab resulted in a CRc rate of 94%, with 86% of patients achieving MRD negativity. In two patients, blinatumomab treatment was extended to 4 weeks. For all patients with either 2 or 4 weeks of blinatumomab, CRc and MRD negativity rates were 100% and 89%, respectively. |
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At a median follow-up of 11.5 months, the estimated 1-year PFS and OS rates were 82.2% and 97.1%, respectively. |
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RDC plus blinatumomab was well tolerated, with no induction-related deaths within 4 weeks. Grade 3–4 neutropenia and thrombocytopenia occurred in 69% and 23% of patients, respectively. CRS occurred in 54% of patients, including Grade 3 CRS in 9% and ICANS (all Grade 1) in 14% of patients. |
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These findings demonstrate the safety and efficacy of RDC plus blinatumomab as a first-line therapy for younger patients with Ph− BCP-ALL, suggesting that the adoption of less intensive, more targeted induction regimens may reduce chemotherapy-related toxicity while maintaining high remission and MRD negativity rates. Further studies are warranted to confirm these findings in larger populations with longer follow-ups. |
Abbreviations: BCP-ALL, B-cell precursor acute lymphoblastic leukemia; CR, complete remission; CRc, composite CR; CRi, CR with incomplete count recovery; CRS, cytokine release syndrome; ICANS, immune-effector cell-associated neurotoxicity syndrome; MRD, measurable residual disease; OS, overall survival; PFS, progression-free survival; Ph−, Philadelphia negative; RDC, reduced-dose chemotherapy.
- Lu J, Qiu H, Wang Y, et al. Reduced-dose chemotherapy and blinatumomab as induction treatment for newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia: A phase 2 trial. J Hematol Oncol. 2024;17(1):79. DOI: 1186/s13045-024-01597-8
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