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JALSG T-ALL213-O: Nelarabine combined chemotherapy in newly diagnosed T-ALL
Development of monoclonal antibody- or CAR-based immunotherapies for T-ALL remains challenging due to life-threatening T-cell immunodeficiency and fratricide of CAR-T cells resulting from shared target antigen expression between normal and malignant T cells.1 Nelarabine, a DNA-terminating nucleoside prodrug, preferentially accumulates in T lymphoblasts and has shown antitumor activity in patients with R/R T-ALL.1 The single-arm, multicenter phase II JALSG T-ALL213-O trial (UMIN-CTR UMIN000010642) investigated nelarabine combined chemotherapy (nelarabine in the second induction for patients without CR after first induction, and incorporated into C3 and C5 consolidation phases) in patients with newly diagnosed T-ALL.1 28 patients were enrolled and 24 received the first cycle of induction. The primary end point was EFS at 3 years after registration, defined as the time from registration to failure to achieve CR, relapse, death, or the last visit. Results were published by Hayakawa et al.1 in Cancer Science. Findings were compared with the previous T-ALL202-O study (UMIN-CTR C000000063) of high-dose methotrexate consolidation therapy for ALL without nelarabine.1
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| Key learnings |
| The CR rate following first induction was 75%, increasing to 100% after a second induction with nelarabine, with a total CR rate of 88%. The CR rate of second induction therapy in T-ALL213-O was significantly higher than in T-ALL202-O (100% vs 29%, respectively, p = 0.038). |
| The 5-year EFS and OS rates were 66% and 70%, respectively. Despite higher CR rates than those observed in the T-ALL202-O trial, nelarabine treatment did not significantly improve long-term survival. |
| A major concern was severe neurotoxicity. Grade 3 peripheral neuropathy occurred in 50% of nelarabine-treated patients; a significantly higher incidence than previously reported in T-ALL202-O. |
| While nelarabine enhances initial response rates, its integration into intensive chemotherapy regimens must be carefully considered due the risk of neurotoxicity. Further studies should optimize dosage and patient selection to balance efficacy and safety. |
Abbreviations: C3, Cycle 3, C5, Cycle 5; CAR, chimeric antigen receptor; CR, complete response; EFS, event-free survival; OS, overall survival; R/R, relapsed/refractory; T-ALL, T-cell acute lymphoblastic leukemia.
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