Children’s Oncology Group AALL0434: A phase III randomized clinical trial testing nelarabine in newly diagnosed T-cell acute lymphoblastic leukemia
Journal of Clinical Oncology Oct 04, 2020
Dunsmore KP, Winter SS, Devidas M, et al. - In patients with relapsed and refractory T-cell acute lymphoblastic leukemia (T-ALL), nelarabine is effective in inducing remission, so researchers conducted this analysis to assess its role in newly diagnosed disease. The Children’s Oncology Group trial AALL0434 recruited 1,562 evaluable individuals from 2007 to 2014 with T-ALL aged 1-31 years who received the augmented Berlin-Frankfurt-Muenster (ABFM) regimen with a 2 × 2 pseudo-factorial randomization to receive escalating-dose methotrexate (MTX) without leucovorin rescue plus pegaspargase or high-dose MTX with leucovorin rescue. According to the data, the 5-year event-free and overall survival rates were 83.7% ± 1.1% and 89.5% ± 0.9%, respectively. For patients with T-ALL randomly assigned to nelarabine and no nelarabine, the 5-year disease-free survival (DFS) rates were 88.2% ± 2.4% and 82.1% ± 2.7%, respectively. For children and young adults with newly diagnosed T-ALL, adding of nelarabine to ABFM therapy improved DFS with no increased toxicity.
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