Safe integration of nelarabine into intensive chemotherapy in newly diagnosed T-cell acute lymphoblastic leukemia: Children's Oncology Group Study AALL0434

Pediatric Blood & Cancer
Stuart S WinterStephen P Hunger

Abstract

Nelarabine has shown impressive single agent clinical activity in T-cell acute lymphoblastic leukemia (T-ALL), but has been associated with significant neurotoxicities in heavily pre-treated patients. We showed previously that it was safe to add nelarabine to a BFM-86 chemotherapy backbone (AALL00P2). Children's Oncology Group (COG) AALL0434 is a Phase III study designed to test the safety and efficacy of nelarabine when incorporated into a COG augmented BFM-based regimen, which increases exposure to agents with potential neurotoxicity compared to the historical AALL00P2 regimen. AALL0434 included a safety phase to assess nelarabine toxicity. Patients with high-risk (HR) T-ALL were randomized to receive Capizzi-style escalating methotrexate (MTX) plus pegaspargase or high dose (HD) MTX with/without six five-days courses of nelarabine. We report results from 94 patients who participated in the initial safety phase of the study. There were no differences in the incidence of peripheral motor neuropathies, sensory neuropathies or central neurotoxicities among those randomized to the nelarabine (n = 47) and non-nelarabine arms (n = 47). The addition of nelarabine to COG-augmented BFM chemotherapy regimen is safe and feasible. The on...Continue Reading

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Citations

Dec 29, 2015·Experimental Hematology·Catherine HoofdAndrew P Weng
Jul 22, 2015·Cancer·Sarah K TasianStephen P Hunger
Mar 19, 2016·British Journal of Haematology·Birgit BurkhardtSherrie L Perkins
Dec 19, 2015·European Journal of Haematology·Renato BassanSergio Cortelazzo
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Jul 27, 2017·Pediatrics International : Official Journal of the Japan Pediatric Society·Takuyo KanayamaHajime Hosoi
Feb 15, 2018·Current Hematologic Malignancy Reports·Victor M Orellana-Noia, Michael G Douvas
Aug 24, 2018·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Stuart S WinterStephen P Hunger
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Aug 20, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Kimberly P DunsmoreStephen P Hunger
Oct 26, 2016·Journal of Hematology & Oncology·Annalisa LonettiFrancesca Chiarini
Mar 3, 2019·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Kimberly M LauAaron Goodman
Jun 20, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Robert J HayashiCatherine M Bollard
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