再発・難治性T細胞性急性リンパ性白血病およびT細胞性リンパ芽球性リンパ腫に対するネララビンの第I相試験  [in Japanese] Phase I study of nelarabine in patients with relapsed or refractory T-ALL/T-LBL  [in Japanese]

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Abstract

日本人成人及び小児のT-ALL/T-LBL患者を対象とした第I相試験を実施した。成人ではネララビン1,500 mg/m<sup>2</sup>/日を1, 3, 5日に投与,その後16日間休薬,また小児ではネララビン650 mg/m<sup>2</sup>/日を連日5日間投与,その後16日間休薬とするレジメンの忍容性が確認された。安全性評価対象は成人7例,小児6例で,有害事象は全例に発現した。高頻度の事象は,成人では傾眠,悪心,小児では白血球数減少,リンパ球数減少であった。グレード3/4の有害事象を成人,小児各5例に認めた。臨床検査値異常が主で,用量制限毒性は認めなかった。有効性評価対象は成人7例,小児4例で,完全寛解到達は成人1例,小児2例であった。T細胞内ara-GTPと有効性との関連が示唆された。

The safety, tolerability, pharmacokinetics and efficacy of nelarabine were evaluated in adult and pediatric patients with relapsed or refractory T-ALL/T-LBL. Adult patients received nelarabine i.v. over 2 hours on days 1, 3 and 5 in every 21 days, and pediatric patients received this regimen over 1 hour for 5 consecutive days in every 21 days. Safety was evaluated in 7 adult and 6 pediatric patients. Adverse events (AEs) were reported in all patients. Most frequently reported AEs included somnolence and nausea in adult patients and leukopenia and lymphocytopenia in pediatric patients. Five grade 3/4 AEs were reported in both adult and pediatric patients, most of which were hematologic events. There were no dose-limiting toxicities. Efficacy was evaluated in 7 adult and 4 pediatric patients. Complete response was noted in 1 adult and 2 pediatric patients. Higher intracellular ara-GTP concentrations were suggested to be associated with efficacy. Japanese adult and pediatric patients with T-ALL/T-LBL well tolerated nelarabine treatment, warranting further investigation.

Journal

  • Rinsho Ketsueki

    Rinsho Ketsueki 52(6), 406-415, 2011

    The Japanese Society of Hematology

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