title: [Phase I study of nelarabine in patients with relapsed or refractory T-ALL/T-LBL].
abstract: 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.
authors: Nagoya Medical Center Clinical Research Center.
authors: Keizo
authors: K
authors: Horibe
authors: Tetsuya
authors: T
authors: Takimoto
authors: Toshiya
authors: T
authors: Yokozawa
authors: Atsushi
authors: A
authors: Makimoto
authors: Yukio
authors: Y
authors: Kobayashi
authors: Chitose
authors: C
authors: Ogawa
authors: Ryuzo
authors: R
authors: Ohno
authors: Nobuyuki
authors: N
authors: Koh
authors: Koichi
authors: K
authors: Katsura
authors: Kensei
authors: K
authors: Tobinai
mesh_terms: D000293:Adolescent; D000328:Adult; D001087:Arabinonucleosides / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D001088:Arabinonucleotides / Q000378:metabolism; D002648:Child; D004334:Drug Administration Schedule; D005260:Female; D006160:Guanosine Triphosphate / Q000031:analogs & derivatives / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy*; D054218:Precursor T-Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy*; D012008:Recurrence; D013601:T-Lymphocytes / Q000378:metabolism; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001087:Arabinonucleosides; D001088:Arabinonucleotides; C104457:nelarabine; C022206:9-beta-D-arabinofuranosylguanosine 5'-triphosphate; D006160:Guanosine Triphosphate