[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: Keizo Horibe, Tetsuya Takimoto, Toshiya Yokozawa, Atsushi Makimoto, Yukio Kobayashi, Chitose Ogawa, Ryuzo Ohno, Nobuyuki Koh, Koichi Katsura, Kensei Tobinai
• Journal: [Rinsho ketsueki] The Japanese journal of clinical hematology (Rinsho Ketsueki) Vol. 52 Issue 6 Pg. 406-15 (Jun 2011) ISSN: 0485-1439 [Print] Japan
• PMID: 21737993 (Publication Type: Clinical Trial, Phase I, Journal Article)

Chemical References

• Arabinonucleosides
• Arabinonucleotides
• nelarabine
• 9-beta-D-arabinofuranosylguanosine 5'-triphosphate
• Guanosine Triphosphate

Topics

• Adolescent
• Adult
• Arabinonucleosides (administration & dosage, adverse effects, pharmacokinetics)
• Arabinonucleotides (metabolism)
• Child
• Drug Administration Schedule
• Female
• Guanosine Triphosphate (analogs & derivatives, metabolism)
• Humans
• Male
• Middle Aged
• Precursor Cell Lymphoblastic Leukemia-Lymphoma (drug therapy)
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma (drug therapy)
• Recurrence
• T-Lymphocytes (metabolism)
• Treatment Outcome
• Young Adult