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
|