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Phase II study of clofarabine in pediatric patients with refractory or relapsed acute myeloid leukemia.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2009 Sep 10; Vol. 27 (26), pp. 4392-7. Date of Electronic Publication: 2009 Aug 03. - Publication Year :
- 2009
-
Abstract
- Purpose: To determine the efficacy and safety of clofarabine in pediatric patients with refractory or relapsed acute myeloid leukemia (AML).<br />Patients and Methods: A phase II, open-label, multicenter study was conducted with single-agent clofarabine in pediatric patients with refractory or relapsed AML. Clofarabine was administered intravenously over 2 hours at the pediatric maximum-tolerated dose (MTD) of 52 mg/m(2) daily for 5 consecutive days. Cycles were repeated every 2 to 6 weeks. Responses determined by an independent response review panel.<br />Results: The 42 patients treated on the study had a median age of 13 years (range, 2 to 22 years) and had received a median number of two (range, one to five) prior regimens. The response rate was 26% and included one complete response without platelet recovery and 10 partial responses. The median duration of response was 20 weeks (range, 2 to >or= 156 weeks). Six of 28 patients who were refractory to the immediately preceding therapy achieved response. Thirteen patients (31%), including seven responders, proceeded to hematopoietic stem-cell transplantation (HSCT) after treatment with clofarabine and survived between 24 to >or= 160 weeks. Five patients (12%) remain alive post-transplantation at >or= 63, >or= 71, >or= 86, >or= 114, and >or= 130 weeks. The most common grade 3 or greater adverse events without regard to causality were febrile neutropenia, catheter-related infection, epistaxis, hypotension, nausea, and fever. Transient elevation of liver enzymes and hypokalemia occurred frequently. Five patients died within 30 days of clofarabine administration secondary to progressive disease, and another five died as a result of an adverse event.<br />Conclusion: Clofarabine is active in pediatric patients with multiply relapsed or refractory AML. Responses allowed several refractory patients to proceed to HSCT. The toxicity profile was expected in this patient population.
- Subjects :
- Acute Disease
Adenine Nucleotides adverse effects
Adolescent
Antineoplastic Agents adverse effects
Antineoplastic Agents therapeutic use
Arabinonucleosides adverse effects
Child
Child, Preschool
Clofarabine
Drug Resistance, Neoplasm
Female
Fever etiology
Hematopoietic Stem Cell Transplantation adverse effects
Hematopoietic Stem Cell Transplantation methods
Humans
Leukemia, Myeloid surgery
Male
Nausea etiology
Neutropenia etiology
Recurrence
Remission Induction
Treatment Outcome
Young Adult
Adenine Nucleotides therapeutic use
Arabinonucleosides therapeutic use
Leukemia, Myeloid drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 27
- Issue :
- 26
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 19652076
- Full Text :
- https://doi.org/10.1200/JCO.2008.18.8706