Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
12
pubmed:dateCreated
2009-12-17
pubmed:abstractText
This Phase I study of clofarabine with etoposide and cyclophosphamide for children with relapsed/refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML) was conducted to determine the maximum tolerated dose (MTD), dose-limiting toxicities and the recommended phase 2 doses (RP2Ds). All three drugs were administered for five consecutive days in induction and four consecutive days in consolidation, for a maximum of eight cycles. A total of 25 patients (20 ALL and 5 AML) were enrolled in five cohorts. An MTD was not reached. The RP2Ds of clofarabine, cyclophosphamide and etoposide were 40, 440 and 100 mg/m(2)/day, respectively. Complete remission (CR) was achieved in 10 patients (ALL: nine; AML: one), and CR without platelet recovery in six patients (ALL: two; AML: four) for an overall response rate of 64% (ALL: 55%; AML: 100%). Of the 16 responders, 9 patients proceeded to hematopoietic stem cell transplantation. In conclusion, the combination of clofarabine, etoposide and cyclophosphamide was well tolerated and effective in pediatric patients with relapsed/refractory leukemia. Of note, the phase II portion of the trial was amended after the occurrence of unexpected hepatotoxicity. The ongoing phase II study will evaluate the efficacy and safety of this regimen in ALL patients.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Dec
pubmed:issn
1476-5551
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
23
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
2259-64
pubmed:meshHeading
pubmed-meshheading:19741725-Acute Disease, pubmed-meshheading:19741725-Adenine Nucleotides, pubmed-meshheading:19741725-Adolescent, pubmed-meshheading:19741725-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:19741725-Arabinonucleosides, pubmed-meshheading:19741725-Child, pubmed-meshheading:19741725-Child, Preschool, pubmed-meshheading:19741725-Cyclophosphamide, pubmed-meshheading:19741725-Drug-Induced Liver Injury, pubmed-meshheading:19741725-Etoposide, pubmed-meshheading:19741725-Hematopoietic Stem Cell Transplantation, pubmed-meshheading:19741725-Humans, pubmed-meshheading:19741725-Infant, pubmed-meshheading:19741725-Leukemia, pubmed-meshheading:19741725-Leukemia, Myeloid, Acute, pubmed-meshheading:19741725-Maximum Tolerated Dose, pubmed-meshheading:19741725-Precursor Cell Lymphoblastic Leukemia-Lymphoma, pubmed-meshheading:19741725-Remission Induction, pubmed-meshheading:19741725-Salvage Therapy, pubmed-meshheading:19741725-Treatment Outcome, pubmed-meshheading:19741725-Young Adult
pubmed:year
2009
pubmed:articleTitle
A multi-center phase I study of clofarabine, etoposide and cyclophosphamide in combination in pediatric patients with refractory or relapsed acute leukemia.
pubmed:affiliation
Department of Pediatric Hematology-Oncology, Children's Memorial Hospital/Northwestern University Feinberg School of Medicine, 2300 Children's Plaza, Chicago, IL 60614-3394, USA. nhijiya@childrensmemorial.org
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't, Multicenter Study, Clinical Trial, Phase I