A Phase 2/3 interventional study of Clofarabine VP 16 ciclophospahamide in Acute Leukemia, sponsored by Istituto Giannina Gaslini. Completed at 1 site in Italy. Open to participants aged 1 Month to 20 Years. Per ClinicalTrials.gov, last updated 2011-07-08.
Sponsored by Istituto Giannina Gaslini · Phase 2/3, Interventional, and Treatment
Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric.
Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 40 is close to the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Istituto Giannina Gaslini is the lead sponsor of 32 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Clofarabine VP 16 ciclophospahamide
Clofarabine intravenously 2-hour infusion,dose 40 mg/m2, followed by Etoposide (VP 16)100 mg/m2 i.v. over 2 hours and Cyclophosphamide 440 mg/m2 i.v. over 1 hour
Also known as: Evoltra, Etoposide, Endoxan
response to treatment
Time frame: after an expected average of 3 weeks after the first dose of each chemotherapy course
Number of patients with toxicity as a measure of safety and tolerability
Grade of toxicity defined according to the National Cancer's Inst. Common terminology Criteria (NCI CTCAE v3.0)
Time frame: at an expected average of 4 weeks after the first dose of each chemotherapy course
This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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Istituto Giannina Gaslini