NCT01385891

Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children

Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Istituto Giannina Gaslini · Academic / Other
• Sex: All
• Age: 1 Month – 20 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Acute Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-12-01
• Completion: 2010-02-01
• First posted: 2011-06-30
• Last updated: 2011-07-08

Locations

1 site across 1 country: Italy