drugset / Trial / NCT01385891

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

NCT01385891

Phase 2/3 Completed 40 enrolled Gaslini Institute
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2008-08
Primary completion
2009-12
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 40 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 440 mg/m2 Intravenous
Subject Etoposide Small molecule 100 mg/m2 Intravenous

Indications