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

NCT01385891 Phase 2/Phase 3 COMPLETED

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

Details

Lead sponsor	Istituto Giannina Gaslini
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	40
Start date	2008-08
Completion	2010-02

Conditions

• Acute Leukemia

Interventions

• Clofarabine VP 16 ciclophospahamide

Primary outcomes

• response to treatment — after an expected average of 3 weeks after the first dose of each chemotherapy course

Countries

Italy