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Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia
Sponsor: University Hospital, Lille
Summary
The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).
Official title: A Phase I Dose Escalation Study of Clofarabine Given in Combination With Multi-agent Therapy for Remission Induction in Pediatric Patients With Acute Lymphoblastic Leukemia in First Relapse or Refractory to First Line Therapy -
Key Details
Gender
All
Age Range
1 Year - 23 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2010-01
Completion Date
2013-06
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
Clofarabine
escalating doses of clofarabine starting from 20 mg/m2/day to 40 mg/m2/day from day 1 to day 5 used in association with etoposide, asparaginase, mitoxantrone and dexamethasone
Locations (2)
Besançon University Hospital
Besançon, France
Lille University Hospital
Lille, France