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COMPLETED
NCT01279096
PHASE1

Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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

Interventions

DRUG

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