Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia

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).

Conditions

• Acute Lymphoid Leukemia Relapse
• Acute Lymphoid Leukemia Relapse After Bone Marrow Transplant

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• Saint-Louis Hospital, Paris, France

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• University Hospital, Marseille

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• University Hospital, Lille

  lead OTHER

Principal Investigators

• Brigitte Nelken, MD PhD · Lille Unıversity Hospital, Lille, France

• Pıerre S Rohrlich, MD, PhD · Besancon University Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

23 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2012-06-30

Completion

2013-06-30

Countries

• France

Study Locations