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).

Timeline

Start

2010-01

Primary completion

2012-06

Completion

2013-06

Publications

• Results Nelken B, Cave H, Leverger G, Galambrun C, Plat G, Schmitt C, Thomas C, Verite C, Brethon B, Gandemer V, Bertrand Y, Baruchel A, Rohrlich P. A Phase I Study of Clofarabine With Multiagent Chemotherapy in Childhood High Risk Relapse of Acute Lymphoblastic Leukemia (VANDEVOL Study of the French SFCE Acute Leukemia Committee). Pediatr Blood Cancer. 2016 Feb;63(2):270-5. doi: 10.1002/pbc.25751. Epub 2015 Sep 16.

Drugs

Indications