drugset / Trial / NCT00477945

Phase I Trial of Clofarabine in Combo w/ HD Etoposide & Cyclophosphamide and APBSCT for Pts w/ High-Risk or Refractory NHL

NCT00477945

NaSingle-groupOpen-labelTreatment

Summary

This is a phase I trial to determine the maximum tolerated dose (MTD) of clofarabine in a combination with high-dose etoposide and cyclophosphamide. This is an initial step in developing a novel myeloablative preparative regimen for autologous hematopoietic stem cell transplantation (ASCT). While this phase I trial will initially develop the regimen in patients with refractory disease, it is expected that it will find its best application in patients with less advanced disease.

Timeline

Start
2007-05
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 30 mg/m2
Subject Clofarabine Other / unclassified 40 mg/m2
Subject Clofarabine Other / unclassified 50 mg/m2
Subject Clofarabine Other / unclassified 60 mg/m2
Subject Clofarabine Other / unclassified 70 mg/m2

Indications