A Phase I Trial of Clofarabine in Combination With High-Dose Etoposide and Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation for Patients With High-Risk or Refractory Non-Hodgkin's Lymphoma
All patients will receive the same doses of etoposide and cyclophosphamide. The dose of
clofarabine will be escalated in successive cohorts of patients. Using a standard dose
escalation design, successive cohorts of 3 patients will be treated with escalating doses of
clofarabine (see Section 5.5 below). At the MTD (or highest dose-level if the MTD is not
reached), the cohort will be expanded to 10 patients to better investigate correlative
studies and give some preliminary idea of efficacy.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose (MTD) of clofarabine in association with high-dose etoposide and cyclophosphamide followed by ASCT in patients with refractory lymphoma malignancies.
1 yr
Yes
Sherif Farag, MD, PhD
Principal Investigator
Indiana University
United States: Institutional Review Board
0704-29 IUCRO-0187
NCT00477945
May 2007
November 2010
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |