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.
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.
Sherif Farag, MD, PhD
United States: Institutional Review Board
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