NCT00477945

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Non Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	clofarabine	Cohort N Clofarabine (mg/m2/day) 1. 3-6 30 2. 3-6 40 3. 3-6 50 4. 3-6 60 5. 6-10 70

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-05-24
• Last updated: 2014-09-11

Locations

1 site across 1 country: United States