Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477945
Status:
COMPLETED
Last Update Posted:
2014-09-11
First Post:
2007-05-22
Brief Title:
Phase I Trial of Clofarabine in Combo w HD Etoposide Cyclophosphamide and APBSCT for Pts w High-Risk or Refractory NHL
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
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-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 55 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None