Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477542
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2007-05-21
Brief Title:
A Phase I Trial of Myeloablative Conditioning w Clofarabine and HD Busulfan for Pts w Refractory Heme Malignancies Undergoing Allo PBSCT
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
A Phase I Trial of Myeloablative Conditioning Using Clofarabine and High-Dose Busulfan for Patients With Refractory Hematological Malignancies Undergoing Allogeneic HSCT
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 trial to determine the maximum tolerated dose MTD of clofarabine in a combination with a myeloablative dose of busulfan This is an initial step in developing a novel myeloablative preparative regimen for allogeneic hematopoietic stem cell transplantation HSCT 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 dose of busulfan 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 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