Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299780
Status:
COMPLETED
Last Update Posted:
2007-04-24
First Post:
2006-03-03
Brief Title:
Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase I Study of Parathyroid Hormone in Combination With G-CSF in Patients Requiring Additional Stem Cell Mobilization
Status:
COMPLETED
Status Verified Date:
2007-04
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:
The purpose of this study is to determine the safety of parathyroid hormone in combination with G-CSF when used as a stem cell mobilization regimen for patients who fail to mobilize sufficient progenitor stem cells after one or two attempts
Detailed Description:
Patients will start treatment within 21 days of the determination of inadequate mobilization PTH treatment will be given in 4 cohorts 40 mcg 60 mcg 80 mcg and 10 mcg PTH will be given on day 1 and continue until stem cell collections are complete or a maximum of 20 days G-CSF 10 mcgkg will be given on days 10-14 and continue until stem cell collections are complete Patients with inadequate CD34 cells on Day 14 will meet off study criteria and not continue with PTHG-CSF
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