Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234169
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2005-10-04
Brief Title:
A Study of Peripheral Blood Progenitor Cells Mobilisation PBPC With VTP195183 Plus Granulocyte-Colony Stimulating Factor G-CSF Compared to Mobilisation With G-CSF Alone
Sponsor:
Peter MacCallum Cancer Centre Australia
Organization:
Peter MacCallum Cancer Centre Australia
Study Overview
Official Title:
A Phase III Study of Peripheral Blood Progenitor Cells Mobilisation With VTP195183 Plus G-CSF Compared to Mobilisation With G-CSF Alone in Patients With Multiple Myeloma and Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-05
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:
Hematopoietic stem cells HSC are used to support the administration of high dose chemotherapy for a range of human cancers For a safe HSC transplantation a minimum of 5 million HSC per kilogram are required HSC are collected from the bone marrow by using drugs such as G-CSF filgrastim which mobilize them from the bone marrow into the bloodstream HSC are collected from the bloodstream using an apheresis machine Between 5 and 60 of patients fail to mobilize the minimum HSC dose required for safe transplantation and this trial is investigating a way to enhance mobilization to overcome this problem This trial aims to determine if a new vitamin A derivative is capable of enhancing HSC mobilization when used in conjunction with G-CSF Patients will undergo two mobilization procedures They will be given G-CSF alone or a combination of the study drug plus G-CSF and their stem cells will be collected A comparison group of patients will be given G-CSF alone for both mobilizations Stem cells collected from patients in this trial will be frozen and stored until they are required for transplantation into that patient At that time patients will be monitored for how well they recover from their high dose chemotherapy and HSC transplantation
Detailed Description:
None
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