Ignite Creation Date:
2024-05-05 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00751894
Status:
UNKNOWN
Last Update Posted:
2011-01-19
First Post:
2008-09-11
Brief Title:
Pegfilgrastim for Stem Cell Mobilization in Children Meg-5
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Haematopoietic Progenitor Cell Mobilization in Children With Malignancies Evaluation of Pegfilgrastim at 200µgkg After Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
NOT_YET_RECRUITING
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:
MEG-5
Brief Summary:
Hypothesis pegfilgrastim at 200 µgkg between 12 and 18 days after previous chemotherapy provides an efficient stem cell mobilization in children with malignancies Design phase 2 study Judgment criterion percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis less than 3 blood volume processed
Detailed Description:
Patients consecutively referred for HSC mobilization 12 to 18 days after the previous chemotherapy No haematological growth factor during the 8 previous days
Mobilization one sc injection of 200 µgkg pegfilgrastim Neulasta Amgen Evaluation during the study CD34 circulating cells from day 3 to day 7 AE recording Judgment criterion percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis less than 3 blood volume processed Analysis sequential Bayesian study
Mobilization one sc injection of 200 µgkg pegfilgrastim Neulasta Amgen Evaluation during the study CD34 circulating cells from day 3 to day 7 AE recording Judgment criterion percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis less than 3 blood volume processed Analysis sequential Bayesian study
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