Ignite Creation Date:
2024-05-05 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00695370
Status:
TERMINATED
Last Update Posted:
2008-06-13
First Post:
2008-06-09
Brief Title:
Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Hematopoietic Progenitor Cell Mobilization in Children With Malignancies Evaluation of Pegfilgrastim at 300µgkg in Hematological Steady State
Status:
TERMINATED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruiting or enrolling participants has halted and will not resume
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis pegfilgrastim at 300 µgkg in hematological steady state 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 2 blood volume processed
Design phase 2 study
Judgment criterion percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis less than 2 blood volume processed
Detailed Description:
Patients consecutively referred for HSC mobilization At least 17 days after the previous chemotherapy No hematological growth factor during the 8 previous days
Mobilization one sc injection of 300 µgkg pegfilgrastim Neulasta Amgen
Evaluation during the study CD34 circulating cells from day 2 to day 7 AE recording
Judgment criterion percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis less than 2 blood volume processed
Analysis sequential Bayesian study
Mobilization one sc injection of 300 µgkg pegfilgrastim Neulasta Amgen
Evaluation during the study CD34 circulating cells from day 2 to day 7 AE recording
Judgment criterion percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis less than 2 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