Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5) - Full Text View

Sponsors and Collaborators:	University Hospital, Clermont-Ferrand Amgen
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00751894

Purpose

Hypothesis : pegfilgrastim at 200 µg/kg 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

Condition	Intervention	Phase
Solid Malignancies	Drug: Pegfilgrastim (Neulasta, Amgen)	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Granulocyte colony-stimulating factor Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Official Title:	Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) [ Time Frame: less than 3 blood volume processed ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells [ Time Frame: at least 5*10e6CD34cells ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

sequential Bayesian study

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 µg/kg 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

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

0 to 18 years
solid malignancy
Lansky score >70%
12 to 18 days since the beginning of the last chemotherapy cycle
no administration of any hematopoietic growth factor in the previous 8 days

Exclusion Criteria:

clinical or biological conditions precluding the mobilization or collection procedure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751894

Contacts

Contact: Patrick Lacarin

04.73.75.11.95

placarin@chu-clermontferrand.fr

Locations

France
CHU
Clermont-Ferrand, France, 63058

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Amgen

Investigators

Principal Investigator:

Etienne Merlin, DR

University Hospital, Clermont-Ferrand

More Information

Responsible Party:	CHU Clermont-Ferrand ( Dr Etienne MERLIN )
Study ID Numbers:	CHU-0041
Study First Received:	September 11, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00751894
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Children
cancer
Bone marrow transplantation

Stem cell mobilization
G-CSF
Children with solid malignancies

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009