Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children

Solid Malignancies Clinical Trial

Official title:

Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00695370
• Other study ID #: CHU-0035
• Status: Terminated
• Phase: Phase 2
• First received: June 9, 2008
• Last updated: June 12, 2008
• Start date: January 2006
• Est. completion date: January 2008

Study information

• Verified date: June 2008
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Hypothesis: pegfilgrastim at 300 µg/kg 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)

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 µg/kg 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 0 to 18 years

• solid malignancy

• Lansky score >70%

• more than 17 days since the beginning of the last chemotherapy cycle

• absolute neutrophil count (ANC) greater than 1×109/l

• no administration of any hematopoietic growth factor in the previous 8 days

Exclusion Criteria:

• clinical or biological conditions precluding the mobilization or collection procedure

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Solid Malignancies

Intervention

Drug:
• Pegfilgrastim (drug)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
Secondary	Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells