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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00695370
Other study ID # CHU-0035
Secondary ID
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


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
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