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


Phase 2
N/A
18 Years
Not Enrolling
Both
Solid Malignancies

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)

Principal Investigator

Etienne Merlin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Clermont-Ferrand

Authority:

France: Ministry of Health

Study ID:

CHU-0035

NCT ID:

NCT00695370

Start Date:

January 2006

Completion Date:

January 2008

Related Keywords:

  • Solid Malignancies
  • Children
  • cancer
  • Bone marrow transplantation
  • Mobilization
  • G-CSF
  • Children with solid malignancies
  • Neoplasms

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