Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-01-31

Brief Summary

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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)

Detailed Description

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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

Conditions

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Solid Malignancies

Keywords

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Children cancer Bone marrow transplantation Mobilization G-CSF Children with solid malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pegfilgrastim (drug)

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Etienne Merlin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Other Identifiers

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CHU-0035

Identifier Type: -

Identifier Source: org_study_id