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Mobilization by Plerixafor of Haematopoietic Stem Cells in Children

NCT01225419 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-07-08

No results posted yet for this study

Summary

This is a prospective Phase II, monocentre study.

Conditions

  • Children Cancer, Solid Tumor

Interventions

DRUG

Plerixafor, mozobil

Subcutaneous injection of 240 µg/kg of Plerixafor (Mozobil ®, Genzyme) at 8 am the day of the cytapheresis. Determination of CD34+ cells circulating in h0 then every hour of h3 to h11. Taking by cytapheresis from the 5th hour of the injection if the rate of CD34+ is upper or equal in 10.106/l. If the rate of CD34+ in the blood does not reach 10.106/l after the first injection of plerixafor or if the first cytapheresis does not allow the collection of at least 5.106/kg CD34+ cells, the patient will be considered in failure and a conventional mobilization by G-CSF will be programmed

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Etienne MERLIN · University Hospital, Clermont-Ferrand

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225419 on ClinicalTrials.gov