Mobilization by Plerixafor of Haematopoietic Stem Cells in Children

NCT01225419 | Completed Phase 2

• 1 other identifier: CHU-0082
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective Phase II, monocentre study.

Conditions

Children Cancer, Solid Tumor

Keywords

Plerixafor; Hematopoietic Stem Cell Transplant mobilization; children

Outcome Measures

Primary Outcomes (1)

• Percentage of the children to whom 5.106 cells CD34 + / kg can be collected in 2 masses blood treated (one cytapheresis).

  between H4 and H9 at day 0

Secondary Outcomes (5)

• Describe the kinetics of mobilization of the hematopoietic progenitor at the child in situation of hematopoietic stable state after a subcutaneous injection of plerixafor

  between the injection and the apheresis at day 0

• Describe the pharmacokinetics of the plerixafor at the child

  between the injection and the apheresis at day 0

• Describe the side effects

  day 0 to day 3

• Describe the capacity of hematopoietic reconstruction of taken cells after mobilization by plerixafor only

  during the 30 following days

• the toxicity of the plerixafor at the child.

  day 0 to day 3

Interventions

Plerixafor, mozobil DRUG

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 18 years old
• Solid malign tumor
• Lansky score ≥ 70%
• Indication of hematopoietic stem cell taking by cytapheresis for extensive chemotherapy followed by one or several reinjections of hematopoietic stem cells

You may not qualify if:

• Administration of hematopoietic growth factors in 8 days preceding the injection of Plerixafor.
• Contraindication in the cytapheresis or in the extensive chemotherapy.
• Clinical or biological state dissuading the realization of the cytapheresis
• Chemotherapy in 15 days preceding the injection of plerixafor or neutrophils \< 1500/mm3

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

plerixafor

Study Officials

• Etienne MERLIN

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 21, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

FR (1)