Mobilization by Plerixafor of Haematopoietic Stem Cells in Children (MEP1)

This is a prospective Phase II, monocentre study.

Study Overview

• Status: Completed
• Conditions: Children Cancer, Solid Tumor
• Intervention / Treatment: Drug: Plerixafor, mozobil

Detailed Description

The extensive chemotherapy followed of hematopoietic stem cells reinjection (HSC) is one therapeutic option which the profit is well demonstrated in the treatment of children's solid tumors. It's one of the "standard" treatment of the following tumors: neuroblastoma, metastatic medulloblastoma, Ewing sarcoma, lymphoma in relapse; and because of the big chemosensibility of paediatric cancers, stays an important therapeutic option in the rhabdomyosarcoma in relapse or metastatic, nephroblastoma, etc. The stem cells can be taken in the blood by cytapheresis after mobilization with pharmacologic molecules. At present, the reference of the mobilization treatment is the G-CSF (Granulocyte colony-stimulating factor) in monotherapy during 4 to 6 days. His inconveniences are: lasted of the treatment (4 to 6 days), reproduction of the injections (1 to 2 subcutaneous injections daily), day variability of the peak of mobilization, this hematopoietic stimulation imposes to delay the chemotherapy. The plerixafor activates a massive and fast mobilization of the HSC ( hematopoietic stem cells)(between 6 and 11 hours after the injection). Currently, it's indicated in association with the G-CSF ( Granulocyte colony-stimulating factor)in case of mobilization failure. However, his big flexibility of use could be of a big interest in monotherapy at the child. To date, there is in our knowledge no data on the use of this molecule at the child.

Schema of study: 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(Granulocyte colony-stimulating factor) will be programmed.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 0 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Etienne MERLIN, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: October 20, 2010
• First Posted (Estimate): October 21, 2010

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: children; Plerixafor; Hematopoietic Stem Cell Transplant mobilization
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Plerixafor
• Other Study ID Numbers: CHU-0082