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Plerixafor as a Salvage Regimen to Mobilize Allogeneic Stem Cells in Healthy Volunteers

NCT01954914 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-09-19

No results posted yet for this study

Summary

With a standard mobilization regimen using G-CSF, approximately 5% of allogeneic donors does not mobilize enough CD34+ cells to reach an optimal dose for transplantation and are therefore called "poor mobilizers". A generally accepted optimum CD34+ PBSC dose for allogeneic transplantation is \> 4.5 x 106/kg body weight of the recipient. The minimum total CD34+ PBSC dose certainly amounts to 2 x 106/kg body weight of the recipient.The objective of this trial is to assess the efficacy of a single dose of Plerixafor as salvage procedure in allogeneic stem cell donors with a poor CD34+ cell yield after the first day of peripheral blood stem cell collection.

Conditions

  • Blood Stem Cell Harvest Failure

Interventions

DRUG

Plerixafor

Administration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1.

Sponsors & Collaborators

  • University Hospital Carl Gustav Carus

    collaborator OTHER

  • Cellex Gesellschaft für Zellgewinnung mbH Dresden

    collaborator UNKNOWN

  • Cellex Gesellschaft für Zellgewinnung mbH Köln

    collaborator UNKNOWN

  • Technische Universität Dresden

    lead OTHER

Principal Investigators

  • Kristina Hölig, Dr. med. · Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Germany

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 NCT01954914 on ClinicalTrials.gov