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Clinical Trials/NCT01037517
NCT01037517CompletedPhase 2

Open Label Phase II Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization

CancerCare Manitoba1 site in 1 country52 target enrollmentStarted: January 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
52
Locations
1
Primary Endpoint
To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Poor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection.

OBJECTIVES

To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will:

  • increase the number of patients successfully collected in one day
  • increase the number of patients successfully mobilized on first collection attempt
  • is cost neutral within a Canadian setting

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Participants must be 18 years of age or older
  • •Patients must be able to provide written consent
  • •Participants must have a diagnosis of lymphoma or multiple myeloma and be undergoing autologous stem cell mobilization for the purposes of ASCT
  • •Females of child bearing age will be asked to use an approved form of contraception

Exclusion Criteria

  • •Patients who are pregnant or breastfeeding
  • •Patients whose creatinine ≥ 250 μM
  • •Serum AST, ALT or total bilirubin >5X upper limit of normal
  • •Acute infection

Arms & Interventions

Poor Mobilizers

Experimental

Poor Mobilizer are defined as patients who on Day -1 have a peripheral blood [CD34] ≤ 10 X106/L

Intervention: Plerixafor (Drug)

Outcomes

Primary Outcomes

To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected in one day. The anticipated proportion increase is from 30%-60%.

Time Frame: within 1-2 days after commencing therapy

Secondary Outcomes

  • To examine the immune recovery at day 100 post ASCT in those treated and not treated with plerixafor(After therapy)
  • To undertake a pharmacoeconomic evaluation to examine the impact of plerixafor on resource utilization in a population at risk for poor mobilization(After therapy)
  • To increase the proportion of Poor Mobilizers who after receiving plerixafor are successfully collected on first mobilization attempt rather than requiring a second mobilization.(After therapy)
  • To describe the kinetics of platelet and neutrophil recovery post ASCT in those treated and not treated with plerixafor(After therapy)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. David Szwajcer

Hematologist/Oncologist

CancerCare Manitoba

Study Sites (1)

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