Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for Poor Stem Cell Mobilization
NCT01037517 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2013-10-31
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
Conditions
Interventions
- DRUG
-
Plerixafor
Plerixafor will be administered at 23:00 of Day -1 to experimental subjects at a dose of 240 mcg/kg subcutaneously, and possibly repeated the following day
- OTHER
-
Observation: Nonintervention
Nonintervention group, no drug will be given, observation only
Sponsors & Collaborators
-
CancerCare Manitoba
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-01-31
- Primary Completion
- 2013-08-31
- Completion
- 2013-08-31
Countries
- Canada
Study Locations
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