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Plerixafor vs Plerixafor + G-CSF for Stem Cell Mobilization in Healthy Donors
NCT01403896Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2012
- Primary completion
- Dec 2015
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- plerixafor
- Conditions
- hematopoietic stem cell mobilization
01
Overview
Phase 2, randomised, open-label trial of plerixafor in hematopoietic stem cell mobilization (2 arms). Primary endpoints: Frequency of CD34+ cells and Frequency of CD34+CD38- cells. Started Apr 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Plerixafor Group
Plerixafor alone
Plerixafor + G-CSF Group
Plerixafor combined with G-CSF
03
Who it enrols
Healthy male or female donors aged 18-30 with no history of cardiac, pulmonary, liver, or renal disease, and normal lab values. Excludes BMI > 25, pregnancy, and specific allergies or conditions.
04
Endpoints
Primary
Frequency of CD34+ cells
Frequency of CD34+CD38- cells
Secondary
Frequency of CD56bright NK cells
Frequency of CD4+ central memory T-cells
Frequency of perforin+ CD8+ T-cells
Frequency of CD19+ CD27-TLR9+ B-cells
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