Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin Lymphoma

• Status: Completed
• Trial end date: 2016-03-01

Summary

Primary Objective:

To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 5 x 10^6 cluster differential (CD) 34+ cells/kg in 4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone.

Secondary Objectives:

• To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL participants.

• To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.

• To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 5 x 10^6 CD34+ cells/kg.

• Phase: Phase 2

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: JM 3100; Lenograstim; Plerixafor