NCT02221492

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

A Randomized, Open-label, Two-arm Parallel Group, Comparative Study for Assessing the Clinical Benefit of Subcutaneous Injection of Plerixafor Plus G-CSF for Mobilization and Collection of Peripheral Hematopoietic Stem Cells in Japanese Patients With Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Total study duration for a participant can be approximately up to 68 days.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	plerixafor GZ316455	Pharmaceutical form:vial Route of administration: subcutaneous injection
DRUG	Filgrastim	Pharmaceutical form:vial Route of administration: subcutaneous injection

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-08-20
• Last updated: 2016-03-30

Locations

12 sites across 1 country: Japan