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

Lymphoma Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

• NCT number: NCT02221492
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Completion date: March 2016