Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin Lymphoma
- Registration Number
- NCT02221492
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description granulocyte colony-stimulating factor plus plerixafor plerixafor GZ316455 G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7) granulocyte colony-stimulating factor alone Filgrastim G-CSF administered up to 8 days granulocyte colony-stimulating factor plus plerixafor Filgrastim G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7)
- Primary Outcome Measures
Name Time Method Proportion of participants who achieve a collection of greater than or equal to 5 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis Day 5 to Day 8 of the apheresis/treatment period
- Secondary Outcome Measures
Name Time Method Number of days of apheresis to collect 5 x10^6 cells/kg CD34+ cells Day 5 to Day 8 of the apheresis/treatment period Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells Day 5 to Day 8 of the apheresis/treatment period The relative increase (ratio) of peripheral blood (PB) CD34+ cell count (cells/μL) From Day 4 morning to Day 5 morning for both arms, from Day 4 morning to Day 4 evening for GP arm only, and from Day 4 evening to Day 5 morning for GP arm only Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis Day 5 to Day 8 of the apheresis/treatment period Total number of CD34+ cells/kg collected over up to 4 apheresis Day 5 to Day 8 of the apheresis/treatment period Number of participants with adverse events Up to 68 days Change from baseline in clinical laboratory measurements Up to 68 days
Trial Locations
- Locations (12)
Investigational Site Number 392005
🇯🇵Chiba-Shi, Japan
Investigational Site Number 392010
🇯🇵Hamamatsu-Shi, Japan
Investigational Site Number 392003
🇯🇵Kobe-Shi, Japan
Investigational Site Number 392007
🇯🇵Toyohashi-Shi, Japan
Investigational Site Number 392009
🇯🇵Suwa-Shi, Japan
Investigational Site Number 392004
🇯🇵Sapporo-Shi, Japan
Investigational Site Number 392011
🇯🇵Fukuoka-Shi, Japan
Investigational Site Number 392014
🇯🇵Fukuyama-Shi, Japan
Investigational Site Number 392006
🇯🇵Kamogawa-Shi, Japan
Investigational Site Number 392008
🇯🇵Kurashiki-Shi, Japan
Investigational Site Number 392015
🇯🇵Ota-Shi, Japan
Investigational Site Number 392001
🇯🇵Shibuya-Ku, Japan