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Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Granulocyte-colony stimulating factor (G-CSF)
Plerixafor
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring hematopoietic stem cell transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has a biopsy-confirmed diagnosis of NHL
  • Is in first or second complete remission or partial remission, defined for the purpose of this study as complete or partial response following first- or second-line therapy
  • Treatment with an autologous peripheral HSC transplant is planned and the patient is eligible for autologous transplantation
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Has recovered from all acute toxic effects of prior chemotherapy or other cancer treatment.
  • Has an actual body weight <175% of their ideal body weight (IBW)
  • The patient agrees to use a highly effective method of contraception from Day 1 through ≥3 months following plerixafor treatment.

Exclusion Criteria:

  • Concurrent serious illness and pathological conditions
  • Has undergone previous HSC collections or collection attempt
  • Has had any autologous or allogeneic HSC transplant
  • Has active central nervous system (CNS) involvement
  • Bone marrow lymphoma cells involvement >20%, as assessed by bone marrow biopsy within 4 months before signing the ICF
  • Has received radiation therapy to the pelvis
  • Has a diagnosis of all leukemias including any type of CLL
  • Active infection
  • Pregnant or nursing
  • Anticipated post-transplant chemotherapy and/or radiation therapy below the diaphragm
  • Received any prior radio-immunotherapy
  • Prior 1,3-bis(2-chloroethyl)-1-nitroso-urea (BCNU) within 6 weeks prior to first dose of G-CSF
  • Prior cancer therapy, other investigational therapy within 4 weeks prior to first dose of G-CSF
  • Prior granulocyte/macrophage-colony stimulating factor (GM-CSF) or pegfilgrastim within 3 weeks prior to the first dose of G-CSF
  • Prior G-CSF within 2 weeks prior to the first dose of G-CSF
  • Inadequate organ funtion evidenced by unacceptable laboratory result

Sites / Locations

  • Investigational Site Number 156017
  • Investigational Site Number 156001
  • Investigational Site Number 156005
  • Investigational Site Number 156002
  • Investigational Site Number 156003
  • Investigational Site Number 156020
  • Investigational Site Number 156016
  • Investigational Site Number 156021
  • Investigational Site Number 156011
  • Investigational Site Number 156018
  • Investigational Site Number 156009
  • Investigational Site Number 156010
  • Investigational Site Number 156008
  • Investigational Site Number 156013
  • Investigational Site Number 156015
  • Investigational Site Number 156022

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

G-CSF + plerixafor

G-CSF + Placebo

Arm Description

Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive plerixafor in the evening up to a maximum of 4 doses.

Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive placebo in the evening up to a maximum of 4 doses.

Outcomes

Primary Outcome Measures

Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis

Secondary Outcome Measures

Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis
Number of days of apheresis to collect ≥2 × 10^6 CD34+ cells/kg
Number of days of apheresis to collect ≥5 × 10^6 CD34+ cells/kg
Total number of CD34+ cells collected
Time from transplantation to neutrophil and platelet (PLT) engraftment
Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Maximum plasma concentration (Cmax)
Time to reach Cmax (Tmax)
Area Under the Curve 0 to 10 hours post-dose (AUC0-10)
Area Under the Curve 0 to last observed concentration (AUClast)
Area Under the Curve (AUC)
Percentage of extrapolation of AUC (AUCext)
Half life (T1/2)
Volume of distribution (Vz/F)
Total body clearance (CL/F)
Peripheral blood CD34+ cell counts (Pharmacodynamic analysis)
The fold-increase in the number of circulating CD34+ following the first dose of plerixafor or placebo, with the first apheresis day (Day 5) value serving as the primary estimate

Full Information

First Posted
December 17, 2012
Last Updated
December 8, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01767714
Brief Title
Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
Official Title
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of Plerixafor (0.24 mg/kg) Plus G CSF (10 µg/kg) Versus G CSF (10 µg/kg) Plus Placebo to Mobilize and Collect ≥5 × 106 CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day [GRAN® only]) plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus placebo.
Detailed Description
Eligible patients who are unable to achieve adequate apheresis cell counts may enter an Open-Label Rescue Period where they will receive plerixafor, following the same study schedule as during the Double-Blind Treatment Period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
hematopoietic stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G-CSF + plerixafor
Arm Type
Experimental
Arm Description
Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive plerixafor in the evening up to a maximum of 4 doses.
Arm Title
G-CSF + Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive placebo in the evening up to a maximum of 4 doses.
Intervention Type
Drug
Intervention Name(s)
Granulocyte-colony stimulating factor (G-CSF)
Other Intervention Name(s)
GRAN®, Filgrastim
Intervention Description
10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Plerixafor
Other Intervention Name(s)
Mozobil, AMD3100, GZ316455
Intervention Description
0.24 mg/kg/day subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis
Time Frame
Days 5- Day8
Secondary Outcome Measure Information:
Title
Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis
Time Frame
Day 5 - Day 8
Title
Number of days of apheresis to collect ≥2 × 10^6 CD34+ cells/kg
Time Frame
Up to achieve the target of collecting ≥2 × 10^6 CD34+ cells/kg
Title
Number of days of apheresis to collect ≥5 × 10^6 CD34+ cells/kg
Time Frame
Up to achieve the target of collecting ≥5 × 10^6 CD34+ cells/kg
Title
Total number of CD34+ cells collected
Time Frame
Day 5 - Day 8
Title
Time from transplantation to neutrophil and platelet (PLT) engraftment
Time Frame
up to 30 days post-transplantation
Title
Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame
from signed Informed Consent Form (ICF) to 30 days post-transplant and then ongoing as needed
Title
Maximum plasma concentration (Cmax)
Time Frame
Day 4 - Day 5
Title
Time to reach Cmax (Tmax)
Time Frame
Day 4 - Day 5
Title
Area Under the Curve 0 to 10 hours post-dose (AUC0-10)
Time Frame
Day 4 - Day 5
Title
Area Under the Curve 0 to last observed concentration (AUClast)
Time Frame
Day 4 - Day 5
Title
Area Under the Curve (AUC)
Time Frame
Day 4 - Day 5
Title
Percentage of extrapolation of AUC (AUCext)
Time Frame
Day 4 - Day 5
Title
Half life (T1/2)
Time Frame
Day 4 - Day 5
Title
Volume of distribution (Vz/F)
Time Frame
Day 4 - Day 5
Title
Total body clearance (CL/F)
Time Frame
Day 4 - Day 5
Title
Peripheral blood CD34+ cell counts (Pharmacodynamic analysis)
Time Frame
Day 4 - Day 5
Title
The fold-increase in the number of circulating CD34+ following the first dose of plerixafor or placebo, with the first apheresis day (Day 5) value serving as the primary estimate
Time Frame
Day 5 - Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a biopsy-confirmed diagnosis of NHL Is in first or second complete remission or partial remission, defined for the purpose of this study as complete or partial response following first- or second-line therapy Treatment with an autologous peripheral HSC transplant is planned and the patient is eligible for autologous transplantation Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Has recovered from all acute toxic effects of prior chemotherapy or other cancer treatment. Has an actual body weight <175% of their ideal body weight (IBW) The patient agrees to use a highly effective method of contraception from Day 1 through ≥3 months following plerixafor treatment. Exclusion Criteria: Concurrent serious illness and pathological conditions Has undergone previous HSC collections or collection attempt Has had any autologous or allogeneic HSC transplant Has active central nervous system (CNS) involvement Bone marrow lymphoma cells involvement >20%, as assessed by bone marrow biopsy within 4 months before signing the ICF Has received radiation therapy to the pelvis Has a diagnosis of all leukemias including any type of CLL Active infection Pregnant or nursing Anticipated post-transplant chemotherapy and/or radiation therapy below the diaphragm Received any prior radio-immunotherapy Prior 1,3-bis(2-chloroethyl)-1-nitroso-urea (BCNU) within 6 weeks prior to first dose of G-CSF Prior cancer therapy, other investigational therapy within 4 weeks prior to first dose of G-CSF Prior granulocyte/macrophage-colony stimulating factor (GM-CSF) or pegfilgrastim within 3 weeks prior to the first dose of G-CSF Prior G-CSF within 2 weeks prior to the first dose of G-CSF Inadequate organ funtion evidenced by unacceptable laboratory result
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 156017
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Investigational Site Number 156001
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Investigational Site Number 156005
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Investigational Site Number 156002
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Investigational Site Number 156003
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Investigational Site Number 156020
City
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Investigational Site Number 156016
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Investigational Site Number 156021
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Investigational Site Number 156011
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Investigational Site Number 156018
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Investigational Site Number 156009
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Investigational Site Number 156010
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
Investigational Site Number 156008
City
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Investigational Site Number 156013
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Investigational Site Number 156015
City
Xi'An
ZIP/Postal Code
710038
Country
China
Facility Name
Investigational Site Number 156022
City
Zhengzhou
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation

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