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Trial record 1 of 1 for:    moz11809
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Evaluation of Approved Weight-Based Dose Compared to Fixed Dose of Plerixafor in Patients With Non-Hodgkin's Lymphoma (NHL) Weighing Less Than 70 Kilograms

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ClinicalTrials.gov Identifier: NCT01164475
Recruitment Status : Completed
First Posted : July 16, 2010
Results First Posted : January 31, 2014
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin's Lymphoma
Interventions Drug: Granulocyte-colony stimulating factor (G-CSF)
Drug: Fixed Dose Plerixafor
Drug: Weight-Based Plerixafor
Enrollment 61
Recruitment Details The study was conducted at 7 centers in 4 countries between October 13, 2010 and February 26, 2013.
Pre-assignment Details A total of 71 patients were screened of which 10 patients were screen failures. A total of 61 patients were randomized.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description 10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (greater than or equal to [>=] 5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred. G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Period Title: Overall Study
Started 30 31
Completed 28 29
Not Completed 2 2
Reason Not Completed
Lack of Efficacy             1             0
Other             0             1
Progressive disease             0             1
Protocol Violation             1             0
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor Total
Hide Arm/Group Description 10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred. G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred. Total of all reporting groups
Overall Number of Baseline Participants 30 31 61
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all randomized patients who signed informed consent form and received at least one dose of plerixafor.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 31 participants 61 participants
46.13  (13.40) 47.84  (13.59) 47.00  (13.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Female
18
  60.0%
17
  54.8%
35
  57.4%
Male
12
  40.0%
14
  45.2%
26
  42.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Race: Asian 28 28 56
Race: White 2 3 5
Ethnicity: Hispanic or Latino 1 2 3
Ethnicity: Not Hispanic or Latino 29 29 58
Number of Patients With Peripheral-Blood (PB) Cluster of Differentiation 34+ (CD34+) Cell Count   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Less than 10 cells per microliter (mcL) 20 21 41
Greater than or equal to 10 cells/mcL 10 10 20
[1]
Measure Description: Baseline for this characteristic was “pre G-CSF dose on Day 4”
1.Primary Outcome
Title Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)
Hide Description The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >=5*10^6 CD34+ cells/kg (optimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.
Time Frame Day 5 up to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description:
10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: percentage of participants
60.0 54.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fixed Dose Plerixafor, Weight-Based Plerixafor
Comments The comparison was done using the logistic regression model, adjusted for country and baseline PB CD34+ cell count.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.395
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.91
Confidence Interval (2-Sided) 95%
0.44 to 9.17
Estimation Comments [Not Specified]
2.Primary Outcome
Title Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])
Hide Description [Not Specified]
Time Frame 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description:
10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Overall Number of Participants Analyzed 30 31
Geometric Mean (Standard Error)
Unit of Measure: nanogram*hour per milliliter (ng*hr/mL)
3991.2  (1.03) 2792.7  (1.03)
3.Secondary Outcome
Title Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis
Hide Description The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of >= 2*10^6 CD34+ cells/kg (minimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.
Time Frame Day 5 up to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description:
10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Overall Number of Participants Analyzed 30 31
Measure Type: Number
Unit of Measure: percentage of participants
93.3 90.3
4.Secondary Outcome
Title Median Number of Days of Apheresis to Collect at Least 2*10^6 CD34+ Cells/kg
Hide Description [Not Specified]
Time Frame Day 5 up to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor. Here, number of patients analyzed = the number of patients who were evaluable for this outcome measure.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description:
10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Overall Number of Participants Analyzed 28 28
Median (Full Range)
Unit of Measure: days
1
(1 to 4)
2
(1 to 4)
5.Secondary Outcome
Title Median Number of Days of Apheresis to Collect at Least 5*10^6 CD34+ Cells/kg
Hide Description [Not Specified]
Time Frame Day 5 up to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor. Here, number of patients analyzed = the number of patients who were evaluable for this outcome measure.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description:
10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Overall Number of Participants Analyzed 18 17
Median (Full Range)
Unit of Measure: days
3
(1 to 4)
3
(1 to 4)
6.Secondary Outcome
Title Total Number of CD34+ Cells/kg Collected Over up to 4 Aphereses
Hide Description The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was reported.
Time Frame Day 5 up to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description:
10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Overall Number of Participants Analyzed 30 31
Median (Full Range)
Unit of Measure: 10^6 cells/kg
5.35
(1.2 to 9.6)
5.24
(1.3 to 372.8)
7.Secondary Outcome
Title Mean Fold Increase in Peripheral Blood CD34+ Cell Count Following Plerixafor
Hide Description Fold increase was calculated as CD34+ cell count on Day 5 divided by CD34+ cell count on Day 4.
Time Frame Baseline (pre G-CSF dose on Day 4) to Day 5 (prior to first apheresis)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description:
10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Overall Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: fold increase
5.43  (4.02) 5.09  (2.81)
8.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description:
10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Overall Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: ng/mL
957  (216) 711  (136)
9.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all patients who have signed informed consent and received at least one dose of study drug.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description:
10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Overall Number of Participants Analyzed 30 31
Median (Full Range)
Unit of Measure: hours
0.50
(0.42 to 1.08)
0.50
(0.42 to 1.02)
10.Secondary Outcome
Title Terminal Elimination Half-life (T1/2)
Hide Description T1/2 is the time required for the plasma concentration to decrease to one half.
Time Frame 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description:
10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
Overall Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: hours
4.53  (1.38) 4.27  (0.93)
Time Frame From signing of inform consent form up to 30 days after the last dose of plerixafor
Adverse Event Reporting Description Median number of plerixafor doses was 3 doses for both treatment arms. The analysis was performed on safety population, defined as all patients who signed informed consent form and received at least one dose of plerixafor.
 
Arm/Group Title Fixed Dose Plerixafor Weight-Based Plerixafor
Hide Arm/Group Description 10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred. G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
All-Cause Mortality
Fixed Dose Plerixafor Weight-Based Plerixafor
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Fixed Dose Plerixafor Weight-Based Plerixafor
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   3/31 (9.68%) 
Infections and infestations     
Cellulitis  1  0/30 (0.00%)  1/31 (3.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Diffuse large B-cell lymphoma  1  0/30 (0.00%)  1/31 (3.23%) 
Non-Hodgkin's lymphoma  1  0/30 (0.00%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  0/30 (0.00%)  1/31 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fixed Dose Plerixafor Weight-Based Plerixafor
Affected / at Risk (%) Affected / at Risk (%)
Total   26/30 (86.67%)   25/31 (80.65%) 
Blood and lymphatic system disorders     
Anaemia  1  5/30 (16.67%)  7/31 (22.58%) 
Lymphopenia  1  1/30 (3.33%)  1/31 (3.23%) 
Thrombocytopenia  1  3/30 (10.00%)  5/31 (16.13%) 
Cardiac disorders     
Tachycardia  1  0/30 (0.00%)  1/31 (3.23%) 
Gastrointestinal disorders     
Abdominal discomfort  1  0/30 (0.00%)  2/31 (6.45%) 
Abdominal pain  1  3/30 (10.00%)  1/31 (3.23%) 
Abdominal pain upper  1  2/30 (6.67%)  0/31 (0.00%) 
Constipation  1  1/30 (3.33%)  0/31 (0.00%) 
Diarrhoea  1  8/30 (26.67%)  4/31 (12.90%) 
Dyspepsia  1  1/30 (3.33%)  0/31 (0.00%) 
Flatulence  1  1/30 (3.33%)  0/31 (0.00%) 
Gastrooesophageal reflux disease  1  1/30 (3.33%)  0/31 (0.00%) 
Hypoaesthesia oral  1  1/30 (3.33%)  0/31 (0.00%) 
Nausea  1  4/30 (13.33%)  7/31 (22.58%) 
Paraesthesia oral  1  1/30 (3.33%)  0/31 (0.00%) 
Vomiting  1  2/30 (6.67%)  3/31 (9.68%) 
General disorders     
Asthenia  1  0/30 (0.00%)  2/31 (6.45%) 
Catheter site haemorrhage  1  4/30 (13.33%)  2/31 (6.45%) 
Catheter site pain  1  1/30 (3.33%)  2/31 (6.45%) 
Chest discomfort  1  2/30 (6.67%)  0/31 (0.00%) 
Injection site erythema  1  1/30 (3.33%)  0/31 (0.00%) 
Injection site pruritus  1  0/30 (0.00%)  1/31 (3.23%) 
Non-cardiac chest pain  1  0/30 (0.00%)  1/31 (3.23%) 
Pain  1  3/30 (10.00%)  1/31 (3.23%) 
Puncture site haemorrhage  1  0/30 (0.00%)  1/31 (3.23%) 
Pyrexia  1  0/30 (0.00%)  1/31 (3.23%) 
Infections and infestations     
Sinusitis  1  0/30 (0.00%)  1/31 (3.23%) 
Injury, poisoning and procedural complications     
Contusion  1  0/30 (0.00%)  1/31 (3.23%) 
Scratch  1  1/30 (3.33%)  0/31 (0.00%) 
Wound secretion  1  1/30 (3.33%)  0/31 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  2/30 (6.67%)  1/31 (3.23%) 
Aspartate aminotransferase increased  1  1/30 (3.33%)  2/31 (6.45%) 
Blood albumin decreased  1  1/30 (3.33%)  0/31 (0.00%) 
Blood alkaline phosphatase increased  1  4/30 (13.33%)  2/31 (6.45%) 
Blood calcium decreased  1  0/30 (0.00%)  1/31 (3.23%) 
Blood lactate dehydrogenase increased  1  1/30 (3.33%)  0/31 (0.00%) 
Blood phosphorus increased  1  0/30 (0.00%)  1/31 (3.23%) 
Blood uric acid decreased  1  0/30 (0.00%)  1/31 (3.23%) 
Haematocrit decreased  1  1/30 (3.33%)  3/31 (9.68%) 
Haemoglobin decreased  1  1/30 (3.33%)  0/31 (0.00%) 
International normalised ratio increased  1  2/30 (6.67%)  0/31 (0.00%) 
Lymphocyte count decreased  1  4/30 (13.33%)  3/31 (9.68%) 
Lymphocyte percentage decreased  1  1/30 (3.33%)  0/31 (0.00%) 
Mean cell haemoglobin concentration decreased  1  1/30 (3.33%)  0/31 (0.00%) 
Monocyte count increased  1  2/30 (6.67%)  2/31 (6.45%) 
Neutrophil count increased  1  0/30 (0.00%)  1/31 (3.23%) 
Platelet count decreased  1  14/30 (46.67%)  8/31 (25.81%) 
Protein total  1  1/30 (3.33%)  0/31 (0.00%) 
Protein total decreased  1  1/30 (3.33%)  1/31 (3.23%) 
Red blood cell count decreased  1  2/30 (6.67%)  1/31 (3.23%) 
Red cell distribution width increased  1  1/30 (3.33%)  0/31 (0.00%) 
White blood cell count increased  1  4/30 (13.33%)  4/31 (12.90%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/30 (6.67%)  2/31 (6.45%) 
Fluid overload  1  3/30 (10.00%)  2/31 (6.45%) 
Hypertriglyceridaemia  1  0/30 (0.00%)  1/31 (3.23%) 
Hyperuricaemia  1  1/30 (3.33%)  0/31 (0.00%) 
Hypocalcaemia  1  3/30 (10.00%)  5/31 (16.13%) 
Hypoglycaemia  1  1/30 (3.33%)  0/31 (0.00%) 
Hypokalaemia  1  5/30 (16.67%)  7/31 (22.58%) 
Hypomagnesaemia  1  4/30 (13.33%)  6/31 (19.35%) 
Hypophosphataemia  1  2/30 (6.67%)  4/31 (12.90%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/30 (0.00%)  2/31 (6.45%) 
Bone pain  1  2/30 (6.67%)  0/31 (0.00%) 
Myalgia  1  1/30 (3.33%)  1/31 (3.23%) 
Nervous system disorders     
Anaesthesia  1  1/30 (3.33%)  0/31 (0.00%) 
Dizziness  1  2/30 (6.67%)  2/31 (6.45%) 
Headache  1  1/30 (3.33%)  2/31 (6.45%) 
Hypoaesthesia  1  3/30 (10.00%)  2/31 (6.45%) 
Monoplegia  1  1/30 (3.33%)  0/31 (0.00%) 
Paraesthesia  1  1/30 (3.33%)  0/31 (0.00%) 
Psychiatric disorders     
Anxiety  1  2/30 (6.67%)  0/31 (0.00%) 
Insomnia  1  2/30 (6.67%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  1  1/30 (3.33%)  0/31 (0.00%) 
Dyspnoea  1  1/30 (3.33%)  0/31 (0.00%) 
Oropharyngeal pain  1  1/30 (3.33%)  0/31 (0.00%) 
Throat tightness  1  1/30 (3.33%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders     
Cold sweat  1  1/30 (3.33%)  0/31 (0.00%) 
Erythema  1  0/30 (0.00%)  1/31 (3.23%) 
Night sweats  1  1/30 (3.33%)  0/31 (0.00%) 
Pruritus  1  1/30 (3.33%)  0/31 (0.00%) 
Rash  1  1/30 (3.33%)  0/31 (0.00%) 
Urticaria  1  0/30 (0.00%)  1/31 (3.23%) 
Vascular disorders     
Hypotension  1  0/30 (0.00%)  1/31 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-us@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01164475    
Other Study ID Numbers: MOZ11809
MSC12830 ( Other Identifier: Other Company study code )
First Submitted: July 9, 2010
First Posted: July 16, 2010
Results First Submitted: December 12, 2013
Results First Posted: January 31, 2014
Last Update Posted: February 25, 2014