Evaluation of Approved Weight-Based Dose Compared to Fixe... | NCT01164475

NCT01164475

ID	Type	Description	Link
MSC12830	Other Identifier	Other Company study code

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fixed Dose Plerixafor	Experimental	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.	Drug: Granulocyte-colony stimulating factor (G-CSF) Drug: Fixed Dose Plerixafor
Weight-Based Plerixafor	Active Comparator	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.	Drug: Granulocyte-colony stimulating factor (G-CSF) Drug: Weight-Based Plerixafor

Name	Type	Description	Arm Group Labels	Other Names
Granulocyte-colony stimulating factor (G-CSF)	Drug		Fixed Dose Plerixafor Weight-Based Plerixafor	Filgrastim

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)	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.	Day 5 up to Day 8
Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])		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

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 to 78 years (inclusive)
Patients diagnosed with NHL who were to receive treatment with an autologous peripheral stem cell transplant for the first time
Biopsy-confirmed diagnosis of NHL (chronic lymphocytic leukemia and all variants were excluded)
Weight less than or equal to 70 kg
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 only
At least 4 weeks since last cycle of chemotherapy and/or other cancer therapy including rituximab
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Recovered from all acute toxic effects of prior chemotherapy
Negative for human immunodeficiency virus (HIV), active hepatitis B, and active hepatitis C from assessments performed within 3 months before signing informed consent
Signed informed consent form (ICF)
White blood cell count (WBC) greater than (>) 2.5*10^9 per liter (L)
Absolute neutrophil count (ANC) >1.5*10^9/L
Platelet (PLT) count >100*10^9/L
Creatinine clearance >=80 milliliter per minute (mL/min) (estimated by Cockcroft-Gault formula or 24 hour urine collection)
Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST), serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT), and total bilirubin less than 2.5*upper limit of normal
Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
All patients agreed to an effective method of contraception while on study treatment and for at least 3 months following plerixafor treatment (including both female patients of child-bearing potential and male patients with partners of child-bearing potential)

Exclusion Criteria:

A co-morbid condition which, in the view of the Investigator(s), rendered the patient at high risk from treatment complications
Failed previous hematopoietic stem cell (HSC) collections or collection attempts
Prior autologous or allogeneic transplant
Less than 6 weeks off 1,3-bis (2-chloroethyl)-1-nitroso-urea (BCNU) prior to first dose of G-CSF
Active central nervous system involvement, active brain metastases, or any history of carcinomatous meningitis (active or inactive)
Bone marrow involvement >20 percent (%), as assessed by bone marrow biopsy within 4 months of the first screening assessment, unless a bone marrow biopsy was performed immediately prior to the last chemotherapy and was negative and the patient responded to last chemotherapy achieving a complete or partial remission
Received radiation therapy to the pelvis
Received granulocyte/macrophage-colony stimulating factor (GM-CSF) or pegfilgrastim within 3 weeks prior to the first dose of granulocyte colony stimulating factor (G-CSF) for mobilization
Received G-CSF within 14 days prior to the first dose of G-CSF for mobilization
Received prior radio-immunotherapy with ibritumomab tiuxetan or tositumomab iodine
Active infection, including unexplained fever (>38.1 degree Celsius / 100.4 Fahrenheit), or antibiotic, antiviral, or antifungal therapy within 7 days prior to the first dose of G-CSF
Positive pregnancy test (female patients)
Lactating (female patients)
Abnormal electrocardiogram (ECG) with clinically significant rhythm disturbance (ventricular arrhythmias) or other conduction abnormality in the last year that, in the opinion of the Investigator(s), warranted exclusion of the patient from the trial
Previously received experimental therapy within 4 weeks of enrolling or who were currently enrolled in another experimental protocol during the G CSF and plerixafor treatment period

Contacts/Locations Module

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope National Medical Center		Duarte	California	91010	United States
University of Colorado Cancer Center

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Fixed Dose Plerixafor	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Full analysis set (FAS) included all randomized patients who signed informed consent form and received at least one dose of plerixafor.

Arm/Group Information

ID	Title	Description
BG000	Fixed Dose Plerixafor	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.
BG001	Weight-Based Plerixafor	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00030 BG00131 BG00261

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00046.13± 13.40 BG00147.84± 13.59 BG00247.00± 13.41

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00018 BG00117 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Race: Asian

Title	Measurements
	BG00028 BG00128 BG002

Number of Patients With Peripheral-Blood (PB) Cluster of Differentiation 34+ (CD34+) Cell Count

Baseline for this characteristic was "pre G-CSF dose on Day 4"

Number

participants

Title

Denominators

Categories

Less than 10 cells per microliter (mcL)

Title	Measurements
	BG00020 BG00121

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)

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.

FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.

Posted

Number

percentage of participants

Day 5 up to Day 8

ID	Title	Description
OG000	Fixed Dose Plerixafor	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.
OG001	Weight-Based Plerixafor	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.

Units	Counts
Participants	OG00030 OG00131

Title

Denominators

Categories

Title	Measurements
	OG00060.0 OG00154.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The comparison was done using the logistic regression model, adjusted for country and baseline PB CD34+ cell count.	Regression, Logistic		0.395		Odds Ratio (OR)	1.91			2-Sided	95	0.44	9.17				No	Superiority or Other

Primary

Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])

FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.

Posted

Geometric Mean

Standard Error

nanogram*hour per milliliter (ng*hr/mL)

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

ID	Title	Description
OG000	Fixed Dose Plerixafor	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.
OG001	Weight-Based Plerixafor	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.

Secondary

Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis

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.

FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.

Posted

Number

percentage of participants

Day 5 up to Day 8

ID	Title	Description
OG000	Fixed Dose Plerixafor	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.
OG001	Weight-Based Plerixafor

Secondary

Median Number of Days of Apheresis to Collect at Least 2*10^6 CD34+ Cells/kg

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.

Posted

Median

Full Range

days

Day 5 up to Day 8

ID	Title	Description
OG000	Fixed Dose Plerixafor	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.
OG001	Weight-Based Plerixafor	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.

Secondary

Median Number of Days of Apheresis to Collect at Least 5*10^6 CD34+ Cells/kg

Posted

Median

Full Range

days

Day 5 up to Day 8

ID	Title	Description
OG000	Fixed Dose Plerixafor	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.
OG001	Weight-Based Plerixafor	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.

Secondary

Total Number of CD34+ Cells/kg Collected Over up to 4 Aphereses

The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was reported.

FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.

Posted

Median

Full Range

10^6 cells/kg

Day 5 up to Day 8

ID	Title	Description
OG000	Fixed Dose Plerixafor	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.
OG001	Weight-Based Plerixafor	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.

Secondary

Mean Fold Increase in Peripheral Blood CD34+ Cell Count Following Plerixafor

Fold increase was calculated as CD34+ cell count on Day 5 divided by CD34+ cell count on Day 4.

FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.

Posted

Mean

Standard Deviation

fold increase

Baseline (pre G-CSF dose on Day 4) to Day 5 (prior to first apheresis)

ID	Title	Description
OG000	Fixed Dose Plerixafor	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.
OG001	Weight-Based Plerixafor	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.

Secondary

Maximum Observed Plasma Concentration (Cmax)

FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.

Posted

Mean

Standard Deviation

ng/mL

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

ID	Title	Description
OG000	Fixed Dose Plerixafor	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.
OG001	Weight-Based Plerixafor	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.

Secondary

Time to Reach Maximum Plasma Concentration (Tmax)

FAS included all patients who have signed informed consent and received at least one dose of study drug.

Posted

Median

Full Range

hours

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

ID	Title	Description
OG000	Fixed Dose Plerixafor	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.
OG001	Weight-Based Plerixafor	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.

Secondary

Terminal Elimination Half-life (T1/2)

T1/2 is the time required for the plasma concentration to decrease to one half.

FAS included all randomized patients who signed informed consent form and received at least one dose of plerixafor.

Posted

Mean

Standard Deviation

hours

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

ID	Title	Description
OG000	Fixed Dose Plerixafor	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.
OG001	Weight-Based Plerixafor	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fixed Dose Plerixafor	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.			0	30	26	30
EG001	Weight-Based Plerixafor	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.			3	31	25	31

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected30 at risk EG0017 affected31 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0011 affected31 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected30 at risk EG0015 affected31 at risk
Tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0012 affected31 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected30 at risk EG0011 affected31 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0010 affected31 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0008 affected30 at risk EG0014 affected31 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Flatulence	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected30 at risk EG0017 affected31 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0013 affected31 at risk
Asthenia	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0012 affected31 at risk
Catheter site haemorrhage	General disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected30 at risk EG0012 affected31 at risk
Catheter site pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0012 affected31 at risk
Chest discomfort	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0010 affected31 at risk
Injection site erythema	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Injection site pruritus	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected30 at risk EG0011 affected31 at risk
Puncture site haemorrhage	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Sinusitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Alanine aminotransferase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0011 affected31 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0012 affected31 at risk
Blood albumin decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0004 affected30 at risk EG0012 affected31 at risk
Blood calcium decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Blood phosphorus increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Blood uric acid decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Haematocrit decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0013 affected31 at risk
Haemoglobin decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
International normalised ratio increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0010 affected31 at risk
Lymphocyte count decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0004 affected30 at risk EG0013 affected31 at risk
Lymphocyte percentage decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Mean cell haemoglobin concentration decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Monocyte count increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0012 affected31 at risk
Neutrophil count increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Platelet count decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG00014 affected30 at risk EG0018 affected31 at risk
Protein total	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Protein total decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0011 affected31 at risk
Red blood cell count decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0011 affected31 at risk
Red cell distribution width increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
White blood cell count increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0004 affected30 at risk EG0014 affected31 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0012 affected31 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected30 at risk EG0012 affected31 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected30 at risk EG0015 affected31 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected30 at risk EG0017 affected31 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected30 at risk EG0016 affected31 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0014 affected31 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0012 affected31 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0010 affected31 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0011 affected31 at risk
Anaesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0012 affected31 at risk
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0012 affected31 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected30 at risk EG0012 affected31 at risk
Monoplegia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Paraesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Anxiety	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0010 affected31 at risk
Insomnia	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected30 at risk EG0011 affected31 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected30 at risk EG0010 affected31 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected30 at risk EG0011 affected31 at risk

ID	Term
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D000069585	Filgrastim
C088327	plerixafor

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

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.