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AMD3100 (Plerixafor) Added to a Mobilizing Regimen of Granulocyte-colony Stimulating Factor (G-CSF) to Increase the Number of Peripheral Blood Stem Cells (PBSCs) in Patients With Hodgkin's Disease

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ClinicalTrials.gov Identifier: NCT00396201
Recruitment Status : Completed
First Posted : November 6, 2006
Results First Posted : October 6, 2010
Last Update Posted : March 13, 2014
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hodgkin's Disease
Intervention Drug: G-CSF Plus Plerixafor
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description Participants with Hodgkin's disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with granulocyte-colony stimulating factor (G-CSF) [10 µg/kg each day (QD)] and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Period Title: Treatment Period
Started 22
Completed 22 [1]
Not Completed 0
[1]
Completed refers to completed all treatment visits.
Period Title: Follow-up Period
Started 21 [1]
Completed 21 [2]
Not Completed 0
[1]
Participants who had transplants. One had insufficient collection of cells so no transplant.
[2]
Follow-up visit 12 months post-transplant
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
34.0  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
13
  59.1%
Male
9
  40.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 22 participants
22
1.Primary Outcome
Title Proportion of Participants Who Achieved ≥5*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF
Hide Description The proportion of total participants who mobilized ≥5*10^6 CD34+ cells/kg based on data from local laboratories.
Time Frame Day 5 up to Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population which included all participants who received plerixafor.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: proportion of participants
Proportion achieving ≥5*10^6 CD34+ cells/kg 0.68
Proportion not achieving ≥5*10^6 CD34+ cells/kg 0.32
2.Secondary Outcome
Title Overall Participant Counts of Adverse Events During the Treatment Period
Hide Description

Adverse Events were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe and life-threatening) and relatedness (5 steps from 'not related' to 'definitely related') to study treatment. Time frame starts on the first day of G-CSF mobilization to the day prior to chemotherapy/ablative treatment in preparation for transplant.

See the separate Serious Adverse Event section for a summary of AEs the investigator assessed as serious.

Time Frame Day 0 - approximately day 38
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisting of all participants who received G-CSF and/or plerixafor.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
Reporting at least one AE 17
Severity - Mild 5
Severity - Moderate 11
Severity - Severe 1
Severity - Life Threatening 0
Relationship - Not Related 2
Relationship - Probably Not Related 1
Relationship - Possibly Related 12
Relationship - Probably Related 1
Relationship - Definitely Related 1
3.Secondary Outcome
Title Proportion of Participants Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor and G-CSF
Hide Description The proportion of total participants who mobilized ≥2*10^6 CD34+ cells/kg based on data from local laboratories.
Time Frame Day 5 up to day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population which included all participants who received plerixafor.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: proportion of participants
Proportion achieving ≥2*10^6 CD34+ cells/kg 0.95
Proportion not achieving ≥2*10^6 CD34+ cells/kg 0.05
4.Secondary Outcome
Title Fold (Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
Hide Description The fold increase was measured by fluorescence activated cell sorting (FACS) analysis using local laboratory data and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
Time Frame Days 4-5 (first dose of plerixafor to apheresis)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population which included all participants who received plerixafor and had pre- and post-plerixafor CD34+ cell counts available; 3 participants had missing results data and were not included.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: ratio
3.2  (1.1)
5.Secondary Outcome
Title Participant Counts Grouped by Number of Apheresis Days Required to Collect ≥ 5*10^6 CD34+ Cells/kg
Hide Description Counts of participants grouped by the number of apheresis days needed to collect a target for transplantation of ≥5*10^6 CD34+ cells/kg as determined by local laboratory data.
Time Frame Day 5 up to day 9
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population which included all participants who received plerixafor and achieved a target of ≥5*10^6 CD34+cells/kg
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
1 day of apheresis 7
2 days of apheresis 6
3 days of apheresis 2
6.Secondary Outcome
Title Number of Days Post-Transplantation to Polymorphonuclear Leukocyte (PMN) Engraftment
Hide Description Median number of days to PMN engraftment following transplantation. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.
Time Frame Up to Month 13 (up to 12 months post transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population which included all participants who received plerixafor and had a transplant.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 21
Median (Full Range)
Unit of Measure: days
9.0
(8.0 to 14.0)
7.Secondary Outcome
Title Number of Days Post Transplantation to Platelet (PLT) Engraftment
Hide Description Median number of days to PLT engraftment following transplantation. Engraftment success was evaluated according to local site practice. Time to engraftment corresponded to the first day that criteria were met.
Time Frame Up to Month 13 (up to 12 months post transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population which included all participants who received plerixafor and had a transplant. One participant's time to engraftment was unknown due to missing lab values.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: days
19.0
(11.0 to 29.0)
8.Secondary Outcome
Title Number of Participants With a Durable Graft at 12 Months
Hide Description Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation. A graft was considered durable if blood counts were normal (acceptable) and still met the criteria for PLT and PMN engraftment.
Time Frame 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population which included all participants who received plerixafor and had a transplant.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: participants
21
9.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) Following a Single Dose of Plerixafor
Hide Description Maximum plasma concentration (Cmax) of plerixafor following the first single dose of 240 ug/kg plerixafor administered.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
831  (183)
10.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax) Following a Single Dose of Plerixafor
Hide Description Time to maximum plasma concentration (Tmax) of plerixafor following the first single dose of 240 ug/kg plerixafor was determined from direct observation of the data.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: hours
0.6  (0.4)
11.Secondary Outcome
Title Half-life (T1/2) Following a Single Dose of Plerixafor
Hide Description Plasma elimination half-life (T1/2) following a single dose of 240 ug/kg plerixafor.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: hours
3.5  (0.7)
12.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From 0 to 10 Hours (AUC0-10) Following a Single Dose of Plerixafor
Hide Description Area under the plasma concentration-time curve from 0 to 10 hours (AUC0-10) following the first single dose of 240 ug/kg plerixafor.
Time Frame Days 4-5
Hide Outcome Measure Data
Hide Analysis Population Description
The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
3572  (772)
13.Secondary Outcome
Title Apparent Clearance (CL/F) of Single-dose Plerixafor
Hide Description Apparent clearance was calculated the mean dose of plerixafor divided by the area under the plasma concentration-time curve from 0 hours to infinity (AUC0-inf).
Time Frame Day 4-5
Hide Outcome Measure Data
Hide Analysis Population Description
The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mL/hr
5138  (2029)
14.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F) Following a Single-dose of Plerixafor
Hide Description The volume of distribution (Vz/F) was calculated as apparent clearance divided by the terminal elimination rate constant.
Time Frame Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
The last nine study participants had pharmacokinetic blood samples taken, as reflected in a protocol amendment. Results include participants from the last nine participants who had the relevant test data.
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description:
Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mL
25464  (9002)
Time Frame Day 1 (start of G-CSF Mobilization plus Treatment/Apheresis) to the day before starting chemotherapy. Chemotherapy typically started within 30 days of the last apheresis (which may have occurred on Day 5, 6, 7, or 8).
Adverse Event Reporting Description

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables.

Each AE table includes all events, regardless of reported relationship to study treatment or grade.

 
Arm/Group Title Participants With Hodgkin's Disease (HD)
Hide Arm/Group Description Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
All-Cause Mortality
Participants With Hodgkin's Disease (HD)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Participants With Hodgkin's Disease (HD)
Affected / at Risk (%)
Total   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Hodgkin's Disease (HD)
Affected / at Risk (%)
Total   17/22 (77.27%) 
Gastrointestinal disorders   
Abdominal discomfort  1  1/22 (4.55%) 
Abdominal pain  1  1/22 (4.55%) 
Diarrhoea  1  3/22 (13.64%) 
Hypoaesthesia oral  1  2/22 (9.09%) 
Nausea  1  6/22 (27.27%) 
Paraesthesia oral  1  4/22 (18.18%) 
Vomiting  1  2/22 (9.09%) 
General disorders   
Catheter site haematoma  1  1/22 (4.55%) 
Catheter site haemorrhage  1  1/22 (4.55%) 
Catheter site pain  1  1/22 (4.55%) 
Chills  1  2/22 (9.09%) 
Face oedema  1  1/22 (4.55%) 
Fatigue  1  5/22 (22.73%) 
Feeling hot  1  1/22 (4.55%) 
Injection site discharge  1  1/22 (4.55%) 
Injection site erythema  1  15/22 (68.18%) 
Injection site haemorrhage  1  3/22 (13.64%) 
Injection site irritation  1  1/22 (4.55%) 
Injection site swelling  1  1/22 (4.55%) 
Oedema peripheral  1  1/22 (4.55%) 
Pain  1  2/22 (9.09%) 
Pyrexia  1  1/22 (4.55%) 
Metabolism and nutrition disorders   
Hypocalcaemia  1  2/22 (9.09%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/22 (13.64%) 
Back pain  1  7/22 (31.82%) 
Bone pain  1  6/22 (27.27%) 
Muscle spasms  1  1/22 (4.55%) 
Musculoskeletal chest pain  1  3/22 (13.64%) 
Musculoskeletal pain  1  2/22 (9.09%) 
Neck pain  1  1/22 (4.55%) 
Pain in extremity  1  1/22 (4.55%) 
Nervous system disorders   
Dizziness  1  1/22 (4.55%) 
Headache  1  2/22 (9.09%) 
Hypoaesthesia  1  2/22 (9.09%) 
Neuropathy peripheral  1  1/22 (4.55%) 
Paraesthesia  1  5/22 (22.73%) 
Psychiatric disorders   
Nervousness  1  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/22 (4.55%) 
Pharyngolaryngeal pain  1  1/22 (4.55%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  1/22 (4.55%) 
Hypoaesthesia facial  1  2/22 (9.09%) 
Night sweats  1  1/22 (4.55%) 
Vascular disorders   
Pallor  1  2/22 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
In multi-site studies, PI can publish after Genzyme publishes or 18 months after study completion. PI gives Genzyme a draft 60 days before publication. Genzyme can ask that confidential information be removed, and can defer publication another 60 days upon notifying PI that it will file a patent application on inventions contained in the draft.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Genzyme Medical Information
Organization: Genzyme Corporation
Phone: 800-745-4447
Layout table for additonal information
Responsible Party: Medical Monitor, Genzyme
ClinicalTrials.gov Identifier: NCT00396201    
Other Study ID Numbers: AMD3100-2106
First Submitted: November 2, 2006
First Posted: November 6, 2006
Results First Submitted: February 10, 2009
Results First Posted: October 6, 2010
Last Update Posted: March 13, 2014