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AMD 3100 (Mozobil Plerixafor) to Mobilize Stem Cells for Donation

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ClinicalTrials.gov Identifier: NCT00075335
Recruitment Status : Completed
First Posted : January 9, 2004
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Childs, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Intervention Drug: AMD3100 (Mozobil plerixafor)
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AMD 3100 (Mozobil Plerixafor ) Volunteers
Hide Arm/Group Description Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers. AMD 3100 volunteer response to peripheral blood stem cell mobilization
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title AMD 3100 (Mozobil Plerixafor ) Volunteers
Hide Arm/Group Description Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
3
  37.5%
Male
5
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Change in Cytokine Gene Expression Profiles (84 Genes) in T Cells Following G-CSF Administration
Hide Description Examine G-CSF mobilization effect on cytokine polarization of T-cells. Analyze cytokine gene expression profiles using a Th1-Th2-Th3 RT-PCR plate in CD3+ T cells collected form subjects mobilized with 5 injections of G-CSF. 84 cytokine genes were analyzed for significant alteration in their profiles.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
8 Subjects received G-CSF for 5 days.
Arm/Group Title AMD 3100 Volunteers
Hide Arm/Group Description:
Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: unique cytokine genes affected
16
2.Primary Outcome
Title Change in Cytokine Gene Expression Profiles (84 Genes) in T Cells Following Plerixafor Administration
Hide Description Examine plerixafor mobilization effect on cytokine polarization of T-cells. Analyze cytokine gene expression profiles using a Th1-Th2-Th3 RT-PCR plate in CD3+ T cells collected form subjects mobilized with a single injection of plerixafor. 84 cytokine genes were analyzed for significant alteration in their profiles.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received plexirxafor 240mcg/kg. Data was collected 6 hours after injection.
Arm/Group Title AMD 3100 Volunteers
Hide Arm/Group Description:
Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: unique cytokine genes affected
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AMD 3100 (Mozobil Plerixafor ) Volunteers
Hide Arm/Group Description Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
All-Cause Mortality
AMD 3100 (Mozobil Plerixafor ) Volunteers
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AMD 3100 (Mozobil Plerixafor ) Volunteers
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AMD 3100 (Mozobil Plerixafor ) Volunteers
Affected / at Risk (%)
Total   8/8 (100.00%) 
Blood and lymphatic system disorders   
elevated LDH *  1/8 (12.50%) 
elevated Lymphs (efficacy measure) *  7/8 (87.50%) 
elevated lymphs (expected) *  1/8 (12.50%) 
elevated Monos (expected) *  8/8 (100.00%) 
elevated Polys (expected) *  8/8 (100.00%) 
elevated WBCs (expected) *  8/8 (100.00%) 
Cardiac disorders   
Sinus tachycardia (rate 103) *  1/8 (12.50%) 
Ear and labyrinth disorders   
auditory (R ear) pain *  1/8 (12.50%) 
Gastrointestinal disorders   
Cramps, abdominal *  1/8 (12.50%) 
feel need to vomit, no nausea *  1/8 (12.50%) 
General disorders   
Headache *  2/8 (25.00%) 
Hot feeling *  1/8 (12.50%) 
Swelling, leg *  1/8 (12.50%) 
Immune system disorders   
Injection site (erythema) *  5/8 (62.50%) 
Injection site (induration) *  2/8 (25.00%) 
Injection site (pain) *  3/8 (37.50%) 
Injection site (pruritus) *  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders   
muscle pain *  1/8 (12.50%) 
Nervous system disorders   
paresthesia (facial tingling) *  3/8 (37.50%) 
Syncope *  2/8 (25.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Richard Childs
Organization: NHLBI NIH
Phone: 301-594-8008
EMail: childsr@nhlbi.nih.gov
Layout table for additonal information
Responsible Party: Richard Childs, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00075335     History of Changes
Other Study ID Numbers: 040078
04-H-0078 ( Other Identifier: NIH NHLBI )
First Submitted: January 8, 2004
First Posted: January 9, 2004
Results First Submitted: April 1, 2014
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018