Trial Outcomes & Findings for AMD 3100 (Mozobil Plerixafor) to Mobilize Stem Cells for Donation (NCT NCT00075335)
NCT ID: NCT00075335
Last Updated: 2018-02-07
Results Overview
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.
COMPLETED
PHASE2
8 participants
1 Day
2018-02-07
Participant Flow
Participant milestones
| Measure |
AMD 3100 (Mozobil Plerixafor ) Volunteers
Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers. AMD 3100 volunteer response to peripheral blood stem cell mobilization
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AMD 3100 (Mozobil Plerixafor) to Mobilize Stem Cells for Donation
Baseline characteristics by cohort
| Measure |
AMD 3100 (Mozobil Plerixafor ) Volunteers
n=8 Participants
Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 DayPopulation: 8 Subjects received G-CSF for 5 days.
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.
Outcome measures
| Measure |
AMD 3100 Volunteers
n=8 Participants
Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
|
|---|---|
|
Change in Cytokine Gene Expression Profiles (84 Genes) in T Cells Following G-CSF Administration
|
16 unique cytokine genes affected
|
PRIMARY outcome
Timeframe: 1 DayPopulation: Subjects who received plexirxafor 240mcg/kg. Data was collected 6 hours after injection.
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.
Outcome measures
| Measure |
AMD 3100 Volunteers
n=8 Participants
Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
|
|---|---|
|
Change in Cytokine Gene Expression Profiles (84 Genes) in T Cells Following Plerixafor Administration
|
0 unique cytokine genes affected
|
Adverse Events
AMD 3100 (Mozobil Plerixafor ) Volunteers
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AMD 3100 (Mozobil Plerixafor ) Volunteers
n=8 participants at risk
Peripheral blood hematopoietic progenitor cell mobilization with AMD 3100 (Mozobil plerixafor) in healthy volunteers
|
|---|---|
|
Blood and lymphatic system disorders
elevated LDH
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
elevated Lymphs (efficacy measure)
|
87.5%
7/8
|
|
Blood and lymphatic system disorders
elevated lymphs (expected)
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
elevated Monos (expected)
|
100.0%
8/8
|
|
Blood and lymphatic system disorders
elevated Polys (expected)
|
100.0%
8/8
|
|
Blood and lymphatic system disorders
elevated WBCs (expected)
|
100.0%
8/8
|
|
Cardiac disorders
Sinus tachycardia (rate 103)
|
12.5%
1/8
|
|
Ear and labyrinth disorders
auditory (R ear) pain
|
12.5%
1/8
|
|
Gastrointestinal disorders
Cramps, abdominal
|
12.5%
1/8
|
|
Gastrointestinal disorders
feel need to vomit, no nausea
|
12.5%
1/8
|
|
General disorders
Headache
|
25.0%
2/8
|
|
General disorders
Hot feeling
|
12.5%
1/8
|
|
General disorders
Swelling, leg
|
12.5%
1/8
|
|
Immune system disorders
Injection site (erythema)
|
62.5%
5/8
|
|
Immune system disorders
Injection site (induration)
|
25.0%
2/8
|
|
Immune system disorders
Injection site (pain)
|
37.5%
3/8
|
|
Immune system disorders
Injection site (pruritus)
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
12.5%
1/8
|
|
Nervous system disorders
paresthesia (facial tingling)
|
37.5%
3/8
|
|
Nervous system disorders
Syncope
|
25.0%
2/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place