CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
AMD 3100 (Mozobil plerixafor) +1 moredrug
Likely dose
G-CSF 10 mcg/kg/day for 5 days followed by AMD3100 (plerixafor) 240 mcg/kg as single subcutaneous injectionAI-extracted
Key inclusion· 6
  • ✓Age 18-60 years
  • ✓Weight greater than 60 kg
  • ✓Normal renal function (creatinine <1.5 mg/dL)
  • ✓Normal liver function (bilirubin <1.5 mg/dL, transaminases within normal limit)
Key exclusion· 9
  • ✕Active infection or positive test for syphilis, hepatitis B/C, HIV, or HTLV-1
  • ✕History of autoimmune disease such as rheumatoid arthritis or systemic lupus erythematous
  • ✕History of cancer within past 5 years (excluding nonmelanoma skin cancer)
  • ✕History of hematologic disorders including thromboembolic disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00082329
NCT00082329Phase 2Completed
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Peripheral Blood Hematopoietic Progenitor Cell Mobilization Using Granulocyte Colony Stimulating Factor (G-CSF) Combined With AMD3100 Mozobil (Plerixafor) in Healthy Volunteers

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted May 6, 2004·Updated Jul 22, 2021

In Brief

A Phase 2 clinical trial evaluating AMD 3100 (Mozobil plerixafor) and Granulocyte colony-stimulating factor (G-CSF) for Healthy. Completed, enrolled 9 participants across 1 site.

Detailed Summary

This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than the use of G-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell donors to mobilize, or push, stem cells out of the bone marrow and into the blood circulation for collection for transplantation. Although a sufficient quantity of cells usually can be collected with G-CSF treatment, some donors do not respond well and may require multiple apheresis procedures (see below) to collect enough cells. Studies indicate that G-CSF used together with a drug called AMD3100 may be more effective in mobilizing stem cells for collection than G-CSF alone. The Food and Drug Administration has approved G-CSF for stem cell mobilization. AMD3100 is a new drug that also mobilizes stem cells in large numbers within a few hours. Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 6, 2004
Enrollment StartJun 18, 2004
Primary CompletionOct 25, 2012
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 22.2 years ago

Interventions

AMD 3100 (Mozobil plerixafor)drug

Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.

Granulocyte colony-stimulating factor (G-CSF)drug

Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.