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NCT00322127 · ClinicalTrials.gov registry record · Phase 1
An Evaluation of Safety and Efficacy of Escalating Doses of AMD3100 to Mobilize CD34+ Cells in Healthy Volunteers
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT00322127 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 44 participants.
The verdict
NCT00322127, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
This study will determine how safely and well people can tolerate AMD3100 at larger than normal doses to mobilize CD34+ cells, (stem cells). AMD3100 is a new drug designed to mobilize stem cells for transplantation in cancer patients. It pushes those cells into the circulation, making it easier to collect them, and it temporarily increases the number of stem cells in a person's blood. Patients ages 18 to 50 in good health and who are not pregnant or breastfeeding may be eligible for this study. They will undergo the following tests and procedures: * History and physical examination * Review of medications, including those prescribed and over-the-counter, as well as nutritional supplements * Blood tests for liver, kidneys, and other functions; and for infections including hepatitis and AIDS * Pregnancy test * Electrocardiogram On the day they receive AMD3100, patients will be admitted to the Clinical Center. They will receive two doses, injected under the skin, at intervals separated by 14 to 90 days. Dose levels are 240 and 320 micrograms/kg and 400 and 480 micrograms/kg. For 24 hours following the first AMD3100 administration, blood will be collected periodically through a plastic tube at amounts dependent on doses of AMD3100 given. If patients receive one of the two highest doses, their heart rhythm will be monitored continuously during the hospital stay. From 7 to 10 days following administration of AMD3100, patients will give blood samples to monitor the effects. The second dose of AMD3100 will be given 14 to 90 days after the first one. Patients will return to the Clinical Center for the same procedures as done previously, but the dose of the drug will be higher. Risks involve side effects of AMD3100. In previous studies, patients who received the drug experienced a temporary increase in white blood cell counts. Serious side effects have included abnormally low platelet clot, abnormal heart rhythm, and low blood pressure. Patients will be carefully monitore
Interventions
- DRUG AMD3100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2006-06-14 |
| Est. Completion | 2015-01-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00322127
The ClinicalTrials.gov registry entry for NCT00322127 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AMD3100 is the first listed.
NCT00322127 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00322127 about?
NCT00322127 is a clinical study titled "An Evaluation of Safety and Efficacy of Escalating Doses of AMD3100 to Mobilize CD34+ Cells in Healthy Volunteers". This study will determine how safely and well people can tolerate AMD3100 at larger than normal doses to mobilize CD34+ cells, (stem cells). AMD3100 is a new drug designed to mobilize stem cells for transplantation in cancer patients. It pushes those cells into the circulation, making it easier to c...
What is the current status of trial NCT00322127?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2006-06-14. Estimated completion is 2015-01-23.
What interventions are being tested in trial NCT00322127?
The interventions under investigation include: AMD3100 (DRUG).
Who is sponsoring clinical trial NCT00322127?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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