NCT00322127

An Evaluation of Safety and Efficacy of Escalating Doses of AMD3100 to Mobilize CD34+ Cells in Healthy Volunteers

Completed Phase 1 Last updated 8 October 2020

What this trial tests

Phase 1 trial testing AMD3100 in Healthy Volunteers in 44 participants. Completed in 23 January 2015.

Timeline

14 June 2006

Primary endpoint
23 January 2015

23 January 2015

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	14 June 2006
Primary completion	23 January 2015
Estimated completion	23 January 2015
Sites	1 location across United States

Drugs / interventions tested

• AMD3100 — full drug profile →

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 18 to 50, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 monitored for such effects.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of chemokine systems in cancer and inflammatory diseases.
   Li H, Wu M, Zhao X. · · 2022 · cited 85× · PMID 35702353 · DOI 10.1002/mco2.147
2. Effect of high-dose plerixafor on CD34⁺ cell mobilization in healthy stem cell donors: results of a randomized crossover trial.
   Pantin J, Purev E, Tian X, Cook L, et al · · 2017 · cited 44× · PMID 27846612 · DOI 10.3324/haematol.2016.147132