Spleen Size in Peripheral Blood Stem Cell Donors

Completed

Conditions studied: Splenomegaly

In brief

This study will determine whether the spleen in people who donate stem cells (bone marrow cells collected from the blood) enlarges as a result of taking granulocyte colony-stimulating factor (G-CSF). Donors take this growth factor to maximize the amount of stem cells that can be collected for transplantation to patients with leukemia or other diseases. The study will also examine whether changes in the donor's white blood cell count, blood stem cell count, and blood chemistries can predict a change in spleen size. Stem cells donors take G-CSF for 5 to 6 days before donating. Besides increasing the number of stem cells and white blood cells in the bloodstream, the drug also causes some other temporary changes in blood chemistry. Many people who take G-CSF for a few days get a headache, feel an ache in their bones, or feel tired for a few days. About one-third of patients chronically treated with G-CSF to raise blood cell counts develop an enlarged spleen. It is not known if a brief 5- to 6-day course of G-CSF also affects the size of the spleen, but about 1 in 10,000 blood stem cell donors have had a spontaneous rupture of the spleen. Adults and children 18 years of age and older who are donating stem cells for relatives enrolled in clinical trials at the National Institutes of Health may participate in this study. They will donate stem cells according to the standard procedure, but will give an extra 15 milliliters (3 teaspoons) of blood both before receiving G-CSF and after donating stem cells. Donors' spleen size will be measured by ultrasound scanning of the abdomen three times: the day before receiving G-CSF, the day after donating the stem cells and 4 days after donating.

Key facts

Study ID

NCT00006148

Run by

National Institutes of Health Clinical Center (CC)

People needed

49

Starts

2000-08-01

Expected to finish

2004-06-01

Last updated by the study team

2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults and children 18 years of age or greater will be studied.
• Enrolled in a primary stem cell transplant protocol that has been approved by the IRB.
• Potential subjects are people donating PBSC concentrates for HLA-compatible relatives as part of IRB approved protocols or donating PBSCs for laboratory investigations.

You may not qualify if…

• Donors who cannot remain in the Bethesda area for an additional 4 to 5 days following their donations will be excluded from the third ultrasound.

Where it is running

• Warren G. Magnuson Clinical Center (CC) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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