Spleen Size in Peripheral Blood Stem Cell Donors

NCT00006148 | Completed

• 2 other identifiers: 00019200-CC-0192
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Splenomegaly

Keywords

Granulocyte Colony - Stimulation Factor; Peripheral Blood Stem Cells; Splenomegaly

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Bensinger WI, Weaver CH, Appelbaum FR, Rowley S, Demirer T, Sanders J, Storb R, Buckner CD. Transplantation of allogeneic peripheral blood stem cells mobilized by recombinant human granulocyte colony-stimulating factor. Blood. 1995 Mar 15;85(6):1655-8.

  PMID: 7534140 BACKGROUND

• Korbling M, Przepiorka D, Huh YO, Engel H, van Besien K, Giralt S, Andersson B, Kleine HD, Seong D, Deisseroth AB, et al. Allogeneic blood stem cell transplantation for refractory leukemia and lymphoma: potential advantage of blood over marrow allografts. Blood. 1995 Mar 15;85(6):1659-65.

  PMID: 7888684 BACKGROUND

• Schmitz N, Dreger P, Suttorp M, Rohwedder EB, Haferlach T, Loffler H, Hunter A, Russell NH. Primary transplantation of allogeneic peripheral blood progenitor cells mobilized by filgrastim (granulocyte colony-stimulating factor). Blood. 1995 Mar 15;85(6):1666-72.

  PMID: 7534141 BACKGROUND

MeSH Terms

Conditions

Splenomegaly

Condition Hierarchy (Ancestors)

Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 8, 2000
• First Posted: August 9, 2000
• Study Start: August 1, 2000
• Study Completion: June 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-06

Locations

US (1)