A Comparison of Acute and Long-term Toxicities in Bone Marrow Donors With and Without G-CSF Treatment Prior to Harvest: A Companion Study to ASCT0631
- To evaluate short- and long-term toxicities in bone marrow donors treated with vs
without filgrastim before harvest.
- To compare 10-year mortality and cancer in donors treated with vs without filgrastim.
- To correlate the incidence of acute and chronic graft-vs-host disease in the marrow
recipients enrolled on COG-ASCT0631 with four parameters assessed in the bone marrow
harvests: absolute T-cell numbers, Th1 vs Th2 profile of T-cells, dendritic cell
populations, and T-regulatory cell content.
OUTLINE: This is a multicenter study. Donors are stratified according to the disease risk of
the bone marrow recipient (high vs intermediate vs standard) and are randomized to 1 of 2
- Arm I (unstimulated harvest): Donors undergo conventional (i.e., unstimulated) bone
marrow harvest on day 0.
- Arm II (stimulated harvest): Donors receive filgrastim subcutaneously on days -4
through 0. Donors then undergo bone marrow harvest on day 0.
Bone marrow samples may be collected for biology studies.
After completion of study treatment, donors are followed up at 1, 6, and 12 months and then
annually for up to 10 years.
Short- and long-term toxicities in marrow donors
Stephan A. Grupp, MD, PhD
Children's Hospital of Philadelphia
United States: Federal Government
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|New York Medical College||Valhalla, New York 10595|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Children's Mercy Hospital||Kansas City, Missouri 64108|
|All Children's Hospital||St. Petersburg, Florida 33701|
|Children's Memorial Hospital - Chicago||Chicago, Illinois 60614|
|Kosair Children's Hospital||Louisville, Kentucky 40202-3830|
|Rainbow Babies and Children's Hospital||Cleveland, Ohio 44106-5000|
|Primary Children's Medical Center||Salt Lake City, Utah 84113-1100|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|C.S. Mott Children's Hospital at University of Michigan Medical Center||Ann Arbor, Michigan 48109-0286|
|University of Mississippi Cancer Clinic||Jackson, Mississippi 39216-4505|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Nationwide Children's Hospital||Columbus, Ohio 43205-2696|
|Children's Hospital of Pittsburgh of UPMC||Pittsburgh, Pennsylvania 15213|
|Virginia Commonwealth University Massey Cancer Center||Richmond, Virginia 23298-0037|
|Riley's Children Cancer Center at Riley Hospital for Children||Indianapolis, Indiana 46202-5225|
|Children's Hospital Colorado Center for Cancer and Blood Disorders||Aurora, Colorado 80045|