Collection of Bone Marrow From Donors Treated With or Without Filgrastim

Completed · Phase 3

Conditions studied: Healthy Stem Cell Donor, No Evidence of Disease

In brief

This randomized clinical trial is studying the side effects of collection of bone marrow from donors treated with or without filgrastim. Giving colony-stimulating factors, such as filgrastim (G-CSF), to donors helps the stem cells move from the bone marrow to the blood so they can be collected and stored.

Key facts

Study ID

NCT01149096

Run by

Children's Oncology Group

People needed

13

Starts

2010-06-14

Expected to finish

2016-09-30

Last updated by the study team

2020-02-26

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Appropriately human leukocyte antigen (HLA)-matched (HLA, A, B, DRB1 identical or antigen mismatched [i.e., 5/6 or 6/6 antigens matched]) sibling of the bone marrow recipient enrolled on COG-ASCT0631
• Adequate size relative to the recipient (i.e., harvesting the maximum of 20 cc/kg from the donor would result in a bone marrow graft that will provide an adequate cell and volume dose to the recipient, in the opinion of the treating physician)
• Enrolled on the COG Umbrella Long-Term Follow-Up Study COG-ALTE05N1
• Not pregnant or nursing
• No human immunodeficiency virus (HIV) positivity
• No sickle cell trait or sickle cell anemia/disease
• Not at an increased risk from bone marrow donation after filgrastim administration due to a pre-existing medical condition, as determined by an independent physician separate from the research team
• None of the following:
• Active infection, especially pulmonary
• Splenomegaly or a history of splenic injury
• Active or recent pulmonary disease (i.e., pneumonia within the past 4 weeks)
• A condition that would make the donor unsuitable to donate, as determined by an independent physician separate from the research team
• No autoimmune disease

Where it is running

• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Norton Children's Hospital — Louisville, Kentucky, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• New York Medical College — Valhalla, New York, United States
• UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Childrens Oncology Group — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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