Collection of Bone Marrow From Donors Treated With or Without Filgrastim
NCT ID: NCT01149096
Last Updated: 2020-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
13 participants
INTERVENTIONAL
2010-06-14
2016-09-30
Brief Summary
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Detailed Description
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I. To evaluate short- and long-term toxicities in bone marrow donors treated with vs without filgrastim before harvest.
II. To compare 10-year mortality and cancer in donors treated with vs without filgrastim.
SECONDARY OBJECTIVES:
I. 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: Donors are randomized to 1 of 2 treatment arms.
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.
After completion of study treatment, donors are followed up at 1, 6, and 12 months and then annually for up to 10 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (conventional bone marrow harvest)
Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0.
Bone Marrow Donation
Undergo bone marrow harvest
Laboratory Biomarker Analysis
Optional correlative studies
Arm II (filgrastim, bone marrow harvest)
Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0.
Bone Marrow Donation
Undergo bone marrow harvest
Filgrastim
Given subcutaneously
Laboratory Biomarker Analysis
Optional correlative studies
Interventions
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Bone Marrow Donation
Undergo bone marrow harvest
Filgrastim
Given subcutaneously
Laboratory Biomarker Analysis
Optional correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Stephan A Grupp
Role: PRINCIPAL_INVESTIGATOR
Children's Oncology Group
Locations
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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
Countries
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Other Identifiers
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NCI-2011-02237
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000675536
Identifier Type: -
Identifier Source: secondary_id
COG-ASCT0631D
Identifier Type: -
Identifier Source: secondary_id
ASCT0631D
Identifier Type: OTHER
Identifier Source: secondary_id
ASCT0631D
Identifier Type: OTHER
Identifier Source: secondary_id
ASCT0631D
Identifier Type: -
Identifier Source: org_study_id
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