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Collection of Bone Marrow From Donors Treated With or Without Filgrastim

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01149096
First received: June 22, 2010
Last updated: January 10, 2012
Last verified: November 2011
History of Changes
  Purpose

RATIONALE: 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.

PURPOSE: This randomized clinical trial is studying the side effects of collection of bone marrow from donors treated with or without filgrastim.


Condition Intervention Phase
Healthy, no Evidence of Disease
 Biological: filgrastim
Procedure: bone marrow donation
 Phase 3

Study Type: Observational
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Short- and long-term toxicities in marrow donors [ Designated as safety issue: Yes ]
  • 10-year mortality and cancer risk in marrow donors [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of acute and chronic graft-vs-host disease in marrow recipients [ Designated as safety issue: No ]

Estimated Enrollment: 425
Study Start Date: June 2010
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm I
Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0.
 Procedure: bone marrow donation
Donors undergo bone marrow harvest
Arm II
Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0.
 Biological: filgrastim
Given subcutaneously
Procedure: bone marrow donation
Donors undergo bone marrow harvest

Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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 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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Appropriately 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

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • No 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

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149096

  Hide Study Locations
Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
Children's Hospital Colorado Center for Cancer and Blood Disorders
Aurora, Colorado, United States, 80045
United States, Florida
All Children's Hospital
Saint Petersburg, Florida, United States, 33701
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
United States, Indiana
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0286
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St. Louis, Missouri, United States, 63110
United States, New York
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205-2696
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephan A. Grupp, MD, PhD Children's Hospital of Philadelphia
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01149096     History of Changes
Other Study ID Numbers: CDR0000675536, COG-ASCT0631D
Study First Received: June 22, 2010
Last Updated: January 10, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
healthy, no evidence of disease

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013