Status:
COMPLETED
Collection of Bone Marrow From Donors Treated With or Without Filgrastim
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Healthy Stem Cell Donor
No Evidence of Disease
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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), ...
Detailed Description
PRIMARY OBJECTIVES: 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 trea...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
June 14 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01149096
Start Date
June 14 2010
End Date
September 30 2016
Last Update
February 26 2020
Active Locations (22)
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1
UCSF Medical Center-Parnassus
San Francisco, California, United States, 94143
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
4
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611