Collection of Bone Marrow From Donors Treated With or Without Filgrastim
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
5 other identifiers
interventional
13
1 country
22
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), to donors helps the stem cells move from the bone marrow to the blood so they can be collected and stored.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2010
Longer than P75 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2010
CompletedFirst Submitted
Initial submission to the registry
June 22, 2010
CompletedFirst Posted
Study publicly available on registry
June 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2016
CompletedResults Posted
Study results publicly available
February 26, 2020
CompletedFebruary 26, 2020
September 1, 2019
1.5 years
June 22, 2010
December 18, 2019
February 13, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
Percentage of Participants With Short-term Adverse Events in G-CSF (Filgrastim) Stimulated Bone Marrow (G-BM) Donors
The Kaplan-Meier method will be used to estimate the cumulative incidence of short term adverse events defined by having any of the following events: 1) death due to a cause that is unknown or possibly related to G-CSF, 2) development of a malignancy, 3) development of a splenic rupture, or 4) development of a severe acute lung injury possibly related to GCSF therapy.
Up to 1 year after donation
Percentage of Participants Who Experienced Death in G-CSF Stimulated-bone Marrow (G-BM) Donors
The Kaplan-Meier method will be used to estimate the cumulative incidence of death event in G-BM donors only.
Up to 1 year after donation
Percentage of Participants With Grade 1 or 2 Toxicities
Estimate the percentage of patients having non-fatal complications of CTCAE Grades 1 or 2 in standard BM and G-CSF stimulated-bone marrow (G-BM) donors.
Up to 1 year after donation
Percentage of Participants With Grade 3 or 4 Toxicities
Estimate the percentage of patients having non-fatal complications of Grade 3 other than pain (consider Grade 4 for pain only), or any of Grade 4 in standard BM and G-CSF stimulated-bone marrow (G-BM) donors. Modified Toxicity Criteria and Pain Assessment was used with higher grades corresponding to more severe AEs.
Up to 1 year after donation
10-year Mortality Rate in Marrow Donors
The Kaplan-Meier method will be used to estimate overall survival probabilities in standard BM and G-BM donors.
Up to 10 years post bone marrow harvest
10-year Overall Cancer Incidence
The Kaplan-Meier method will be used to estimate overall cancer free probabilities in standard BM and G-BM donors.
Up to 10 years post bone marrow harvest
10-year Hematologic Cancer Rate
The Kaplan-Meier method will be used to estimate hematologic cancer probabilities in standard BM and G-BM donors.
Up to 10 years post bone marrow harvest
Secondary Outcomes (4)
Absolute T Cell Numbers
Up to 1 year after donation
Th1 vs. Th2 Profile of T Cells
Up to 1 year after donation
Dendritic Cell (DC) Populations
Up to 1 year after donation
T Regulatory Cell Content
Up to 1 year after donation
Study Arms (2)
Arm I (conventional bone marrow harvest)
ACTIVE COMPARATORDonors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0.
Arm II (filgrastim, bone marrow harvest)
EXPERIMENTALDonors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0.
Interventions
Undergo bone marrow harvest
Given subcutaneously
Optional correlative studies
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (22)
UCSF Medical Center-Parnassus
San Francisco, California, 94143, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
New York Medical College
Valhalla, New York, 10595, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Childrens Oncology Group
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Results Reporting Coordinator
- Organization
- Children's Oncology Group
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan A Grupp
Children's Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2010
First Posted
June 23, 2010
Study Start
June 14, 2010
Primary Completion
December 14, 2011
Study Completion
September 30, 2016
Last Updated
February 26, 2020
Results First Posted
February 26, 2020
Record last verified: 2019-09