Phase 3
Completed N=13
Collection of Bone Marrow From Donors Treated With or Without Filgrastim
Healthy Stem Cell Donor · No Evidence of Disease
Source: ClinicalTrials.gov NCT01149096 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Percentage of Participants With Short-term Adverse Events in G-CSF (Filgrastim) Stimulated Bone Marrow (G-BM) Donors — 0 Percentage of patients
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Short-term Adverse Events in G-CSF (Filgrastim) Stimulated Bone Marrow (G-BM) Donors |
— | — |
| PRIMARY Percentage of Participants Who Experienced Death in G-CSF Stimulated-bone Marrow (G-BM) Donors |
— | — |
| PRIMARY Percentage of Participants With Grade 1 or 2 Toxicities |
67; 86 | — |
| PRIMARY Percentage of Participants With Grade 3 or 4 Toxicities |
0; 0 | — |
| PRIMARY 10-year Mortality Rate in Marrow Donors |
— | — |
| PRIMARY 10-year Overall Cancer Incidence |
— | — |
| PRIMARY 10-year Hematologic Cancer Rate |
— | — |
| SECONDARY Absolute T Cell Numbers |
— | — |
| SECONDARY Th1 vs. Th2 Profile of T Cells |
— | — |
| SECONDARY Dendritic Cell (DC) Populations |
— | — |
| SECONDARY T Regulatory Cell Content |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01149096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.