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NCT01149096 · ClinicalTrials.gov registry record · Phase 3
Collection of Bone Marrow From Donors Treated With or Without Filgrastim
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 13
- Enrollment target
NCT01149096: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT01149096 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 13 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01149096, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 13 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Filgrastim
- PROCEDURE Bone Marrow Donation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-06-14 |
| Est. Completion | 2016-09-30 |
| Phase | Phase 3 |
What the finished NCT01149096 record still lists
NCT01149096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01149096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01149096 about?
NCT01149096 is a clinical study titled "Collection of Bone Marrow From Donors Treated With or Without Filgrastim". 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 s...
What is the current status of trial NCT01149096?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2010-06-14. Estimated completion is 2016-09-30.
What interventions are being tested in trial NCT01149096?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Filgrastim (BIOLOGICAL), Bone Marrow Donation (PROCEDURE).
Who is sponsoring clinical trial NCT01149096?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01149096's enrollment target sits among peer trials
13 1984th of 2000 higher than 17 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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