At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 13 enrolled
Drug / intervention
Filgrastim +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Bone Marrow Donation, Filgrastim, and 1 other intervention for Healthy Stem Cell Donor and No Evidence of Disease. Completed, enrolled 13 participants across 22 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Stem Cell Donor, No Evidence of Disease
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJun 2010
Primary CompletionDec 2011
Study CompletionSep 2016
TodayJul 2026
First PostedJun 23, 2010
Enrollment StartJun 14, 2010
Primary CompletionDec 14, 2011
Study CompletionSep 30, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.0 years ago
Interventions
Bone Marrow Donationprocedure
Undergo bone marrow harvest
Filgrastimbiological
Given subcutaneously
Laboratory Biomarker Analysisother
Optional correlative studies