NCT01149096

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

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 treated with vs without filgrastim. SECONDARY OBJECTIVES: I. To correlate the incidence of acute and chronic graft-vs-host disease in the marrow recipients enrolled on COG-ASCT0631 with four parameters assessed in the bone marrow harvests: absolute T-cell numbers, Th1 vs Th2 profile of T-cells, dendritic cell populations, and T-regulatory cell content. OUTLINE: Donors are randomized to 1 of 2 treatment arms. ARM I (unstimulated harvest): Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0. ARM II (stimulated harvest): Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0. After completion of study treatment, donors are followed up at 1, 6, and 12 months and then annually for up to 10 years.

Conditions

• Healthy Stem Cell Donor
• No Evidence of Disease

Interventions

Type	Name	Description
PROCEDURE	Bone Marrow Donation	Undergo bone marrow harvest
BIOLOGICAL	Filgrastim	Given subcutaneously
OTHER	Laboratory Biomarker Analysis	Optional correlative studies

Timeline

• Start date: 2010-06-14
• Primary completion: 2011-12-14
• Completion: 2016-09-30
• First posted: 2010-06-23
• Last updated: 2020-02-26
• Results posted: 2020-02-26

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study