Collection of Bone Marrow From Donors Treated With or Without Filgrastim

No Evidence of Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149096
• Other study ID #: ASCT0631D
• Secondary ID: NCI-2011-02237CD
• Status: Completed
• Phase: Phase 3
• Start date: June 14, 2010
• Est. completion date: September 30, 2016

Study information

• Verified date: September 2019
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 30, 2016
• Est. primary completion date: December 14, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Stem Cell Donor
• No Evidence of Disease

Intervention

Procedure:
• Bone Marrow Donation
Undergo bone marrow harvest

Biological:
• Filgrastim
Given subcutaneously

Other:
• Laboratory Biomarker Analysis
Optional correlative studies

Locations

Country	Name	City	State
United States	C S Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Lurie Children's Hospital-Chicago	Chicago	Illinois
United States	Rainbow Babies and Childrens Hospital	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	Norton Children's Hospital	Louisville	Kentucky
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Childrens Oncology Group	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	UCSF Medical Center-Parnassus	San Francisco	California
United States	New York Medical College	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Absolute T Cell Numbers	Median and interquartile range of the outcome measure in standard BM and G-BM donors.	Up to 1 year after donation
Secondary	Th1 vs. Th2 Profile of T Cells	Proportion of donors with Th1-T cell profile in standard BM and G-BM donors.	Up to 1 year after donation
Secondary	Dendritic Cell (DC) Populations	Median and interquartile range of the outcome measure in standard BM and G-BM donors.	Up to 1 year after donation
Secondary	T Regulatory Cell Content	Median and interquartile range of the outcome measure in standard BM and G-BM donors.	Up to 1 year after donation