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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


Phase 3
N/A
N/A
Not Enrolling
Both
Healthy, no Evidence of Disease

Thank you

Trial Information

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


OBJECTIVES:

Primary

- To evaluate short- and long-term toxicities in bone marrow donors treated with vs
without filgrastim before harvest.

- To compare 10-year mortality and cancer in donors treated with vs without filgrastim.

Secondary

- 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: This is a multicenter study. Donors are stratified according to the disease risk of
the bone marrow recipient (high vs intermediate vs standard) and 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.

Bone marrow samples may be collected for biology studies.

After completion of study treatment, donors are followed up at 1, 6, and 12 months and then
annually for up to 10 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Appropriately 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

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- No 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

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Short- and long-term toxicities in marrow donors

Safety Issue:

Yes

Principal Investigator

Stephan A. Grupp, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital of Philadelphia

Authority:

United States: Federal Government

Study ID:

CDR0000675536

NCT ID:

NCT01149096

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease
  • healthy, no evidence of disease

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
New York Medical CollegeValhalla, New York  10595
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Children's Mercy HospitalKansas City, Missouri  64108
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Riley's Children Cancer Center at Riley Hospital for ChildrenIndianapolis, Indiana  46202-5225
Children's Hospital Colorado Center for Cancer and Blood DisordersAurora, Colorado  80045