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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
Not Enrolling
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



- 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.


- 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


- 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

- 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 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


- Not specified

Type of Study:


Study Design:


Outcome Measure:

Short- and long-term toxicities in marrow donors

Safety Issue:


Principal Investigator

Stephan A. Grupp, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital of Philadelphia


United States: Federal Government

Study ID:




Start Date:

June 2010

Completion Date:

Related Keywords:

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



Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
New York Medical College Valhalla, New York  10595
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Children's Mercy Hospital Kansas City, Missouri  64108
All Children's Hospital St. Petersburg, Florida  33701
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
Kosair Children's Hospital Louisville, Kentucky  40202-3830
Rainbow Babies and Children's Hospital Cleveland, Ohio  44106-5000
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor, Michigan  48109-0286
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Nationwide Children's Hospital Columbus, Ohio  43205-2696
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Riley's Children Cancer Center at Riley Hospital for Children Indianapolis, Indiana  46202-5225
Children's Hospital Colorado Center for Cancer and Blood Disorders Aurora, Colorado  80045