Clinical trial NCT01149096: Collection of Bone Marrow From Donors Treated With or Without Filgrastim
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Stem Cell Donor
No Evidence of Disease
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-23
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Short-term Adverse Events in G-CSF (Filgrastim) Stimulated Bone Marrow (G-BM) Donors
timeFrame: Up to 1 year after donation
measure: Percentage of Participants Who Experienced Death in G-CSF Stimulated-bone Marrow (G-BM) Donors
timeFrame: Up to 1 year after donation
measure: Percentage of Participants With Grade 1 or 2 Toxicities
timeFrame: Up to 1 year after donation
measure: Percentage of Participants With Grade 3 or 4 Toxicities
timeFrame: Up to 1 year after donation
measure: 10-year Mortality Rate in Marrow Donors
timeFrame: Up to 10 years post bone marrow harvest
measure: 10-year Overall Cancer Incidence
timeFrame: Up to 10 years post bone marrow harvest
measure: 10-year Hematologic Cancer Rate
timeFrame: Up to 10 years post bone marrow harvest
Secondary outcomes:
measure: Absolute T Cell Numbers
timeFrame: Up to 1 year after donation
measure: Th1 vs. Th2 Profile of T Cells
timeFrame: Up to 1 year after donation
measure: Dendritic Cell (DC) Populations
timeFrame: Up to 1 year after donation
measure: T Regulatory Cell Content
timeFrame: Up to 1 year after donation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center-Parnassus
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Chicago
country: United States
facility: Lurie Children's Hospital-Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University/Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University/Sidney Kimmel Cancer Center
state: Maryland
city: Ann Arbor
country: United States
facility: C S Mott Children's Hospital
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: Rainbow Babies and Childrens Hospital
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Childrens Oncology Group
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Children's Oncology Group
name: Stephan A Grupp
role: PRINCIPAL_INVESTIGATOR
References: