Collection of Bone Marrow From Donors Treated With or Without Filgrastim

Children's Oncology Group

Status and phase: Completed; Phase 3

Conditions: Healthy Stem Cell Donor; No Evidence of Disease

Treatments: Other: Laboratory Biomarker Analysis; Biological: Filgrastim; Procedure: Bone Marrow Donation

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT01149096

ASCT0631D (Other Identifier)

CDR0000675536

U10CA098543 (U.S. NIH Grant/Contract)

NCI-2011-02237 (Registry Identifier)

COG-ASCT0631D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Arm I (conventional bone marrow harvest)

Active Comparator group

Description:

Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Bone Marrow Donation

Arm II (filgrastim, bone marrow harvest)

Experimental group

Description:

Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0.

Treatment:

Other: Laboratory Biomarker Analysis

Procedure: Bone Marrow Donation

Biological: Filgrastim