Collection of Bone Marrow From Donors Treated With or Without Filgrastim

Children's Oncology Group13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Healthy Stem Cell Donor No Evidence of Disease

Interventions

Bone Marrow DonationPROCEDURE

Undergo bone marrow harvest

FilgrastimBIOLOGICAL

Given subcutaneously

Laboratory Biomarker AnalysisOTHER

Optional correlative studies

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (22)

UCSF Medical Center-Parnassus

San Francisco, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 1 year after donation

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.

Time frame: Up to 1 year after donation

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.

Time frame: Up to 1 year after donation

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.

Time frame: Up to 1 year after donation

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.

Time frame: Up to 10 years post bone marrow harvest

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.

Data from ClinicalTrials.gov

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Collection of Bone Marrow From Donors Treated With or Without Filgrastim

Overview

Conditions

Interventions

Eligibility

Locations (22)

Outcomes

Primary Outcomes

Secondary Outcomes