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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02237 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000675536 | |||
| COG-ASCT0631D | |||
| ASCT0631D | Other Identifier | Childrens Oncology Group | |
| ASCT0631D | Other Identifier | CTEP | |
| U10CA098543 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (conventional bone marrow harvest) | Active Comparator | Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0. |
|
| Arm II (filgrastim, bone marrow harvest) | Experimental | Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Donation | Procedure | Undergo bone marrow harvest |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Up to 10 years post bone marrow harvest |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute T Cell Numbers | Median and interquartile range of the outcome measure in standard BM and G-BM donors. | Up to 1 year after donation |
| Th1 vs. Th2 Profile of T Cells | Proportion of donors with Th1-T cell profile in standard BM and G-BM donors. |
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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:
No autoimmune disease
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| Name | Affiliation | Role |
|---|---|---|
| Stephan A Grupp | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | United States | ||
| Children's Hospital Colorado |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Conventional Bone Marrow Harvest) | Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0. Bone Marrow Donation: Undergo bone marrow harvest Laboratory Biomarker Analysis: Optional correlative studies |
| FG001 | Arm II (Filgrastim, Bone Marrow Harvest) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Filgrastim | Biological | Given subcutaneously |
|
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| Laboratory Biomarker Analysis | Other | Optional correlative studies |
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| 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. |
| Up to 10 years post bone marrow harvest |
| 10-year Hematologic Cancer Rate | The Kaplan-Meier method will be used to estimate hematologic cancer probabilities in standard BM and G-BM donors. | Up to 10 years post bone marrow harvest |
| Up to 1 year after donation |
| Dendritic Cell (DC) Populations | Median and interquartile range of the outcome measure in standard BM and G-BM donors. | Up to 1 year after donation |
| T Regulatory Cell Content | Median and interquartile range of the outcome measure in standard BM and G-BM donors. | Up to 1 year after donation |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Childrens Oncology Group | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0. Bone Marrow Donation: Undergo bone marrow harvest Filgrastim: Given subcutaneously Laboratory Biomarker Analysis: Optional correlative studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Conventional Bone Marrow Harvest) | Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0. Bone Marrow Donation: Undergo bone marrow harvest Laboratory Biomarker Analysis: Optional correlative studies |
| BG001 | Arm II (Filgrastim, Bone Marrow Harvest) | Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0. Bone Marrow Donation: Undergo bone marrow harvest Filgrastim: Given subcutaneously Laboratory Biomarker Analysis: Optional correlative studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis conducted within G-BM donors only, therefore, no report for the control arm (Conventional bone marrow transplant). | Posted | Number | Percentage of patients | Up to 1 year after donation |
|
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| ||||||||||||||||||||||||||
| Primary | 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. | Analysis conducted for stimulated-bone marrow (G-BM) donors only, therefore, no report on the control arm (Conventional bone marrow transplant). | Posted | Number | Percentage of patients | Up to 1 year after donation |
|
| |||||||||||||||||||||||||||
| Primary | 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. | Modified Toxicity Criteria and Pain Assessment was used with higher grades corresponding to more severe AEs. | Posted | Number | percentage of patients | Up to 1 year after donation |
|
| |||||||||||||||||||||||||||
| Primary | 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. | All patients included in analysis. No incidence of grades 3 or 4 toxicities. | Posted | Number | percentage of patients | Up to 1 year after donation |
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| |||||||||||||||||||||||||||
| Primary | 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. | Data were not collected as no patients were followed to 10 years. | Posted | Up to 10 years post bone marrow harvest |
|
| |||||||||||||||||||||||||||||
| Primary | 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 were not collected as no patients were followed to 10 years. | Posted | Up to 10 years post bone marrow harvest |
|
| |||||||||||||||||||||||||||||
| Primary | 10-year Hematologic Cancer Rate | The Kaplan-Meier method will be used to estimate hematologic cancer probabilities in standard BM and G-BM donors. | Data were not collected as no patients were followed to 10 years. | Posted | Up to 10 years post bone marrow harvest |
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| Secondary | Absolute T Cell Numbers | Median and interquartile range of the outcome measure in standard BM and G-BM donors. | Data were not collected for this study. | Posted | Up to 1 year after donation |
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| |||||||||||||||||||||||||||||
| Secondary | Th1 vs. Th2 Profile of T Cells | Proportion of donors with Th1-T cell profile in standard BM and G-BM donors. | Data were not collected for this study. | Posted | Up to 1 year after donation |
|
| |||||||||||||||||||||||||||||
| Secondary | Dendritic Cell (DC) Populations | Median and interquartile range of the outcome measure in standard BM and G-BM donors. | Data were not collected for this study. | Posted | Up to 1 year after donation |
|
| |||||||||||||||||||||||||||||
| Secondary | T Regulatory Cell Content | Median and interquartile range of the outcome measure in standard BM and G-BM donors. | Data were not collected for this study. | Posted | Up to 1 year after donation |
|
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First year after Bone Marrow Harvest
Modified Toxicity Criteria and Pain Assessment was used with higher grades corresponding to more severe AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Conventional Bone Marrow Harvest) | Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0. Bone Marrow Donation: Undergo bone marrow harvest Laboratory Biomarker Analysis: Optional correlative studies | 0 | 6 | 0 | 6 | 4 | 6 |
| EG001 | Arm II (Filgrastim, Bone Marrow Harvest) | Donors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0. Bone Marrow Donation: Undergo bone marrow harvest Filgrastim: Given subcutaneously Laboratory Biomarker Analysis: Optional correlative studies | 0 | 7 | 0 | 7 | 6 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | General disorders | Systematic Assessment |
| ||
| Bones (Including Sternum and Ribs) pain | General disorders | Systematic Assessment |
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| Dizziness, vertigo, or lightheadedness | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Fever in the absence of infections | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Hip pain | General disorders | Systematic Assessment |
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| IV Site pain | General disorders | Systematic Assessment |
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| Injection site reaction | General disorders | Systematic Assessment |
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| Insomnia (Inability to sleep) | General disorders | Systematic Assessment |
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| Joints (Excluding hip) pain | General disorders | Systematic Assessment |
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| Limbs (Arm, legs, hands feet) pain | General disorders | Systematic Assessment |
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| Loss of Appetite (Anorexia) | General disorders | Systematic Assessment |
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| Muscles pain | General disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Neck pain | General disorders | Systematic Assessment |
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| Other pain | General disorders | Systematic Assessment |
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| Rashes on skin | General disorders | Systematic Assessment |
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| Throat pain | General disorders | Systematic Assessment |
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| Vomiting | General disorders | Systematic Assessment |
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Must obtain prior approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 626-447-0064 | resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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