Healthy Stem Cell DonorPhase 3NCT01149096
Collection of Bone Marrow From Donors Treated With or Without Filgrastim
A Phase 3 study testing Bone Marrow Donation, Filgrastim and Laboratory Biomarker Analysis in people with Healthy Stem Cell Donor and No Evidence of Disease, run by Children's Oncology Group at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Stem Cell Donor, No Evidence of Disease
- What is being tested?
- Bone Marrow Donation, Filgrastim and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 22 sitesUnited States
- Study dates
- 14 Jun 2010to 30 Sep 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Hospital Colorado
Aurora, Colorado, 80045
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Norton Children's Hospital
Louisville, Kentucky, 40202
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Childrens Oncology Group
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Primary Children's Hospital
Salt Lake City, Utah, 84113
UCSF Medical Center-Parnassus
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
New York Medical College
Valhalla, New York, 10595
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Healthy Stem Cell Donor, No Evidence of Disease
- Being tested
- Bone Marrow Donation, Filgrastim, Laboratory Biomarker Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow DonationProcedure or surgery
Undergo bone marrow harvest
FilgrastimBiological
Also called G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
Given subcutaneously
Laboratory Biomarker AnalysisOther
Optional correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (conventional bone marrow harvest) | Active comparator | Donors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0. Receives: Procedure: Bone Marrow Donation; Other: Laboratory Biomarker Analysis |
| 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. Receives: Procedure: Bone Marrow Donation; Biological: Filgrastim; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 10 years post bone marrow harvest
Secondary outcomes (4)
Absolute T Cell Numbers
Median and interquartile range of the outcome measure in standard BM and G-BM donors.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year after donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study start14 Jun 2010
- Primary completion14 Dec 2011
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Stem Cell DonorStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephan A Grupp, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149096
- Sponsor's protocol ID
- ASCT0631D
- Other IDs
- NCI-2011-02237, CDR0000675536, COG-ASCT0631D, ASCT0631D, ASCT0631D, U10CA098543
- Status last verified
- Sep 2019
- First submitted
- 22 Jun 2010
- Last updated
- 26 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01149096
- Acronym / sponsor ID
- ASCT0631D
- Conditions
- Healthy Stem Cell Donor, No Evidence of Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Jun 2010 (actual)
- Primary completion
- 14 Dec 2011 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 23 Jun 2010 (estimated)
- Results
- Posted 26 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (conventional bone marrow harvest) | Active comparator | Procedure: Bone Marrow Donation, Other: Laboratory Biomarker AnalysisDonors undergo conventional (i.e., unstimulated) bone marrow harvest on day 0. |
| Arm II (filgrastim, bone marrow harvest) | Experimental | Procedure: Bone Marrow Donation, Biological: Filgrastim, Other: Laboratory Biomarker AnalysisDonors receive filgrastim subcutaneously on days -4 through 0. Donors then undergo bone marrow harvest on day 0. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow DonationUndergo bone marrow harvest | Procedure or surgery | Arm I (conventional bone marrow harvest), Arm II (filgrastim, bone marrow harvest) |
| FilgrastimAlso: G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating FactorGiven subcutaneously | Biological | Arm II (filgrastim, bone marrow harvest) |
| Laboratory Biomarker AnalysisOptional correlative studies | Other | Arm I (conventional bone marrow harvest), Arm II (filgrastim, bone marrow harvest) |
Primary outcome
Percentage of Participants With Short-term Adverse Events in G-CSF (Filgrastim) Stimulated Bone Marrow (G-BM) Donors
Time frame: Up to 1 year after donation
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.
Percentage of Participants Who Experienced Death in G-CSF Stimulated-bone Marrow (G-BM) Donors
Time frame: Up to 1 year after donation
The Kaplan-Meier method will be used to estimate the cumulative incidence of death event in G-BM donors only.
Percentage of Participants With Grade 1 or 2 Toxicities
Time frame: Up to 1 year after donation
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.
Percentage of Participants With Grade 3 or 4 Toxicities
Time frame: Up to 1 year after donation
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.
10-year Mortality Rate in Marrow Donors
Time frame: Up to 10 years post bone marrow harvest
The Kaplan-Meier method will be used to estimate overall survival probabilities in standard BM and G-BM donors.
10-year Overall Cancer Incidence
Time frame: Up to 10 years post bone marrow harvest
The Kaplan-Meier method will be used to estimate overall cancer free probabilities in standard BM and G-BM donors.
10-year Hematologic Cancer Rate
Time frame: Up to 10 years post bone marrow harvest
The Kaplan-Meier method will be used to estimate hematologic cancer probabilities in standard BM and G-BM donors.
4 secondary outcomes
Absolute T Cell Numbers
Time frame: Up to 1 year after donation
Th1 vs. Th2 Profile of T Cells
Time frame: Up to 1 year after donation
Dendritic Cell (DC) Populations
Time frame: Up to 1 year after donation
T Regulatory Cell Content
Time frame: Up to 1 year after donation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Single-Dose vs. Divided-Dose G-CSF for Stem Cell Mobilization in Healthy Allogeneic Donors
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Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan A Grupp principal investigator
Children's Oncology Group
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bone Marrow Donation, Filgrastim and Laboratory Biomarker Analysis in people with Healthy Stem Cell Donor and No Evidence of Disease, run by Children's Oncology Group at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Short-term Adverse Events in G-CSF (Filgrastim) Stimulated Bone Marrow (G-BM) Donors (time frame: Up to 1 year after donation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.