CytokinesPhase 2NCT00646763
A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation
A Phase 2 study testing G-CSF, GM-CSF administered at extremities and G-CSF and GMCSF administered at abdomen in people with Cytokines, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytokines
- What is being tested?
- G-CSF, GM-CSF administered at extremities and G-CSF and GMCSF administered at abdomen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2011
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with myeloma. All patients must meet criteria for transplantation.
Who cannot join
- Patients with active, invasive/systemic fungal infection.
- Patients who are pregnant or lactating females.
- Patients with active CNS malignant disease or life expectancy limited by diseases other than the disease for which the patient is being transplanted.
- Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: A Phase II Single Institution Randomized Study Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients Undergoing Autologous Hematopoietic Progenitor Cell Transplant
The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.
Read the detailed description
The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood.
Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.
- Conditions
- Cytokines
- Being tested
- G-CSF, GM-CSF administered at extremities, G-CSF and GMCSF administered at abdomen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF, GM-CSF administered at extremitiesDrug
Also called Neupogen, Leukine, growth factors
Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete.
G-CSF and GMCSF administered at abdomenDrug
Also called Neupogen, Leukine, growth factors
Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete.
| Study group | Role | What they receive |
|---|---|---|
| Abdomen | Active comparator | These subjects will have their cytokine injections administered only to their abdomen. Receives: Drug: G-CSF and GMCSF administered at abdomen |
| Extremities | Active comparator | The extremity arm will have their injections administered to their upper and/or lower extremities. Receives: Drug: G-CSF, GM-CSF administered at extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Number of CD34+ Cells Collected.
Measured: 4 days
Number of Participants for Whom Target Number of CD34+ Cells Were Collected.
Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment
Measured: 7 days
Secondary outcomes (1)
Total Number of Days of Apheresis
the number of days of apheresis required to collect target numbers of CD34+ cells.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionFeb 2011
Why it stopped: Accrual goal met
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 CytokinesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edmund Waller, Emory University
- Investigators
- Edmund Waller, MD, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646763
- Sponsor's protocol ID
- IRB00007445
- Other IDs
- 7445
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2008
- Last updated
- 1 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single Institution Randomized Study Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients Undergoing Autologous Hematopoietic Progenitor Cell Transplant
- ClinicalTrials.gov ID
- NCT00646763
- Acronym / sponsor ID
- IRB00007445
- Conditions
- Cytokines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual goal met
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Posted 11 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.
Detailed description
The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood.
Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdomen | Active comparator | Drug: G-CSF and GMCSF administered at abdomenThese subjects will have their cytokine injections administered only to their abdomen. |
| Extremities | Active comparator | Drug: G-CSF, GM-CSF administered at extremitiesThe extremity arm will have their injections administered to their upper and/or lower extremities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with myeloma. All patients must meet criteria for transplantation.
Key exclusion criteria (4 listed)
- Patients with active, invasive/systemic fungal infection.
- Patients who are pregnant or lactating females.
- Patients with active CNS malignant disease or life expectancy limited by diseases other than the disease for which the patient is being transplanted.
- Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.
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 |
|---|---|---|
| G-CSF, GM-CSF administered at extremitiesAlso: Neupogen, Leukine, growth factorsInjection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete. | Drug | Extremities |
| G-CSF and GMCSF administered at abdomenAlso: Neupogen, Leukine, growth factorsInjection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete. | Drug | Abdomen |
Primary outcome
The Total Number of CD34+ Cells Collected.
Time frame: 4 days
Number of Participants for Whom Target Number of CD34+ Cells Were Collected.
Time frame: 7 days
Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment
1 secondary outcome
Total Number of Days of Apheresis
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Edmund Waller, MD principal investigator
Emory University Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G-CSF, GM-CSF administered at extremities and G-CSF and GMCSF administered at abdomen in people with Cytokines, run by Emory University at 1 site 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 May 2012). 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?
The Total Number of CD34+ Cells Collected. (time frame: 4 days). The study lists 2 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 1 Apr 2025.