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| Sponsored by: |
Emory University |
|---|---|
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00208949 |
Purpose
This is a study involving patients who are undergoing allogeneic peripheral blood stem cell transplantation. Both donors and recipients are being sought for this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Diseases |
Drug: G-CSF Drug: GM-CSF |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Comparison of Dendritic Cell Content and T-Cell Phenotype Between G-CSF or G-CSF+GM-CSF for the Mobilization of Normal Allogeneic Peripheral Blood Stem Cell Donors |
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
B: Active Comparator
Single use of G-CSF
|
Drug: G-CSF
G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
|
|
A: Active Comparator
Combined use of G-CSF and GM-CSF
|
Drug: G-CSF
G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
Drug: GM-CSF
GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
|
Patients with leukemia will receive a stem cell transplant, prior to which they will receive medication and/or radiation to destroy all leukemia cells as well as other blood cells. In order to survive this treatment, patients will need to be given the stem cells from another person to replace the blood cells killed by the treatment.
The stem cells given to the recipient will be collected from a relative. To increase the number of stem cells in the relative, he/she is given a growth factor to increase the number of stem cells prior to collection. The standard growth factor used is called G-CSF. In this research study, the physician will give the relative either G-CSF or a combination of G-CSF and GM-CSF, another type of growth factor. Whether the relative receives G-CSF or GM-CSF will be determined by chance. The donors will be randomized to one or the other. It is not known if the stem cells and white blood cells collected using one or both growth factors results in more cures for this disease and fewer side effects, such as graft-versus-host disease.
The reason for doing the study is to determine if the stem cells and other white blood cells collected are any different when different growth factors are given, and to see how well the patient does. The stem cell transplant will in every other way be the same. The only difference is that if the recipient and donor decide to be in this study, the donor will either be given only G-CSF or the combination of G-CSF and GM-CSF and the recipient will receive the stem cells collected.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Martha Arellano, MD | 888-946-7447 |
| United States, Georgia | |
| Emory University Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Sagar Lonial, MD | |
| Principal Investigator: | Martha Arellano, MD | Emory University Winship Cancer Institute |
More Information
| Responsible Party: | Winship Cancer Institute ( Martha Arellano, MD ) |
| Study ID Numbers: | 0693-2002 |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00208949 |
| Health Authority: | United States: Institutional Review Board |
|
Hematologic Diseases |
|
Hematologic Diseases |
