Clinical trial NCT00208949: A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF
Official title: A Randomized Comparison of Dendritic Cell Content and T-Cell Phenotype Between G-CSF(Granulocyte Colony-Stimulating Factor)or G-CSF+GM-CSF (Granulocyte Macrophage Colony-Stimulating Factor) for the Mobilization of Normal Allogeneic Peripheral Blood Stem Cell Donors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hematologic Diseases
Keywords: Hematologic Diseases
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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(Granulocyte Colony-Stimulating Factor ). In this research study, the physician will give the relative either G-CSF or a combination of G-CSF and GM-CSF (Granulocyte Macrophage (GM)) , 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 criteria: Inclusion Criteria:

* All normal donors for patients undergoing allogeneic peripheral blood stem cell (PBSC) for hematologic diseases will be invited to participate in this research trial.
* All patients must meet criteria for transplantation.
* Final eligibility will be determined by the health professionals conducting this clinical trial.

Exclusion Criteria:

* Donors for patients undergoing selected or manipulated PBSC grafts are not eligible.
* Donors who are pregnant or lactating females and donors with a known hypersensitivity to either G-CSF or GM-CSF will be excluded from this study.
* Final eligibility will be determined by the health professionals conducting this clinical trial.

Primary outcomes:
measure: Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft
timeFrame: at transplant (1 day)
Secondary outcomes:
measure: Median Survival of Recipients of Grafts Mobilized With GM+G+CSF (Granulocyte Colony-Stimulating Factor (G-CSF)+ Granulocyte Macrophage (GM)-CSF) and G-CSF (Granulocyte Colony-Stimulating Factor )at the Time of Last Follow up.
timeFrame: 5 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: Sagar Lonial, MD
role: PRINCIPAL_INVESTIGATOR
References: