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A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF

Primary Purpose

Hematologic Diseases

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
G-CSF
GM-CSF
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Diseases focused on measuring Hematologic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University Winship Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

G-CSF(Granulocyte Colony-Stimulating Factor )

Granulocyte CSF+Granulocyte Macrophage CSF

Arm Description

Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day

Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)

Outcomes

Primary Outcome Measures

Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft

Secondary Outcome Measures

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.
Median overall survival

Full Information

First Posted
September 13, 2005
Last Updated
August 17, 2012
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00208949
Brief Title
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

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
September 2002 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases
Keywords
Hematologic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
G-CSF(Granulocyte Colony-Stimulating Factor )
Arm Type
Active Comparator
Arm Description
Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day
Arm Title
Granulocyte CSF+Granulocyte Macrophage CSF
Arm Type
Active Comparator
Arm Description
Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
Intervention Type
Drug
Intervention Name(s)
G-CSF
Other Intervention Name(s)
Rhu
Intervention Description
G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
Intervention Type
Drug
Intervention Name(s)
GM-CSF
Other Intervention Name(s)
NSC#617589
Intervention Description
GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
Primary Outcome Measure Information:
Title
Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft
Time Frame
at transplant (1 day)
Secondary Outcome Measure Information:
Title
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.
Description
Median overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sagar Lonial, MD
Organizational Affiliation
Emory University Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF

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