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

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

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.

Study Overview

• Status: Terminated
• Conditions: Hematologic Diseases
• Intervention / Treatment: Drug: G-CSF; Drug: GM-CSF

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Winship Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: G-CSF(Granulocyte Colony-Stimulating Factor ); Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day	Drug: G-CSF; G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.; Other Names: Rhu
Active Comparator: Granulocyte CSF+Granulocyte Macrophage CSF; 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.)	Drug: G-CSF; G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.; Other Names: Rhu; Drug: GM-CSF; GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.; Other Names: NSC#617589

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft	at transplant (1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years

Collaborators and Investigators

• Sponsor: Emory University

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): September 14, 2012
• Last Update Submitted That Met QC Criteria: August 17, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Hematologic Diseases
• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: 0693-2002