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

NCT ID: NCT00208949

Last Updated: 2012-09-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2012-05-31

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.

Conditions

Hematologic Diseases

Keywords

Hematologic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

G-CSF(Granulocyte Colony-Stimulating Factor )

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

Group Type: ACTIVE_COMPARATOR

G-CSF

Intervention Type: DRUG

G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.

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.)

Group Type: ACTIVE_COMPARATOR

G-CSF

Intervention Type: DRUG

G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.

GM-CSF

Intervention Type: DRUG

GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.

Interventions

G-CSF

G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.

Intervention Type: DRUG

GM-CSF

GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.

Intervention Type: DRUG

Other Intervention Names

Rhu; NSC#617589

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Sagar Lonial

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sagar Lonial, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Winship Cancer Institute

Locations

Emory University Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

0693-2002

Identifier Type: -

Identifier Source: org_study_id