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

Emory University

Status and phase: Terminated; Phase 2

Conditions: Hematologic Diseases

Treatments: Drug: GM-CSF; Drug: G-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT00208949

0693-2002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

G-CSF(Granulocyte Colony-Stimulating Factor )

Active Comparator group

Description:

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

Treatment:

Drug: G-CSF

Granulocyte CSF+Granulocyte Macrophage CSF

Active Comparator group

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.)

Treatment:

Drug: G-CSF

Drug: GM-CSF