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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Hematologic Diseases

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

at transplant (1 day)

Safety Issue:

No

Principal Investigator

Sagar Lonial, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

0693-2002

NCT ID:

NCT00208949

Start Date:

September 2002

Completion Date:

May 2012

Related Keywords:

  • Hematologic Diseases
  • Hematologic Diseases
  • Hematologic Diseases

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322