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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

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Sagar Lonial, Emory University
ClinicalTrials.gov Identifier:
NCT00208949
First received: September 13, 2005
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Hematologic Diseases
Drug: G-CSF
Drug: GM-CSF
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft [ Time Frame: at transplant (1 day) ] [ Designated as safety issue: No ]

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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Median overall survival


Enrollment: 50
Study Start Date: September 2002
Study Completion Date: May 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Rhu
Drug: GM-CSF
GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
Other Name: NSC#617589

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208949

Locations
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Sagar Lonial, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Sagar Lonial, MD, Emory University
ClinicalTrials.gov Identifier: NCT00208949     History of Changes
Other Study ID Numbers: 0693-2002
Study First Received: September 13, 2005
Results First Received: March 22, 2012
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Emory University:
Hematologic Diseases

Additional relevant MeSH terms:
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014