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

• Sponsor: Emory University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00208949
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 116
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Diseases	Drug: G-CSF; Drug: GM-CSF	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2002
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft [at transplant (1 day)]

Secondary Outcome Measures

1. 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. [5 years]

   Median overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sagar Lonial, MD, Emory University
• ClinicalTrials.gov Identifier: NCT00208949
• Other Study ID Numbers: 0693-2002
• First Posted: Sep 21, 2005
• Last Update Posted: Sep 14, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Sagar Lonial, MD, Emory University: Hematologic Diseases
• Additional relevant MeSH terms: Hematologic Diseases

Study Results

Participant Flow

Arm/Group Title	G-CSF (Granulocyte Colony- Stimulating Factor)	G-CSF and GM-CSF (Granulocyte Macrophage)
Arm/Group Description	Single use of G-CSF	Combined use of G-CSF and GM-CSF
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	G-CSF (Granulocyte Colony- Stimulating Factor)	G-CSF and GM-CSF (Granulocyte Macrophage)	Total
Arm/Group Description	Single use of G-CSF	Combined use of G-CSF and GM-CSF	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	23 92%	22 88%	45 90%
>=65 years	2 8%	3 12%	5 10%
Age, Customized (years) [Median (Full Range) ]
Median (Full Range) [years]	43	53	49
Sex: Female, Male (Count of Participants)
Female	10 40%	14 56%	24 48%
Male	15 60%	11 44%	26 52%
Region of Enrollment (participants) [Number]
United States	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Sample size determinations for this randomized trial were based on a baseline frequency of mDCs(myeloid dendritic cells) and pDCs( plasmacytoid dendritic cells)within the peripheral blood of 0.5% with a SD equal to the mean (0.5%).

Arm/Group Title	G-CSF (Granulocyte Colony- Stimulating Factor)	G-CSF and GM-CSF (Granulocyte Macrophage)
Arm/Group Description	Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day	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.)
Measure Participants	25	25
Median (Standard Error) [x10 ^ 6 cells/kg]	4 (1)	2.5 (1)

2. Secondary Outcome

Title	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.
Description	Median overall survival
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	G-CSF (Granulocyte Colony- Stimulating Factor)	G-CSF and GM-CSF (Granulocyte Macrophage)
Arm/Group Description	Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day	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.)
Measure Participants	25	25
Median (Full Range) [months]	38.3	7.3

Adverse Events

Arm/Group Title	G-CSF (Granulocyte Colony- Stimulating Factor)		G-CSF and GM-CSF (Granulocyte Macrophage)
Arm/Group Description	Single use of G-CSF		Combined use of G-CSF and GM-CSF
All Cause Mortality
	G-CSF (Granulocyte Colony- Stimulating Factor)		G-CSF and GM-CSF (Granulocyte Macrophage)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	G-CSF (Granulocyte Colony- Stimulating Factor)		G-CSF and GM-CSF (Granulocyte Macrophage)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/25 (28%)		7/25 (28%)
Blood and lymphatic system disorders
Death	7/25 (28%)		7/25 (28%)
Other (Not Including Serious) Adverse Events
	G-CSF (Granulocyte Colony- Stimulating Factor)		G-CSF and GM-CSF (Granulocyte Macrophage)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/25 (68%)		25/25 (100%)
General disorders
Fever	2/25 (8%)		9/25 (36%)
Musculoskeletal and connective tissue disorders
Bone Pain	12/25 (48%)		19/25 (76%)
Injected site pain	2/25 (8%)		5/25 (20%)
Skin and subcutaneous tissue disorders
Injection site redness	1/25 (4%)		3/25 (12%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.