A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation

• Sponsor: Emory University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00646763
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.

Condition or Disease	Intervention/Treatment	Phase
Cytokines	Drug: G-CSF, GM-CSF administered at extremities; Drug: G-CSF and GMCSF administered at abdomen	Phase 2

Detailed Description

The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood.

Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Single Institution Randomized Study Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients Undergoing Autologous Hematopoietic Progenitor Cell Transplant
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Abdomen These subjects will have their cytokine injections administered only to their abdomen.	Drug: G-CSF and GMCSF administered at abdomen; Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete.; Other Names: Neupogen, Leukine, growth factors
Active Comparator: Extremities The extremity arm will have their injections administered to their upper and/or lower extremities.	Drug: G-CSF, GM-CSF administered at extremities; Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete.; Other Names: Neupogen, Leukine, growth factors

Outcome Measures

Primary Outcome Measures

1. The Total Number of CD34+ Cells Collected. [4 days]

2. Number of Participants for Whom Target Number of CD34+ Cells Were Collected. [7 days]

   Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment

Secondary Outcome Measures

1. Total Number of Days of Apheresis [7 days]

   the number of days of apheresis required to collect target numbers of CD34+ cells.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with myeloma. All patients must meet criteria for transplantation.

Exclusion Criteria:

• Patients with active, invasive/systemic fungal infection.

• Patients who are pregnant or lactating females.

• Patients with active CNS malignant disease or life expectancy limited by diseases other than the disease for which the patient is being transplanted.

• Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.

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: Edmund Waller, MD, Emory University Winship Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Edmund Waller, Principal Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT00646763
• Other Study ID Numbers: IRB00007445; 7445
• First Posted: Mar 28, 2008
• Last Update Posted: Dec 20, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Lenograstim; Sargramostim; Mitogens

Study Results

Participant Flow

Arm/Group Title	Abdomen	Extremities
Arm/Group Description	These subjects will have their cytokine injections administered only to their abdomen.	The extremity arm will have their injections administered to their upper and/or lower extremities.
Period Title: Overall Study
STARTED	18	17
COMPLETED	18	17
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Abdomen	Extremities	Total
Arm/Group Description	These subjects will have their cytokine injections administered only to their abdomen.	The extremity arm will have their injections administered to their upper and/or lower extremities.	Total of all reporting groups
Overall Participants	18	17	35
Age, Customized (Mean) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Mean]	53 (13.76)	52 (17.02)	53 (15.21)
Sex: Female, Male (Count of Participants)
Female	10 55.6%	7 41.2%	17 48.6%
Male	8 44.4%	10 58.8%	18 51.4%
Region of Enrollment (participants) [Number]
United States	18 100%	17 100%	35 100%
Disease type (participants) [Number]
Lymphoma	4 22.2%	6 35.3%	10 28.6%
Myeloma	14 77.8%	11 64.7%	25 71.4%

Outcome Measures

1. Primary Outcome

Title	The Total Number of CD34+ Cells Collected.
Time Frame	4 days

Outcome Measure Data

Analysis Population Description

Patients at our institution between the ages of 18 and 70 years old with relapsed or refractory Hodgkin's disease, non-Hodgkin's lymphoma, or mutiple myelomawhowere scheduled for an autologous HSCTwere eligible to participate in the study.

Arm/Group Title	Abdomen	Extremities
Arm/Group Description	These subjects will have their cytokine injections administered only to their abdomen.	The extremity arm will have their injections administered to their upper and/or lower extremities.
Measure Participants	18	17
Mean (Standard Deviation) [cells per Kg]	9.15*10^6 (4.7*10^6)	9.85*10^6 (4.97*10^6)

2. Secondary Outcome

Title	Total Number of Days of Apheresis
Description	the number of days of apheresis required to collect target numbers of CD34+ cells.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abdomen	Extremities
Arm/Group Description	These subjects will have their cytokine injections administered only to their abdomen.	The extremity arm will have their injections administered to their upper and/or lower extremities.
Measure Participants	18	17
Mean (Standard Deviation) [days]	2.18 (1.01)	2.00 (0.97)

3. Primary Outcome

Title	Number of Participants for Whom Target Number of CD34+ Cells Were Collected.
Description	Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abdomen	Extremities
Arm/Group Description	These subjects will have their cytokine injections administered only to their abdomen.	The extremity arm will have their injections administered to their upper and/or lower extremities.
Measure Participants	18	17
Number [participants]	10 55.6%	9 52.9%

Adverse Events

Arm/Group Title	Abdomen		Extremities
Arm/Group Description	These subjects will have their cytokine injections administered only to their abdomen.		The extremity arm will have their injections administered to their upper and/or lower extremities.
All Cause Mortality
	Abdomen		Extremities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Abdomen		Extremities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Abdomen		Extremities
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/18 (100%)		17/17 (100%)
Musculoskeletal and connective tissue disorders
Bone Pain	18/18 (100%)		17/17 (100%)
Skin and subcutaneous tissue disorders
Redness at the injection site	18/18 (100%)		17/17 (100%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.