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

Emory University

Status and phase: Terminated; Phase 2

Conditions: Cytokines

Treatments: Drug: G-CSF, GM-CSF administered at extremities; Drug: G-CSF and GMCSF administered at abdomen

Study type: Interventional

Funder types: Other

Identifiers

NCT00646763

IRB00007445

7445 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Abdomen

Active Comparator group

Description:

These subjects will have their cytokine injections administered only to their abdomen.

Treatment:

Drug: G-CSF and GMCSF administered at abdomen

Extremities

Active Comparator group

Description:

The extremity arm will have their injections administered to their upper and/or lower extremities.

Treatment:

Drug: G-CSF, GM-CSF administered at extremities