Cytokines
Conditions
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.
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.
Interventions
DRUGG-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.
DRUGG-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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Total Number of CD34+ Cells Collected. | 4 days | — |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Days of Apheresis | 7 days | the number of days of apheresis required to collect target numbers of CD34+ cells. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abdomen These subjects will have their cytokine injections administered only to their abdomen. | 18 |
| Extremities The extremity arm will have their injections administered to their upper and/or lower extremities. | 17 |
| Total | 35 |
Baseline characteristics
| Characteristic | Extremities | Total | Abdomen |
|---|---|---|---|
| Age, Customized | 52 Mean STANDARD_DEVIATION 17.02 | 53 Mean STANDARD_DEVIATION 15.21 | 53 Mean STANDARD_DEVIATION 13.76 |
| Disease type Lymphoma | 6 participants | 10 participants | 4 participants |
| Disease type Myeloma | 11 participants | 25 participants | 14 participants |
| Region of Enrollment United States | 17 participants | 35 participants | 18 participants |
| Sex: Female, Male Female | 7 Participants | 17 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 18 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 18 | 17 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
Primary
Number of Participants for Whom Target Number of CD34+ Cells Were Collected.
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abdomen | Number of Participants for Whom Target Number of CD34+ Cells Were Collected. | 10 participants |
| Extremities | Number of Participants for Whom Target Number of CD34+ Cells Were Collected. | 9 participants |
Primary
The Total Number of CD34+ Cells Collected.
Time frame: 4 days
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Abdomen | The Total Number of CD34+ Cells Collected. | 9,150,000 cells per Kg |
| Extremities | The Total Number of CD34+ Cells Collected. | 9,850,000 cells per Kg |
Secondary
Total Number of Days of Apheresis
the number of days of apheresis required to collect target numbers of CD34+ cells.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abdomen | Total Number of Days of Apheresis | 2.18 days | Standard Deviation 1.01 |
| Extremities | Total Number of Days of Apheresis | 2.00 days | Standard Deviation 0.97 |