Hematologic Diseases
Conditions
Keywords
Hematologic Diseases
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.
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.
Interventions
DRUGG-CSF
G-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
DRUGGM-CSF
GM-CSF, solution given subcutaneously twice per day, total dosage varies by weight.
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft | at transplant (1 day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| G-CSF (Granulocyte Colony- Stimulating Factor) Single use of G-CSF | 25 |
| G-CSF and GM-CSF (Granulocyte Macrophage) Combined use of G-CSF and GM-CSF | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | G-CSF and GM-CSF (Granulocyte Macrophage) | G-CSF (Granulocyte Colony- Stimulating Factor) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 23 Participants | 45 Participants |
| Age, Customized | 53 years | 43 years | 49 years |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 25 | 25 / 25 |
| serious Total, serious adverse events | 7 / 25 | 7 / 25 |
Outcome results
Primary
Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft
Time frame: at transplant (1 day)
Population: 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 | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| G-CSF (Granulocyte Colony- Stimulating Factor) | Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft | 4 x10 ^ 6 cells/kg | Standard Error 1 |
| G-CSF and GM-CSF (Granulocyte Macrophage) | Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft | 2.5 x10 ^ 6 cells/kg | Standard Error 1 |
Secondary
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.
Median overall survival
Time frame: 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| G-CSF (Granulocyte Colony- Stimulating Factor) | 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. | 38.3 months |
| G-CSF and GM-CSF (Granulocyte Macrophage) | 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. | 7.3 months |