Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053157
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2003-01-27
Brief Title:
Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Use Of Granulocyte Macrophage Colony Stimulating Factor GM-CSF To Mobilize Donor Peripheral Blood Stem Cells Along With GM-CSF Administration Post Allogeneic Transplant - A Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy or radiation therapy Giving sargramostim to the stem cell donor and the patient may reduce the chance of developing graft-versus-host disease following stem cell transplantation
PURPOSE Clinical trial to study the effectiveness of sargramostim in decreasing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer or aplastic anemia
PURPOSE Clinical trial to study the effectiveness of sargramostim in decreasing graft-versus-host disease in patients who are undergoing donor stem cell transplantation for hematologic cancer or aplastic anemia
Detailed Description:
OBJECTIVES
Determine the efficacy of sargramostim GM-CSF to mobilize CD34 hematopoietic stem cells in donors and to reduce graft-vs-host disease in patients after allogeneic stem cell transplantation SCT for hematologic malignancy or aplastic anemia
Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients
OUTLINE This is a pilot study
Donors Donors receive sargramostim GM-CSF subcutaneously SC once daily on days 1-6 Donors undergo stem cell harvest on day 7
Donors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may receive additional GM-CSF prior to each collection
Patients Patients receive conditioning therapy as per transplantation protocol RP98-15 Patients undergo allogeneic stem cell transplantation on day 0 Patients then receive GM-CSF SC once daily beginning on day 7 and continuing until blood counts recover
Patients are followed weekly until day 100 and then at days 180 and 360
PROJECTED ACCRUAL A total of 10 patients and 10 donors will be accrued for this study
Determine the efficacy of sargramostim GM-CSF to mobilize CD34 hematopoietic stem cells in donors and to reduce graft-vs-host disease in patients after allogeneic stem cell transplantation SCT for hematologic malignancy or aplastic anemia
Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients
OUTLINE This is a pilot study
Donors Donors receive sargramostim GM-CSF subcutaneously SC once daily on days 1-6 Donors undergo stem cell harvest on day 7
Donors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may receive additional GM-CSF prior to each collection
Patients Patients receive conditioning therapy as per transplantation protocol RP98-15 Patients undergo allogeneic stem cell transplantation on day 0 Patients then receive GM-CSF SC once daily beginning on day 7 and continuing until blood counts recover
Patients are followed weekly until day 100 and then at days 180 and 360
PROJECTED ACCRUAL A total of 10 patients and 10 donors will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-RPC-0201 | None | None | None |