Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118326
Status:
COMPLETED
Last Update Posted:
2010-05-14
First Post:
2005-07-08
Brief Title:
Donor Bone Marrow Transplant in Treating Young Patients With Cancer or a Non-Cancerous Disease
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Feasibility of Granulocyte-Colony Stimulating Factor G-CSF Stimulated Bone Marrow From Pediatric Donors as a Stem Cell Source for Allogeneic Bone Marrow Transplant
Status:
COMPLETED
Status Verified Date:
2010-05
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 A bone marrow transplant from a brother or sister may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy Colony-stimulating factors such as G-CSF cause the body to make blood cells Giving G-CSF to the donor may help the body make more stem cells that can be collected for bone marrow transplant and may cause fewer side effects in the patient after the transplant
PURPOSE This phase III trial is studying the side effects of donor bone marrow transplant and to see how well it works in treating young patients with cancer or a non-cancerous disease
PURPOSE This phase III trial is studying the side effects of donor bone marrow transplant and to see how well it works in treating young patients with cancer or a non-cancerous disease
Detailed Description:
OBJECTIVES
Primary
Determine the safety and feasibility of filgrastim G-CSF-mobilized bone marrow from an HLA-identical pediatric sibling donor as a stem cell source for pediatric patients undergoing allogeneic bone marrow transplantation for malignant or non-malignant disease
Secondary
Determine the time to neutrophil and platelet engraftment number of red blood cell and platelet transfusions number of febrile days and number of hospitalization days in patients treated with this regimen
Determine the number of nucleated cells and CD34-positive cells absolute lymphocyte count and lymphocyte subsets CD3CD4CD8 in G-CSF-mobilized bone marrow from these donors
OUTLINE This is a multicenter pilot study
Donors receive filgrastim G-CSF subcutaneously once daily on days -4 to 0 Donors then undergo standard bone marrow harvest on day 0
Patients receive pre-transplantation conditioning and graft-versus-host disease prophylaxis according to the disease for which the patient is being treated and the treatment plan or clinical trial for which the patient is enrolled on Patients undergo allogeneic bone marrow transplantation on day 0
After completion of bone marrow harvest donors are followed at 7 and 30 days After completion of study treatment patients are followed for 100 days post-transplantation and then periodically thereafter
PROJECTED ACCRUAL A total of 80 participants 40 donors and 40 patients will be accrued for this study within 18 months
Primary
Determine the safety and feasibility of filgrastim G-CSF-mobilized bone marrow from an HLA-identical pediatric sibling donor as a stem cell source for pediatric patients undergoing allogeneic bone marrow transplantation for malignant or non-malignant disease
Secondary
Determine the time to neutrophil and platelet engraftment number of red blood cell and platelet transfusions number of febrile days and number of hospitalization days in patients treated with this regimen
Determine the number of nucleated cells and CD34-positive cells absolute lymphocyte count and lymphocyte subsets CD3CD4CD8 in G-CSF-mobilized bone marrow from these donors
OUTLINE This is a multicenter pilot study
Donors receive filgrastim G-CSF subcutaneously once daily on days -4 to 0 Donors then undergo standard bone marrow harvest on day 0
Patients receive pre-transplantation conditioning and graft-versus-host disease prophylaxis according to the disease for which the patient is being treated and the treatment plan or clinical trial for which the patient is enrolled on Patients undergo allogeneic bone marrow transplantation on day 0
After completion of bone marrow harvest donors are followed at 7 and 30 days After completion of study treatment patients are followed for 100 days post-transplantation and then periodically thereafter
PROJECTED ACCRUAL A total of 80 participants 40 donors and 40 patients will be accrued for this study within 18 months
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 |
|---|---|---|---|
| CDR0000430709 | REGISTRY | PDQ | None |
| FHCRC-180200 | None | None | None |
| PBMTC-STC0233 | None | None | None |