Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317876
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2006-04-24
Brief Title:
Cyclophosphamide in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Fanconis Anemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Dose-Finding Study for Cyclophosphamide as Conditioning Regimens for Bone Marrow Transplantation From Related Donors in Patients With Fanconi Anemia
Status:
COMPLETED
Status Verified Date:
2012-04
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 Giving low doses of chemotherapy such as cyclophosphamide before a donor bone marrow transplant helps stop the growth of abnormal cells It also stops the patients immune system from rejecting the donors bone marrow The donated bone marrow stem cells may replace the patients immune system and help destroy any remaining abnormal cells Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine and methotrexate before or after transplant may stop this from happening
PURPOSE This phase I trial is studying the side effects and best dose of cyclophosphamide in treating patients who are undergoing a donor bone marrow transplant for Fanconis anemia
PURPOSE This phase I trial is studying the side effects and best dose of cyclophosphamide in treating patients who are undergoing a donor bone marrow transplant for Fanconis anemia
Detailed Description:
OBJECTIVES
Decrease the conditioning-related toxicity of cyclophosphamide without decreasing the engraftment rate to 90 in patients undergoing allogeneic bone marrow transplantation for Fanconis anemia
OUTLINE This is a multicenter dose-finding study of cyclophosphamide
Nonmyeloablative conditioning regimen Patients receive cyclophosphamide IV on days -5 to -2
Cohorts of 5-10 patients receive decreasing doses of cyclophosphamide until the optimal dose OD is determined The OD is defined as the dose at which 4 of 5 patients achieve engraftment and 1 of 10 patients experiences dose-limiting toxicity
Allogeneic bone marrow transplantation BMT Patients undergo allogeneic BMT on day 0
Graft-vs-host-disease GVHD prophylaxis Patients receive cyclosporine orally or IV twice daily beginning on day -1 and continuing until day 49 followed by a taper on days 50-180 in the absence of GVHD Patients also receive methotrexate IV on days 1 3 6 and 11
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
Decrease the conditioning-related toxicity of cyclophosphamide without decreasing the engraftment rate to 90 in patients undergoing allogeneic bone marrow transplantation for Fanconis anemia
OUTLINE This is a multicenter dose-finding study of cyclophosphamide
Nonmyeloablative conditioning regimen Patients receive cyclophosphamide IV on days -5 to -2
Cohorts of 5-10 patients receive decreasing doses of cyclophosphamide until the optimal dose OD is determined The OD is defined as the dose at which 4 of 5 patients achieve engraftment and 1 of 10 patients experiences dose-limiting toxicity
Allogeneic bone marrow transplantation BMT Patients undergo allogeneic BMT on day 0
Graft-vs-host-disease GVHD prophylaxis Patients receive cyclosporine orally or IV twice daily beginning on day -1 and continuing until day 49 followed by a taper on days 50-180 in the absence of GVHD Patients also receive methotrexate IV on days 1 3 6 and 11
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 27 patients 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 |
|---|---|---|---|
| FHCRC-128800 | None | None | None |
| CDR0000481264 | REGISTRY | PDQ | None |