Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453388
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2007-03-27
Brief Title:
Fludarabine Phosphate Cyclophosphamide and Total-Body Irradiation Followed by Donor Bone Marrow Transplant Mycophenolate Mofetil and Cyclosporine in Treating Patients With Fanconi Anemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Nonmyeloablative Hematopoietic Cell Transplantation for Patients With Fanconi Anemia Using Alternative Marrow Donors A Phase II Dose-Finding Study
Status:
COMPLETED
Status Verified Date:
2019-12
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:
This phase II trial studies how well total-body irradiation TBI works when given together with fludarabine phosphate and cyclophosphamide followed by donor bone marrow transplant mycophenolate mofetil and cyclosporine in treating patients with Fanconi anemia FA Giving low doses of chemotherapy such as fludarabine phosphate and cyclophosphamide and TBI before or after a donor bone marrow transplant helps stop the growth of abnormal cells It may also stop the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune cells and help destroy any remaining cancer cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I Identify doses of total-body irradiation TBI that lead to sufficient probability of donor engraftment 5 donor cluster of differentiation CD3 chimerism by day 200
II Evaluate the probability of severe acute graft-versus-host disease
SECONDARY OBJECTIVES
I Evaluate the probabilities of overall survival regimen-related toxicity RRT and recurrent hematopoietic malignancy in those patients with a prior underlying history of such
II Examine the degree to which mixed chimerism provides for amelioration of symptoms ie infections due to neutropenia hemorrhage due to thrombocytopenia associated with bone marrow failure
III Determine if the FA complementation group and initial mosaicism predict engraftment and RRT outcomes
OUTLINE Patients are assigned to 1 of 4 treatment arms
NOTE Patients no longer receive pre-transplant cyclophosphamide as of February 2009
After completion of study treatment patients are followed up at 6 months and then annually thereafter
I Identify doses of total-body irradiation TBI that lead to sufficient probability of donor engraftment 5 donor cluster of differentiation CD3 chimerism by day 200
II Evaluate the probability of severe acute graft-versus-host disease
SECONDARY OBJECTIVES
I Evaluate the probabilities of overall survival regimen-related toxicity RRT and recurrent hematopoietic malignancy in those patients with a prior underlying history of such
II Examine the degree to which mixed chimerism provides for amelioration of symptoms ie infections due to neutropenia hemorrhage due to thrombocytopenia associated with bone marrow failure
III Determine if the FA complementation group and initial mosaicism predict engraftment and RRT outcomes
OUTLINE Patients are assigned to 1 of 4 treatment arms
NOTE Patients no longer receive pre-transplant cyclophosphamide as of February 2009
After completion of study treatment patients are followed up at 6 months and then annually thereafter
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 |
|---|---|---|---|
| NCI-2010-00238 | REGISTRY | None | None |
| 206400 | OTHER | None | None |
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |