Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489281
Status:
TERMINATED
Last Update Posted:
2019-04-17
First Post:
2007-06-20
Brief Title:
Non-Myeloablative Bone Marrow Transplant for Patients With Sickle Cell Anemia and Other Blood Disorders
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched and HLA-Matched Bone Marrow for Patients With Sickle Cell Anemia and Other Hemoglobinopathies
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Initiation of CMS BMT study for sickle-cell disease operating under NCT01166009 made further accrual to this study impossible
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 fludarabine and cyclophosphamide and total-body irradiation before a donor bone marrow transplant helps stop the growth of abnormal cells It also helps stop the patients immune system from rejecting the donors stem cells When the healthy stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving sirolimus and mycophenolate mofetil after transplant may stop this from happening
PURPOSE This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by a donor bone marrow transplant works in treating patients with sickle cell anemia and other blood disorders
PURPOSE This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by a donor bone marrow transplant works in treating patients with sickle cell anemia and other blood disorders
Detailed Description:
OBJECTIVES
Determine the transplant-related mortality and progression-free survival of patients with severe hemoglobinopathies receiving nonmyeloablative conditioning comprising fludarabine phosphate cyclophosphamide and total-body irradiation followed by partially HLA-mismatched bone marrow transplantation from first-degree relatives or HLA-matched donors
Characterize donor hematopoietic chimerism at 30 60 and 180 days after transplantation in these patients
Determine the hematologic and non-hematologic toxicity of this regimen in these patients
OUTLINE
Preparative regimen Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -6 and -5 Patients also undergo total-body irradiation on day -1
Bone marrow transplantation Patients undergo allogeneic bone marrow transplantation on day 0 Patients then receive cyclophosphamide IV over 1-2 hours on days 3 and 4
Graft-versus-host disease prophylaxis Patients receive sirolimus orally daily on days 5-365 and oral mycophenolate mofetil 3 times a day on days 5-35
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Determine the transplant-related mortality and progression-free survival of patients with severe hemoglobinopathies receiving nonmyeloablative conditioning comprising fludarabine phosphate cyclophosphamide and total-body irradiation followed by partially HLA-mismatched bone marrow transplantation from first-degree relatives or HLA-matched donors
Characterize donor hematopoietic chimerism at 30 60 and 180 days after transplantation in these patients
Determine the hematologic and non-hematologic toxicity of this regimen in these patients
OUTLINE
Preparative regimen Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1-2 hours on days -6 and -5 Patients also undergo total-body irradiation on day -1
Bone marrow transplantation Patients undergo allogeneic bone marrow transplantation on day 0 Patients then receive cyclophosphamide IV over 1-2 hours on days 3 and 4
Graft-versus-host disease prophylaxis Patients receive sirolimus orally daily on days 5-365 and oral mycophenolate mofetil 3 times a day on days 5-35
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 50 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 |
|---|---|---|---|
| NA_00002479 | OTHER | JHMIRB | httpsreporternihgovquickSearchP01CA015396 |
| P30CA006973 | NIH | None | None |
| P01CA015396 | NIH | None | None |