Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002809
Status:
COMPLETED
Last Update Posted:
2010-10-01
First Post:
1999-11-01
Brief Title:
Bone Marrow Transplant Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States
Status:
COMPLETED
Status Verified Date:
2010-09
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells Combining chemotherapy and radiation therapy together with bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE This phase II trial is studying how well giving bone marrow transplant from an unrelated donor together with cyclophosphamide and total-body irradiation works in treating patients with hematologic cancer
PURPOSE This phase II trial is studying how well giving bone marrow transplant from an unrelated donor together with cyclophosphamide and total-body irradiation works in treating patients with hematologic cancer
Detailed Description:
OBJECTIVES
Study the curative potential of high-dose cyclophosphamide and total-body irradiation followed by rescue with bone marrow from volunteer HLA-matched donors in patients with a variety of hematologic malignancies and bone marrow failure states
Study the toxic effects associated with matched unrelated bone marrow transplantation in this patient population
Participate in collaborative research studies with the National Marrow Donor Program
OUTLINE All patients receive myeloablative therapy with high-dose cyclophosphamide and total body irradiation over 4 days patients with severe aplastic anemia also receive antithymocyte globulin Patients then undergo allogeneic bone marrow transplantation Filgrastim G-CSF is given after transplant to accelerate engraftment Sargramostim GM-CSF may be given in case of graft failure
All patients receive graft-versus-host-disease GVHD prophylaxis with tacrolimus methotrexate and gamma globulin Established GVHD is treated with corticosteroids and as necessary antithymocyte globulin
Patients are followed at 100 days 6 months and 1 year after transplant then annually thereafter
PROJECTED ACCRUAL A total of 10 patients per year will be accrued for this study over 5 years
Study the curative potential of high-dose cyclophosphamide and total-body irradiation followed by rescue with bone marrow from volunteer HLA-matched donors in patients with a variety of hematologic malignancies and bone marrow failure states
Study the toxic effects associated with matched unrelated bone marrow transplantation in this patient population
Participate in collaborative research studies with the National Marrow Donor Program
OUTLINE All patients receive myeloablative therapy with high-dose cyclophosphamide and total body irradiation over 4 days patients with severe aplastic anemia also receive antithymocyte globulin Patients then undergo allogeneic bone marrow transplantation Filgrastim G-CSF is given after transplant to accelerate engraftment Sargramostim GM-CSF may be given in case of graft failure
All patients receive graft-versus-host-disease GVHD prophylaxis with tacrolimus methotrexate and gamma globulin Established GVHD is treated with corticosteroids and as necessary antithymocyte globulin
Patients are followed at 100 days 6 months and 1 year after transplant then annually thereafter
PROJECTED ACCRUAL A total of 10 patients per year will be accrued for this study over 5 years
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-V96-0950 | None | None | None |
| TUHSC-2803 | None | None | None |