Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003572
Status:
COMPLETED
Last Update Posted:
2014-05-02
First Post:
1999-11-01
Brief Title:
Total-Body Irradiation Tacrolimus and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Non-Myeloablative Allogeneic Bone Marrow Transplant for Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2014-05
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 Radiation therapy uses high-energy x-rays to damage tumor cells Bone marrow transplantation may be able to replace immune cells that have been destroyed by radiation therapy used to kill tumor cells Sometimes the transplanted cells can make an immune response against the bodys normal tissues Mycophenolate mofetil and tacrolimus may be an effective treatment for graft-versus-host disease caused by bone marrow transplantation
PURPOSE Phase II trial to study the effectiveness of total-body irradiation tacrolimus and mycophenolate mofetil plus bone marrow transplantation in treating patients with hematologic cancers
PURPOSE Phase II trial to study the effectiveness of total-body irradiation tacrolimus and mycophenolate mofetil plus bone marrow transplantation in treating patients with hematologic cancers
Detailed Description:
OBJECTIVES I Determine whether sustained engraftment of HLA identical sibling marrow can be achieved in patients treated with total body irradiation before transplant and tacrolimus and mycophenolate mofetil after transplant II Document the nonhematologic toxicities of this regimen III Characterize immune reconstitution of patients during this treatment regimen IV Document the incidence of aplasia and graft-versus-host disease associated with donor leukocyte infusions when administered after this regimen
OUTLINE Patients receive total body irradiation in a single fraction on day -1 Tacrolimus is given orally twice per day on days -1 to 50 Mycophenolate mofetil is given orally on day 0 and twice per day on days 1 to 28 Patients receive donor bone marrow infusion on day 0 Patients are evaluated on days 56 180 292 and 365 If there is donor engraftment donor chimerism is less than 80 there is no active graft-versus-host disease no disease progression less than 50 decrease in donor cell chimerism from last measurement and the patient is not taking immunosuppressive agents then donor leukocyte infusions are administered on days 70 194 and 306 Patients are followed annually for 5 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
OUTLINE Patients receive total body irradiation in a single fraction on day -1 Tacrolimus is given orally twice per day on days -1 to 50 Mycophenolate mofetil is given orally on day 0 and twice per day on days 1 to 28 Patients receive donor bone marrow infusion on day 0 Patients are evaluated on days 56 180 292 and 365 If there is donor engraftment donor chimerism is less than 80 there is no active graft-versus-host disease no disease progression less than 50 decrease in donor cell chimerism from last measurement and the patient is not taking immunosuppressive agents then donor leukocyte infusions are administered on days 70 194 and 306 Patients are followed annually for 5 years
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| NCI-H98-0023 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| R01CA067782 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-98070603 | None | None | None |
| JHOC-9845 | None | None | None |