Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003414
Status:
COMPLETED
Last Update Posted:
2015-07-20
First Post:
1999-11-01
Brief Title:
Graft-Versus-Host Disease in Treating Patients With Recurrent or Refractory Lymphoma or Hodgkins Disease
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Randomized Trial of Autologous GVHD for Refractory Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-07
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 Cyclosporine may induce graft-versus-host disease and make the body build an immune response that will kill cancer cells Interleukin-2 and interferon gamma may enhance the effectiveness of graft-versus-host disease to kill cancer cells
PURPOSE Randomized phase III trial to determine the effectiveness of graft-versus-host disease in treating patients who have recurrent or refractory lymphoma or Hodgkins disease
PURPOSE Randomized phase III trial to determine the effectiveness of graft-versus-host disease in treating patients who have recurrent or refractory lymphoma or Hodgkins disease
Detailed Description:
OBJECTIVES I Determine whether autologous graft versus host disease significantly alters the relapse rate for lymphoma or Hodgkins disease after autologous bone marrow transplantation
OUTLINE This is a randomized study Stem cells are harvested and cryopreserved All patients receive busulfancyclophosphamide or cyclosporinetotal body irradiation as a preparative regimen Arm I Patients randomized to the graft versus host disease GVHD induction arm receive oral cyclosporine twice a day beginning on day 0 and continuing for at least 28 days followed by peripheral blood stem cell PBSC infusion At the time the white blood cell count begins to recover subcutaneous interferon gamma is administered for 10 doses followed 2 days later by subcutaneous interleukin-2 IL-2 for 18 doses Arm II Patients do not receive autologous GVHD therapy after the PBSC transplant Both arms should receive radiation to the site of lymphoma after recovering from the stem cell transplantation Patients are followed at 6 months 1 year and 2 years posttransplant
PROJECTED ACCRUAL Approximately 50 patients 25 per arm will be accrued for this study within 3 years
OUTLINE This is a randomized study Stem cells are harvested and cryopreserved All patients receive busulfancyclophosphamide or cyclosporinetotal body irradiation as a preparative regimen Arm I Patients randomized to the graft versus host disease GVHD induction arm receive oral cyclosporine twice a day beginning on day 0 and continuing for at least 28 days followed by peripheral blood stem cell PBSC infusion At the time the white blood cell count begins to recover subcutaneous interferon gamma is administered for 10 doses followed 2 days later by subcutaneous interleukin-2 IL-2 for 18 doses Arm II Patients do not receive autologous GVHD therapy after the PBSC transplant Both arms should receive radiation to the site of lymphoma after recovering from the stem cell transplantation Patients are followed at 6 months 1 year and 2 years posttransplant
PROJECTED ACCRUAL Approximately 50 patients 25 per arm will be accrued for this study within 3 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-V98-1453 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA015396 |
| P30CA006973 | NIH | None | None |
| P01CA015396 | NIH | None | None |
| JHOC-97080106 | None | None | None |
| JHOC-9726 | None | None | None |