Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006251
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2000-09-11
Brief Title:
Fludarabine Phosphate Low-Dose Total-Body Irradiation and Donor Stem Cell Transplant Followed by Cyclosporine Mycophenolate Mofetil Donor Lymphocyte Infusion in Treating Patients With Hematopoietic Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine Low Dose TBI PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil
Status:
COMPLETED
Status Verified Date:
2020-01
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 clinical trial studies fludarabine phosphate low-dose total-body irradiation and donor stem cell transplant followed by cyclosporine mycophenolate mofetil and donor lymphocyte infusion in treating patients with hematopoietic cancer Giving low doses of chemotherapy such as fludarabine phosphate and total body irradiation TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells It may also keep the patients immune response 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 Giving an infusion of the donors T cells donor lymphocyte infusion after the transplant may help increase this effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the risk of graft rejection associated with the addition of fludarabine fludarabine phosphate to a non-myeloablative conditioning regimen for patients with malignant diseases treatable by allogeneic stem cell transplantation and compare this rate to that observed among patients previously treated without fludarabine
II To estimate the rate of grade acute IIIV graft-vs-host disease GVHD and chronic GVHD in patients treated with low-dose total-body irradiation TBI fludarabine peripheral blood stem cell PBSC infusion and immunosuppression with cyclosporine and mycophenolate mofetil
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days - 4 to -2 and undergo low-dose TBI on day 0 Note Patients who have had an autologous transplant within 90 days prior to day 0 will not receive fludarabine phosphate
PBSC INFUSION Patients undergo allogeneic PBSC transplant on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 35 with a taper to day 56 Patients receive mycophenolate mofetil PO BID on days 0-27
POST TRANSPLANT DONOR LYMPHOCYTE INFUSION DLI Patients with stable mixed chimerism on day 56 and without evidence of GVHD undergo DLI IV over 30 minutes on day 65 Patients without a complete response full donor chimerism and GVHD after 2 months undergo further DLI at higher cell numbers Up to 6 DLIs may be given 65 days apart
After completion of study treatment patients are followed up at 4 6 12 18 and 24 months and then annually thereafter
I To estimate the risk of graft rejection associated with the addition of fludarabine fludarabine phosphate to a non-myeloablative conditioning regimen for patients with malignant diseases treatable by allogeneic stem cell transplantation and compare this rate to that observed among patients previously treated without fludarabine
II To estimate the rate of grade acute IIIV graft-vs-host disease GVHD and chronic GVHD in patients treated with low-dose total-body irradiation TBI fludarabine peripheral blood stem cell PBSC infusion and immunosuppression with cyclosporine and mycophenolate mofetil
OUTLINE
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days - 4 to -2 and undergo low-dose TBI on day 0 Note Patients who have had an autologous transplant within 90 days prior to day 0 will not receive fludarabine phosphate
PBSC INFUSION Patients undergo allogeneic PBSC transplant on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 35 with a taper to day 56 Patients receive mycophenolate mofetil PO BID on days 0-27
POST TRANSPLANT DONOR LYMPHOCYTE INFUSION DLI Patients with stable mixed chimerism on day 56 and without evidence of GVHD undergo DLI IV over 30 minutes on day 65 Patients without a complete response full donor chimerism and GVHD after 2 months undergo further DLI at higher cell numbers Up to 6 DLIs may be given 65 days apart
After completion of study treatment patients are followed up at 4 6 12 18 and 24 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 |
|---|---|---|---|
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2013-01634 | REGISTRY | None | None |
| 153300 | OTHER | None | None |
| P01CA078902 | NIH | None | None |