Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014235
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2001-04-10
Brief Title:
Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic Malignancies
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Nonmyeloablative PBSC Allografting From HLA Matched Related Donors Using Fludarabine andor Low Dose TBI With Disease-Risk Based Immunosuppression
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 and total-body radiation followed by donor peripheral blood stem cell transplant and immunosuppression in treating patients with hematologic malignancies Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells It may also 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 total-body irradiation together with fludarabine phosphate cyclosporine and mycophenolate mofetil before transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the rate of grade IIIIV graft-versus-host disease GVHD in patients treated with low-dose total body irradiation TBI fludarabine fludarabine phosphate PBSC infusion and immunosuppression with mycophenolate mofetil and a disease risk-based cyclosporine taper
II To estimate the risk of graft rejection GVHD disease response non-relapse mortality and the incidence and severity of infectious complications using this treatment strategy
OUTLINE Patients are assigned to 1 of 2 treatment groups
ARM I indolent disease
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo TBI on day 0
TRANSPLANTATION Patients undergo donor peripheral blood stem cell transplantation PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID or IV every 8-12 hours on days -3 to 56 with a taper to day 180 and mycophenolate mofetil PO BID or IV every 8-12 hours on days 0 to 27
ARM II aggressive disease
CONDITIONING REGIMEN Patients receive fludarabine phosphate and undergo TBI as in Arm I
TRANSPLANTATION Patients undergo donor PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine PO BID or IV every 8-12 hours on days -3 to 56 with a taper to day 70 and mycophenolate mofetil as in Arm I
After completion of study treatment patients are followed up for 5 years
I To estimate the rate of grade IIIIV graft-versus-host disease GVHD in patients treated with low-dose total body irradiation TBI fludarabine fludarabine phosphate PBSC infusion and immunosuppression with mycophenolate mofetil and a disease risk-based cyclosporine taper
II To estimate the risk of graft rejection GVHD disease response non-relapse mortality and the incidence and severity of infectious complications using this treatment strategy
OUTLINE Patients are assigned to 1 of 2 treatment groups
ARM I indolent disease
CONDITIONING REGIMEN Patients receive fludarabine phosphate intravenously IV on days -4 to -2 and undergo TBI on day 0
TRANSPLANTATION Patients undergo donor peripheral blood stem cell transplantation PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID or IV every 8-12 hours on days -3 to 56 with a taper to day 180 and mycophenolate mofetil PO BID or IV every 8-12 hours on days 0 to 27
ARM II aggressive disease
CONDITIONING REGIMEN Patients receive fludarabine phosphate and undergo TBI as in Arm I
TRANSPLANTATION Patients undergo donor PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine PO BID or IV every 8-12 hours on days -3 to 56 with a taper to day 70 and mycophenolate mofetil as in Arm I
After completion of study treatment patients are followed up for 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-2012-00671 | REGISTRY | None | None |
| 159600 | OTHER | None | None |
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |