Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027820
Status:
COMPLETED
Last Update Posted:
2019-12-20
First Post:
2001-12-07
Brief Title:
Total-Body Irradiation and Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Low-Dose TBI and Fludarabine Followed by Nonmyeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation Using Enhanced Postgrafting Immunosuppression for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial
Status:
COMPLETED
Status Verified Date:
2019-12
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 phase III trial studies whether a new kind of blood stem cell bone marrow transplant that may be less toxic is able to treat underlying blood cancer Stem cells are seed cells necessary to make blood cells Researchers want to see if using less radiation and less chemotherapy with new immune suppressing drugs will enable a stem cell transplant to work Researchers are hoping to see a mixture of recipient and donor stem cells after transplant This mixture of donor and recipient stem cells is called mixed-chimerism Researchers hope to see these donor cells eliminate tumor cells This is called a graft-versus-leukemia response
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether stable unrelated peripheral blood stem cell PBSC grafts can be safely established using nonmyeloablative pretransplant conditioning with intensified post-grafting immunosuppression and with every q 8 hours hr and possibly q 6 hr mycophenolate mofetil MMF dosing in patients with hematologic malignancies and renal cell carcinoma
II To determine if the incidence and severity of acute grades II-IV graft-versus-host disease GVHD can be reduced in patients with sustained engraftment with the use of q 8 hr MMF dosing
SECONDARY OBJECTIVES
I To determine if engraftment can be maintained in patients with low chimerism and high risk of rejection with the use of a single dose of fludarabine fludarabine phosphate followed by donor lymphocyte infusion DLI on continued MMFcyclosporine CSP
II To compare survival and disease free survival to those achieved under protocol 1463
OUTLINE
REDUCED-INTENSITY CONDITIONING Patients receive fludarabine phosphate intravenously IV on days -4 -3 and -2 and undergo total-body irradiation TBI on day 0
TRANSPLANT Patients undergo allogeneic peripheral blood stem cell transplant PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO every 8 hours on days 0-40 with taper to day 96
After completion of study treatment patients are followed up at 6 months 1 year 15 years 2 years and then annually thereafter
I To determine whether stable unrelated peripheral blood stem cell PBSC grafts can be safely established using nonmyeloablative pretransplant conditioning with intensified post-grafting immunosuppression and with every q 8 hours hr and possibly q 6 hr mycophenolate mofetil MMF dosing in patients with hematologic malignancies and renal cell carcinoma
II To determine if the incidence and severity of acute grades II-IV graft-versus-host disease GVHD can be reduced in patients with sustained engraftment with the use of q 8 hr MMF dosing
SECONDARY OBJECTIVES
I To determine if engraftment can be maintained in patients with low chimerism and high risk of rejection with the use of a single dose of fludarabine fludarabine phosphate followed by donor lymphocyte infusion DLI on continued MMFcyclosporine CSP
II To compare survival and disease free survival to those achieved under protocol 1463
OUTLINE
REDUCED-INTENSITY CONDITIONING Patients receive fludarabine phosphate intravenously IV on days -4 -3 and -2 and undergo total-body irradiation TBI on day 0
TRANSPLANT Patients undergo allogeneic peripheral blood stem cell transplant PBSCT on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO twice daily BID on days -3 to 100 with taper to day 177 and mycophenolate mofetil PO every 8 hours on days 0-40 with taper to day 96
After completion of study treatment patients are followed up at 6 months 1 year 15 years 2 years 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 |
|---|---|---|---|
| P01CA018029 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP01CA018029 |
| NCI-2012-00591 | REGISTRY | None | None |
| 164100 | OTHER | None | None |
| P30CA015704 | NIH | None | None |