Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121186
Status:
TERMINATED
Last Update Posted:
2012-04-03
First Post:
2005-07-19
Brief Title:
S0501 Fludarabine Melphalan and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Nonmyeloablative Allogeneic Stem Cell Transplantation For Relapsed Hodgkins or Non-Hodgkins Lymphoma After Autologous Transplantation A BMT Study
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving low doses of chemotherapy such as fludarabine and melphalan before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells It also stops the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune system and help destroy any remaining cancer cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving tacrolimus and methotrexate after transplant may stop this from happening
PURPOSE This phase II trial is studying how well giving fludarabine together with melphalan followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor stem cell transplant for relapsed lymphoma
PURPOSE This phase II trial is studying how well giving fludarabine together with melphalan followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor stem cell transplant for relapsed lymphoma
Detailed Description:
OBJECTIVES
Determine the 1-year progression-free and overall survival rate in patients with relapsed Hodgkins or non-Hodgkins lymphoma after prior autologous stem cell transplantation treated with a nonmyeloablative conditioning regimen comprising fludarabine and melphalan followed by allogeneic bone marrow or peripheral blood stem cell transplantation and immunosuppression comprising tacrolimus and methotrexate
Determine treatment-related mortality in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine engraftment of donor hematopoietic stem cells as measured by hematopoietic recovery and donor-derived hematopoiesis determined by T cell and neutrophil specific chimerism at 2 3 6 and 12 months in patients treated with this regimen
Determine the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to diagnosis Hodgkins lymphoma vs non-Hodgkins lymphoma
Patients receive fludarabine IV over 1 hour on days -6 to -2 and melphalan IV over 15-20 minutes on days -3 and -2 Patients undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0 Patients receive oral tacrolimus twice daily beginning on day -3 and continuing until day 100 followed by a taper to day 180 Patients also receive methotrexate IV on days 1 3 and 7 Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study transplantation patients are followed at 1 and 3 months 1 year and then annually for up to 4 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 2 years
Determine the 1-year progression-free and overall survival rate in patients with relapsed Hodgkins or non-Hodgkins lymphoma after prior autologous stem cell transplantation treated with a nonmyeloablative conditioning regimen comprising fludarabine and melphalan followed by allogeneic bone marrow or peripheral blood stem cell transplantation and immunosuppression comprising tacrolimus and methotrexate
Determine treatment-related mortality in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine engraftment of donor hematopoietic stem cells as measured by hematopoietic recovery and donor-derived hematopoiesis determined by T cell and neutrophil specific chimerism at 2 3 6 and 12 months in patients treated with this regimen
Determine the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to diagnosis Hodgkins lymphoma vs non-Hodgkins lymphoma
Patients receive fludarabine IV over 1 hour on days -6 to -2 and melphalan IV over 15-20 minutes on days -3 and -2 Patients undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0 Patients receive oral tacrolimus twice daily beginning on day -3 and continuing until day 100 followed by a taper to day 180 Patients also receive methotrexate IV on days 1 3 and 7 Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study transplantation patients are followed at 1 and 3 months 1 year and then annually for up to 4 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0501 | OTHER | None | None |