Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00119392
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2005-07-12
Brief Title:
Yttrium Y 90 Ibritumomab Tiuxetan Fludarabine Radiation Therapy and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan Anti-CD20 Antibody With Fludarabine Low-Dose Total Body Irradiation TBI and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-06
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:
Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan can block find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells Giving monoclonal antibodies low doses of chemotherapy such as fludarabine phosphate and low dose total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells and also stops the patients immune system 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 Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine or mycophenolate mofetil after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To assess the feasibility safety and potential efficacy of treating patients with B-Cell non-Hodgkin lymphoma NHL with 90Y-ibritumomab tiuxetan combined with HLA-matched related or unrelated donor hematopoietic cell transplantation
OUTLINE Patients receive rituximab intravenously IV followed by no more than 4 hours later indium In 111 ibritumomab tiuxetan for imaging IV over 10 minutes on day -21 Patients undergo gamma camera imaging on day -19 Patients receive rituximab IV followed by no more than 4 hours later yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14 Patients also receive fludarabine phosphate IV over 30-60 minutes on days -7 to -5 and undergo low-dose total-body irradiation TBI on day 0 After TBI patients undergo allogeneic peripheral blood stem cell transplantation PBSCT on day 0 Patients who undergo PBSCT from a related donor receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease GVHD These patients also receive oral mycophenolate mofetil twice daily on days 0 to 27 Patients who undergo PBSCT from an unrelated donor receive oral cyclosporine twice daily on days -3 to 100 followed by a taper over 11 weeks in the absence of GVHD These patients also receive oral mycophenolate mofetil three times daily on days 0 to 40 followed by a taper to day 96
After completion of study treatment patients are followed up at 1 3 6 and 12 months and then annually thereafter
I To assess the feasibility safety and potential efficacy of treating patients with B-Cell non-Hodgkin lymphoma NHL with 90Y-ibritumomab tiuxetan combined with HLA-matched related or unrelated donor hematopoietic cell transplantation
OUTLINE Patients receive rituximab intravenously IV followed by no more than 4 hours later indium In 111 ibritumomab tiuxetan for imaging IV over 10 minutes on day -21 Patients undergo gamma camera imaging on day -19 Patients receive rituximab IV followed by no more than 4 hours later yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14 Patients also receive fludarabine phosphate IV over 30-60 minutes on days -7 to -5 and undergo low-dose total-body irradiation TBI on day 0 After TBI patients undergo allogeneic peripheral blood stem cell transplantation PBSCT on day 0 Patients who undergo PBSCT from a related donor receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease GVHD These patients also receive oral mycophenolate mofetil twice daily on days 0 to 27 Patients who undergo PBSCT from an unrelated donor receive oral cyclosporine twice daily on days -3 to 100 followed by a taper over 11 weeks in the absence of GVHD These patients also receive oral mycophenolate mofetil three times daily on days 0 to 40 followed by a taper to day 96
After completion of study treatment patients are followed up at 1 3 6 and 12 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 |
|---|---|---|---|
| NCI-2010-01381 | REGISTRY | CTRP Clinical Trial Reporting Program | None |