Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416884
Status:
TERMINATED
Last Update Posted:
2017-09-27
First Post:
2006-12-27
Brief Title:
FluAlemtuzumaband TBI Followed By Donor Stem Cell Chronic Phase CML
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Fludarabine Campath TBI T-Cell Deplete NMSCT With Post-Transplant T-Cell Infusions for CML Failing Imatinib Therapy With Imatinib STI571
Status:
TERMINATED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
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 total-body irradiation TBI before a donor 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 Giving an infusion of the donors T cells donor lymphocyte infusion that have been treated in the laboratory 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 alemtuzumab and removing the T lymphocyte cellsT cells from the donor cells before transplant may stop this from happening
PURPOSE This clinical trial is studying how well giving fludarabine alemtuzumab and total-body irradiation together with donor stem cell transplant and donor white blood cell WBC infusion works in treating patients with chronic phase chronic myelogenous leukemia CML that did not respond to previous imatinib mesylate
PURPOSE This clinical trial is studying how well giving fludarabine alemtuzumab and total-body irradiation together with donor stem cell transplant and donor white blood cell WBC infusion works in treating patients with chronic phase chronic myelogenous leukemia CML that did not respond to previous imatinib mesylate
Detailed Description:
OBJECTIVES
Determine the treatment-related mortality in patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia treated with nonmyeloablative conditioning comprising fludarabine alemtuzumab and total-body irradiation followed by T-cell-depleted allogeneic stem cell transplantation and post-transplantation allogeneic T-cell infusion
Determine if donor engraftment can be safely established using partial T-cell depletion with additional T-cell infusions in these patients
OUTLINE Patients receive alemtuzumab IV over 5-6 hours on day -8 and fludarabine IV on days -4 to -2 Patients undergo total-body irradiation followed by T-cell-depleted CD34 selected allogeneic stem cell transplantation on day 0 Patients receive allogeneic T-cell infusion on days 30 and 60 Patients also receive cyclosporine twice daily beginning on day -3 and continuing until day 100 followed by a taper until day 177
PROJECTED ACCRUAL Not specified
Determine the treatment-related mortality in patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia treated with nonmyeloablative conditioning comprising fludarabine alemtuzumab and total-body irradiation followed by T-cell-depleted allogeneic stem cell transplantation and post-transplantation allogeneic T-cell infusion
Determine if donor engraftment can be safely established using partial T-cell depletion with additional T-cell infusions in these patients
OUTLINE Patients receive alemtuzumab IV over 5-6 hours on day -8 and fludarabine IV on days -4 to -2 Patients undergo total-body irradiation followed by T-cell-depleted CD34 selected allogeneic stem cell transplantation on day 0 Patients receive allogeneic T-cell infusion on days 30 and 60 Patients also receive cyclosporine twice daily beginning on day -3 and continuing until day 100 followed by a taper until day 177
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| OHSU-414 | OTHER | OHSU IRB | None |
| OHSU-TPI-02032-L | OTHER | None | None |