Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008177
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2001-01-06
Brief Title:
Radiolabeled Monoclonal Antibody Therapy Fludarabine Phosphate and Low-Dose Total-Body Irradiation Followed by Donor Stem Cell Transplant and Immunosuppression Therapy in Treating Older Patients With Advanced Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase I Study Combining Escalating Doses of Radiolabeled BC8 Anti-CD45 Antibody With Fludarabine Low Dose TBI PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil to Establish Mixed or Full Donor Chimerism for Elderly Patients With Advanced Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2019-11
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 I trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine phosphate and low-dose total-body irradiation followed by donor stem cell transplant and immunosuppression therapy in treating older patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that cannot be controlled with treatment Radiolabeled monoclonal antibodies such as iodine I 131 monoclonal antibody BC8 can find cancer cells and carry cancer-killing substances to them Giving chemotherapy such as fludarabine phosphate and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal 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 The donated stem cells may also replace the patients immune cells and help destroy any remaining cancer cells Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving radiolabeled monoclonal antibody therapy together with fludarabine phosphate and total-body irradiation before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose of radiation delivered via 131I-BC8 antibody iodine I 131 monoclonal antibody BC8 when combined with the non-myeloablative regimen of fludarabine fludarabine phosphate 2 Gy total-body irradiation TBI cyclosporine CSPmycophenolate MMF in elderly patients with advanced acute myeloid leukemia AML or high risk myelodysplastic syndromes MDS
II To determine the rates of donor chimerism resulting from this combined preparative regimen and to correlate level of donor chimerism with estimated radiation doses delivered to hematopoietic tissues via antibody
III To determine within the limits of a phase I study disease response and duration of remission
IV To assess dose-limiting toxicity DLT at the estimated maximum tolerated dose MTD of 131I-BC8 24 Gy in order to gain more confidence that the DLT rate is acceptable at this level
OUTLINE This is a dose-escalation study of iodine I 131 monoclonal antibody BC8
CONDITIONING REGIMEN Patients receive iodine I 131 monoclonal antibody BC8 intravenously IV on day -12 and fludarabine phosphate IV on days -4 to -2 Patients undergo total-body irradiation on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell transplantation on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO or IV twice daily BID on days -3 to 56 with taper to day 80 for patients with a related donor OR days -3 to 100 with taper to day 177 for patients with an unrelated donor in the absence of graft-versus-host disease GVHD Patients also receive mycophenolate mofetil PO or IV thrice daily TID on days 0 to 27 for patients with a related donor OR on days 0 to 40 with taper to day 96 for patients with an unrelated donor in the absence of GVHD
After completion of study treatment patients are followed up at 6 9 and 12 months every 6 months for 1 year and then yearly thereafter
I To determine the maximum tolerated dose of radiation delivered via 131I-BC8 antibody iodine I 131 monoclonal antibody BC8 when combined with the non-myeloablative regimen of fludarabine fludarabine phosphate 2 Gy total-body irradiation TBI cyclosporine CSPmycophenolate MMF in elderly patients with advanced acute myeloid leukemia AML or high risk myelodysplastic syndromes MDS
II To determine the rates of donor chimerism resulting from this combined preparative regimen and to correlate level of donor chimerism with estimated radiation doses delivered to hematopoietic tissues via antibody
III To determine within the limits of a phase I study disease response and duration of remission
IV To assess dose-limiting toxicity DLT at the estimated maximum tolerated dose MTD of 131I-BC8 24 Gy in order to gain more confidence that the DLT rate is acceptable at this level
OUTLINE This is a dose-escalation study of iodine I 131 monoclonal antibody BC8
CONDITIONING REGIMEN Patients receive iodine I 131 monoclonal antibody BC8 intravenously IV on day -12 and fludarabine phosphate IV on days -4 to -2 Patients undergo total-body irradiation on day 0
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell transplantation on day 0
IMMUNOSUPPRESSION Patients receive cyclosporine orally PO or IV twice daily BID on days -3 to 56 with taper to day 80 for patients with a related donor OR days -3 to 100 with taper to day 177 for patients with an unrelated donor in the absence of graft-versus-host disease GVHD Patients also receive mycophenolate mofetil PO or IV thrice daily TID on days 0 to 27 for patients with a related donor OR on days 0 to 40 with taper to day 96 for patients with an unrelated donor in the absence of GVHD
After completion of study treatment patients are followed up at 6 9 and 12 months every 6 months for 1 year and then yearly 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 |
|---|---|---|---|
| P01CA044991 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP01CA044991 |
| NCI-2010-02046 | REGISTRY | None | None |
| 1432 | None | None | None |
| 143200 | OTHER | None | None |
| P30CA015704 | NIH | None | None |