Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005940
Status:
COMPLETED
Last Update Posted:
2017-08-30
First Post:
2000-07-05
Brief Title:
Radiolabeled BC8 Antibody Busulfan Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase II Study of Radiolabeled BC8 Anti-CD45 Antibody Combined With Busulfan and Cyclophosphamide as Treatment for Acute Myelogenous Leukemia in First Remission Followed by HLA-Identical Related Peripheral Blood Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2017-08
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 II trial studies how well iodine I 131 monoclonal antibody BC8 busulfan and cyclophosphamide followed by donor stem cell transplant works in treating patients with acute myeloid leukemia that has decreased or disappeared but the cancer may still be in the body Giving chemotherapy drugs such as busulfan and cyclophosphamide before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patients immune system from rejecting the donors stem cells Also radiolabeled monoclonal antibodies such as iodine I 131 monoclonal antibody BC8 can find cancer cells and carry cancer-killing substances to them without harming normal cells When the stem cells from a related donor that closely matches the patients blood are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy as measured by survival and disease-free survival and toxicity of a regimen of busulfan 16 mgkg and cyclophosphamide 120 mgkg plus 131I-labeled anti-cluster of differentiation CD 45 antibody iodine I 131 monoclonal antibody BC8 delivering a dose of 525 gray Gy to the normal organ receiving the highest dose in patients with acute myeloid leukemia AML in first remission receiving human leukocyte antigen HLA-identical related peripheral blood stem cell PBSC transplants
OUTLINE
RADIOLABELED ANTIBODY Patients receive iodine I 131 monoclonal antibody BC8 intravenously IV on day -13
CHEMOTHERAPY Patients receive busulfan orally PO every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2
TRANSPLANT Patients undergo allogeneic PBSC or bone marrow BM transplant on day 0
GRAFT-VS-HOST DISEASE PREVENTION Patients receive cyclosporine IV or PO every 12 hours on days -1 to 50 with a taper to day 180 Patients also receive methotrexate IV on days 1 3 6 and 11
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 efficacy as measured by survival and disease-free survival and toxicity of a regimen of busulfan 16 mgkg and cyclophosphamide 120 mgkg plus 131I-labeled anti-cluster of differentiation CD 45 antibody iodine I 131 monoclonal antibody BC8 delivering a dose of 525 gray Gy to the normal organ receiving the highest dose in patients with acute myeloid leukemia AML in first remission receiving human leukocyte antigen HLA-identical related peripheral blood stem cell PBSC transplants
OUTLINE
RADIOLABELED ANTIBODY Patients receive iodine I 131 monoclonal antibody BC8 intravenously IV on day -13
CHEMOTHERAPY Patients receive busulfan orally PO every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2
TRANSPLANT Patients undergo allogeneic PBSC or bone marrow BM transplant on day 0
GRAFT-VS-HOST DISEASE PREVENTION Patients receive cyclosporine IV or PO every 12 hours on days -1 to 50 with a taper to day 180 Patients also receive methotrexate IV on days 1 3 6 and 11
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-2013-01361 | REGISTRY | None | None |
| FHCRC-147000 | None | None | None |
| NCI-H00-0056 | None | None | None |
| 1470 | None | None | None |
| CDR0000067778 | None | None | None |
| 147000 | OTHER | None | None |
| P30CA015704 | NIH | None | None |