Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002554
Status:
COMPLETED
Last Update Posted:
2010-03-30
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia in Remission or First Relapse
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
RADIOLABELED BC8 ANTI-CD45 ANTIBODY COMBINED WITH BUSULFAN AND CYCLOPHOSPHAMIDE AS TREATMENT FOR ACUTE MYELOGENOUS LEUKEMIA IN FIRST OR SECOND REMISSION OR UNTREATED FIRST RELAPSE FOLLOWED BY HLA-IDENTICAL RELATED MARROW TRANSPLANTATION
Status:
COMPLETED
Status Verified Date:
2010-03
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:
RATIONALE Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Monoclonal antibody combined with a radioactive substance and given prior to bone marrow transplantation may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of radiolabeled monoclonal antibody given prior to bone marrow transplantation in treating patients with acute myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of radiolabeled monoclonal antibody given prior to bone marrow transplantation in treating patients with acute myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the overall and disease-free survival and toxicity associated with busulfancyclophosphamide BUCTX plus 131I-labeled BC8 antibody 131I-BC8 followed by an HLA-identical related marrow transplant in patients with acute myelogenous leukemia in first or second remission or untreated first relapse II Study factors that may influence the biodistribution of 131I-BC8 in this patient population including marrow cellularity the level of antigen expression by leukemic cells in relapsed patients and the degree of antigen saturation by antibody III Determine the efficacy of BUCTX in patients in first remission unable to receive radiolabeled antibody eg patients who are HAMA-positive those not tolerating antibody test infusion those with unfavorable antibody biodistribution or those for whom antibody is unavailable
OUTLINE Radioimmunotherapy plus 2-Drug Cytoreductive Chemotherapy followed by Bone Marrow Transplantation with as indicated CNS Therapy Iodine-131-labeled Monoclonal Antibody BC8 anti-CD45 131I-BC8 plus Busulfan BU NSC-750 Cyclophosphamide CTX NSC-26271 followed by Allogeneic Bone Marrow ABM with as indicated Intrathecal Methotrexate IT MTX NSC-740
PROJECTED ACCRUAL It is anticipated that 30 patients in first remission 30 patients in untreated first relapse and 15 patients in second remission will be accrued over 3 years
OUTLINE Radioimmunotherapy plus 2-Drug Cytoreductive Chemotherapy followed by Bone Marrow Transplantation with as indicated CNS Therapy Iodine-131-labeled Monoclonal Antibody BC8 anti-CD45 131I-BC8 plus Busulfan BU NSC-750 Cyclophosphamide CTX NSC-26271 followed by Allogeneic Bone Marrow ABM with as indicated Intrathecal Methotrexate IT MTX NSC-740
PROJECTED ACCRUAL It is anticipated that 30 patients in first remission 30 patients in untreated first relapse and 15 patients in second remission will be accrued over 3 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 |
|---|---|---|---|
| NCI-V94-0393 | Registry Identifier | PDQ | None |
| CDR0000063421 | REGISTRY | None | None |