Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006695
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2000-12-06
Brief Title:
Monoclonal Antibody Therapy Combination Chemotherapy and Peripheral Stem Cell Transplant in Non-Hodgkins Lymphoma
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
BEAM Plus Iodine-131 Anti-B1 Antibody and Autologous Hematopoietic Stem Cell Transplantation for Treatment of Recurrent Diffuse Large B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-08
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:
RATIONALE Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE This phase II trial is studying how well monoclonal antibody therapy chemotherapy and peripheral stem cell transplant work in treating patients with relapsed or refractory non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well monoclonal antibody therapy chemotherapy and peripheral stem cell transplant work in treating patients with relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the response rates and time to treatment failure in patients with relapsed or refractory non-Hodgkins lymphoma treated with iodine I 131 monoclonal antibody anti-B1 followed by high-dose carmustine etoposide cytarabine and melphalan BEAM and autologous peripheral blood stem cell transplantation APBSCT vs historical control patients treated with high-dose BEAM or carmustine etoposide cytarabine and cyclophosphamide and APBSCT
Determine the safety of this regimen in these patients
OUTLINE Autologous peripheral blood stem cells PBSC are harvested and selected for CD34 cells or granulocyte macrophage colony-forming units On day -19 patients receive unlabeled monoclonal antibody anti-B1 MOAB anti-B1 IV followed by a dosimetric dose of iodine I 131 MOAB anti-B1 IV over 20 minutes On day -12 patients receive unlabeled MOAB anti-B1 IV followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 20 minutes Patients then receive high-dose chemotherapy comprising carmustine IV on day -6 etoposide IV and cytarabine IV twice daily on days -5 to -2 and melphalan IV on day -1 Patients undergo autologous PBSC transplantation on day 0
Patients are followed at days 30 and 100 at 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study over 5 years
Compare the response rates and time to treatment failure in patients with relapsed or refractory non-Hodgkins lymphoma treated with iodine I 131 monoclonal antibody anti-B1 followed by high-dose carmustine etoposide cytarabine and melphalan BEAM and autologous peripheral blood stem cell transplantation APBSCT vs historical control patients treated with high-dose BEAM or carmustine etoposide cytarabine and cyclophosphamide and APBSCT
Determine the safety of this regimen in these patients
OUTLINE Autologous peripheral blood stem cells PBSC are harvested and selected for CD34 cells or granulocyte macrophage colony-forming units On day -19 patients receive unlabeled monoclonal antibody anti-B1 MOAB anti-B1 IV followed by a dosimetric dose of iodine I 131 MOAB anti-B1 IV over 20 minutes On day -12 patients receive unlabeled MOAB anti-B1 IV followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 20 minutes Patients then receive high-dose chemotherapy comprising carmustine IV on day -6 etoposide IV and cytarabine IV twice daily on days -5 to -2 and melphalan IV on day -1 Patients undergo autologous PBSC transplantation on day 0
Patients are followed at days 30 and 100 at 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study over 5 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 |
|---|---|---|---|
| COULTER-IND-3323 | OTHER_GRANT | Coulter Pharmaceuticals Inc | None |