Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004040
Status:
WITHDRAWN
Last Update Posted:
2015-08-19
First Post:
1999-12-10
Brief Title:
Monoclonal Antibody Therapy or Biological Therapy in Treating Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma in Remission After Chemotherapy
Sponsor:
Hoag Memorial Hospital Presbyterian
Organization:
Hoag Memorial Hospital Presbyterian
Study Overview
Official Title:
Patients With Chronic Lymphocytic Leukemia or Multiple Myeloma Whose Disease Has Been Controlled With Chemotherapy Rituximab Anti-CD20 Monoclonal Antibody or Interferon Alpha 2-b as Maintenance Therapy
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no patient accruals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Biological therapies such as interferon alfa-2b use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase II trial to study the effectiveness of rituximab or interferon alfa-2b in treating patients who have chronic lymphocytic leukemia or multiple myeloma in remission
PURPOSE Phase II trial to study the effectiveness of rituximab or interferon alfa-2b in treating patients who have chronic lymphocytic leukemia or multiple myeloma in remission
Detailed Description:
OBJECTIVES I Determine the toxicity of rituximab or interferon alfa-2b maintenance therapy in patients with chronic lymphocytic leukemia or multiple myeloma in remission after chemotherapy II Determine the progression free survival failure free survival and overall survival of these patients from time of chemotherapy discontinuation to completion of maintenance therapy III Compare the survival rates of these patients to similar patients treated in published studies IV Determine the quality of life of these patients on these regimens
OUTLINE Patients enter one of two treatment arms Arm I Patients receive rituximab IV on days 1 8 15 and 22 for course 1 and then once a month for 11 months or until disease progression Arm II Patients receive subcutaneous interferon alfa-2b every other day three times per week for 12 months Quality of life is assessed monthly during therapy Patients are followed every 3 months for 1 year and then annually for up to 5 years
PROJECTED ACCRUAL A total of 60-80 patients 30-40 per disease type will be accrued for this study
OUTLINE Patients enter one of two treatment arms Arm I Patients receive rituximab IV on days 1 8 15 and 22 for course 1 and then once a month for 11 months or until disease progression Arm II Patients receive subcutaneous interferon alfa-2b every other day three times per week for 12 months Quality of life is assessed monthly during therapy Patients are followed every 3 months for 1 year and then annually for up to 5 years
PROJECTED ACCRUAL A total of 60-80 patients 30-40 per disease type will be accrued for this study
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-V98-1495 | None | None | None |
| CBRG-9806 | None | None | None |