Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003716
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Phase II Trial of Rituximab in Patients With B-Cell Lymphoproliferative Disorders Associated With Pharmacologic Immunosuppression
Status:
COMPLETED
Status Verified Date:
2022-05
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 such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of rituximab in treating patients who have lymphoproliferative disorder that is associated with immunosuppression therapy
PURPOSE Phase II trial to study the effectiveness of rituximab in treating patients who have lymphoproliferative disorder that is associated with immunosuppression therapy
Detailed Description:
OBJECTIVES I Evaluate the efficacy of rituximab in patients with B-cell lymphoproliferative disorders while under pharmacologic immune suppression for control of either allograft rejection or autoimmune disease II Evaluate the safety and direct toxicity of rituximab in this patient population including the potential for opportunistic infections III Evaluate the secondary consequences of rituximab therapy in this population including changes in the requirement for immunosuppressive drugs effects on graft rejection graft survival and severity of autoimmune disease
OUTLINE Patients receive rituximab IV over several hours Treatment repeats every week for 4 courses Patients are followed every month for 6 months and then every 3 months until relapse or 2 years
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study within 1 year
OUTLINE Patients receive rituximab IV over several hours Treatment repeats every week for 4 courses Patients are followed every month for 6 months and then every 3 months until relapse or 2 years
PROJECTED ACCRUAL A total of 15 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-V98-1508 | None | None | None |
| SUMC-03 | None | None | None |