Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003849
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Rituximab in Treating Patients With Non-Hodgkins Lymphoma or Hodgkins Disease
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of C2B8 in Patients With Asymptomatic CD20 B-Cell Follicular Small Cleaved Low-Grade Non-Hodgkins Lymphoma or Relapsed CD20 Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2016-07
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
PURPOSE Phase II trial to study the effectiveness of rituximab in treating patients who have non-Hodgkins lymphoma or Hodgkins disease
PURPOSE Phase II trial to study the effectiveness of rituximab in treating patients who have non-Hodgkins lymphoma or Hodgkins disease
Detailed Description:
OBJECTIVES I Determine the response rate complete or partial to rituximab in previously untreated patients with stage III or IV CD20 B-cell follicular small cleaved cell non-Hodgkins lymphoma II Determine the response rate complete or partial to rituximab in patients with relapsed CD20 Hodgkins disease III Determine the time to progression and time to chemotherapy in these patients after treatment with rituximab
OUTLINE Patients are stratified according to disease follicular small cleaved cell non-Hodgkins lymphoma vs relapsed Hodgkins disease Patients receive rituximab IV over 4-6 hours on day 1 weekly for 4 weeks Patients are followed at 1 3 6 9 and 12 months then every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL A total of 21-32 patients will be accrued for each arm of this study within 7-105 months
OUTLINE Patients are stratified according to disease follicular small cleaved cell non-Hodgkins lymphoma vs relapsed Hodgkins disease Patients receive rituximab IV over 4-6 hours on day 1 weekly for 4 weeks Patients are followed at 1 3 6 9 and 12 months then every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL A total of 21-32 patients will be accrued for each arm of this study within 7-105 months
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 |
|---|---|---|---|
| CDR0000067010 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02298 | REGISTRY | None | None |