Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003663
Status:
WITHDRAWN
Last Update Posted:
2015-08-19
First Post:
1999-11-01
Brief Title:
Rituximab and Dexamethasone in Treating Patients With Recurrent or Refractory Indolent Non-Hodgkins Lymphoma
Sponsor:
Hoag Memorial Hospital Presbyterian
Organization:
Hoag Memorial Hospital Presbyterian
Study Overview
Official Title:
Rituximab Anti-CD20 Monoclonal Antibody and Dexamethasone in the Treatment of Relapsed Indolent Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no patient accrual
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 tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining the monoclonal antibody rituximab with dexamethasone may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of rituximab and dexamethasone in treating patients with recurrent or refractory indolent non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of rituximab and dexamethasone in treating patients with recurrent or refractory indolent non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the toxic effects of rituximab and dexamethasone in patients with recurrent or refractory indolent non-Hodgkins lymphoma II Determine the objective tumor response rate and duration of response at 2 months after initiation of therapy and the percentage of patients with progressive disease III Determine the maximum response duration of response and progression free interval for patients who have not progressed after 4 weeks of therapy IV Determine the failure-free and overall survival of these patients on this regimen V Compare the response rate and survival rates to results for similar patients historical and concurrent who have received 4 weeks of rituximab without dexamethasone and patients who did not receive maintenance rituximab
OUTLINE Patients receive dexamethasone IV followed by rituximab IV on days 1 8 15 and 22 for one course Two months after initiating treatment patients are evaluated for disease progression Patients with stable or responding disease may receive monthly dexamethasone and rituximab therapy for up to 10 additional months Patients are followed every 3 months for 2 years then every 6 months for years 3-4 and then yearly for up to 5 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study
OUTLINE Patients receive dexamethasone IV followed by rituximab IV on days 1 8 15 and 22 for one course Two months after initiating treatment patients are evaluated for disease progression Patients with stable or responding disease may receive monthly dexamethasone and rituximab therapy for up to 10 additional months Patients are followed every 3 months for 2 years then every 6 months for years 3-4 and then yearly for up to 5 years
PROJECTED ACCRUAL A total of 20-40 patients 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-V98-1492 | None | None | None |
| CBRG-9805 | None | None | None |