Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003356
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
1999-11-01
Brief Title:
Rituximab Plus Interleukin-2 in Treating Patients With Lymphoma
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Phase II Study of Rituxan and IL-2 in Patients With Low Grade or Follicular B-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-10
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 Interleukin-2 may stimulate a persons white blood cells to kill cancer cells
PURPOSE Phase III trial to study the effectiveness of combining rituximab and interleukin-2 intreating patients who have low-grade mantle cell lymphoma or follicular lymphoma
PURPOSE Phase III trial to study the effectiveness of combining rituximab and interleukin-2 intreating patients who have low-grade mantle cell lymphoma or follicular lymphoma
Detailed Description:
OBJECTIVES I Determine the response rate in patients with low-grade mantle cell or follicular B-cell lymphoma treated with a combination of rituximab and low-dose interleukin-2 IL-2 II Determine the maximum tolerated dose of IL-2 when given in conjunction with rituximab in this patient population III Assess whether antibody dependent cellular cytotoxicity ADCC is enhanced by in vivo exposure to IL-2 and whether ADCC activity correlates with clinical response in these patients IV Assess the incidence of antirituximab antibody formation in these patients
OUTLINE Patients receive interleukin-2 IL-2 subcutaneously on days 1-5 and rituximab IV on day 3 Courses repeat weekly for up to 4 weeks in the absence of disease progression or unacceptable toxicity Patients are followed weekly for 4 weeks and then every 3 months for 1 year
PROJECTED ACCRUAL A total of 14-29 patients with low-gradefollicular lymphoma and 14-29 patients with mantle cell lymphoma will be accrued for this study within 2-5 years
OUTLINE Patients receive interleukin-2 IL-2 subcutaneously on days 1-5 and rituximab IV on day 3 Courses repeat weekly for up to 4 weeks in the absence of disease progression or unacceptable toxicity Patients are followed weekly for 4 weeks and then every 3 months for 1 year
PROJECTED ACCRUAL A total of 14-29 patients with low-gradefollicular lymphoma and 14-29 patients with mantle cell lymphoma will be accrued for this study within 2-5 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 |
|---|---|---|---|
| P30CA011198 | NIH | None | None |
| URCC-U4497 | None | None | None |
| NCI-G98-1442 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA011198 |