Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244855
Status:
COMPLETED
Last Update Posted:
2017-05-22
First Post:
2005-10-25
Brief Title:
Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Rituximab and Dexamethasone in CD20 Positive Low Grade and Follicular Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This phase II trial studies the side effects and how well giving rituximab and dexamethasone together works in treating patients with low-grade non-Hodgkin lymphoma NHL Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Drugs used in chemotherapy such as dexamethasone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving rituximab together with dexamethasone may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To estimate clinical response rate RR at 3 and 6 months II To estimate Grade 2-4 -infusion-related toxicity
SECONDARY OBJECTIVES
I To evaluate laboratory parameters and correlate with clinical response including antibody dependent cell mediated cytotoxicity and effector cell phenotype analysis at baseline 4 weeks and three months
II To evaluate laboratory parameters and correlate with clinical response including soluble cluster of differentiation CD20 fragments or CD20-containing membrane fragments at baseline 4 weeks and 3 months
III To evaluate laboratory parameters and correlate with clinical response including phenotype analysis of CD16 and CD32 on natural killer NK cells
IV To evaluate laboratory parameters and correlate with clinical response including rituximab pharmacokinetic studies at baseline 4 weeks and 3 months
OUTLINE
Patients receive dexamethasone intravenously IV and rituximab IV once weekly Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 3 and 6 months
I To estimate clinical response rate RR at 3 and 6 months II To estimate Grade 2-4 -infusion-related toxicity
SECONDARY OBJECTIVES
I To evaluate laboratory parameters and correlate with clinical response including antibody dependent cell mediated cytotoxicity and effector cell phenotype analysis at baseline 4 weeks and three months
II To evaluate laboratory parameters and correlate with clinical response including soluble cluster of differentiation CD20 fragments or CD20-containing membrane fragments at baseline 4 weeks and 3 months
III To evaluate laboratory parameters and correlate with clinical response including phenotype analysis of CD16 and CD32 on natural killer NK cells
IV To evaluate laboratory parameters and correlate with clinical response including rituximab pharmacokinetic studies at baseline 4 weeks and 3 months
OUTLINE
Patients receive dexamethasone intravenously IV and rituximab IV once weekly Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 3 and 6 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 |
|---|---|---|---|
| NCI-2011-00576 | REGISTRY | CTRP Clinical Trial Reporting Program | None |