Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411086
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2006-12-11
Brief Title:
Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Single-Arm Open-Label Phase II Trial of Rituximab Plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-Cell Lymphoma in Adults
Status:
COMPLETED
Status Verified Date:
2017-11
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 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 Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in bone marrow or peripheral blood Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma
PURPOSE This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma
PURPOSE This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and efficacy of rituximab and sargramostim GM-CSF in terms of complete response at 12 weeks in patients with newly diagnosed follicular B-cell lymphoma
Secondary
Determine the overall response rate in patients treated with this regimen
Determine the progression-free survival at 3 years in patients treated with this regimen
Determine the adverse event profile of this regimen in these patients
Determine the survival of patients treated with this regimen
Determine the effect of Fc gamma receptor polymorphism on response rate and time to progression in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive rituximab IV on days 1 8 15 and 22 and sargramostim GM-CSF subcutaneously on days 1 3 and 5 Treatment with GM-CSF repeats weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection at baseline for correlative laboratory studies of Fc-gamma receptor RIIIa 158 polymorphism
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 1 year
Primary
Determine the safety and efficacy of rituximab and sargramostim GM-CSF in terms of complete response at 12 weeks in patients with newly diagnosed follicular B-cell lymphoma
Secondary
Determine the overall response rate in patients treated with this regimen
Determine the progression-free survival at 3 years in patients treated with this regimen
Determine the adverse event profile of this regimen in these patients
Determine the survival of patients treated with this regimen
Determine the effect of Fc gamma receptor polymorphism on response rate and time to progression in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive rituximab IV on days 1 8 15 and 22 and sargramostim GM-CSF subcutaneously on days 1 3 and 5 Treatment with GM-CSF repeats weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity
Patients undergo blood collection at baseline for correlative laboratory studies of Fc-gamma receptor RIIIa 158 polymorphism
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 1 year
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-2009-00187 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-2006-0260 | OTHER | None | None |
| CDR0000521620 | REGISTRY | None | None |