Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma
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.
Biological: Sargramostim (GM-CSF)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Complete response at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Progression-free survival at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: At 2 months, followed every 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Rituximab + GM-CSF
Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22.
Other Name: RituxanBiological: Sargramostim (GM-CSF)
250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
- 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.
- 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.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411086
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Nathan Fowler, MD||M.D. Anderson Cancer Center|