Single-Arm, Open-Label, Phase II Trial of Rituximab Plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-Cell Lymphoma in Adults
- 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
- Determine the overall response rate in patients treated with this regimen.
- Determine the progression-free survival at 3 years in patients treated with this
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response at 3 months
Nathan Fowler, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|