Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
French Innovative Leukemia Organisation
OBJECTIVES: Primary * To evaluate the overall objective tumor response rate (complete and partial response rates) in patients with previously untreated advanced follicular non-Hodgkin lymphoma treated with sargramostim (GM-CSF) and R-CHOP. Secondary * To evaluate the time to progression. * To evaluate the overall survival. * To evaluate the duration of response. * To evaluate the time to next treatment. * To evaluate the safety profile of GM-CSF in combination with R-CHOP. * To evaluate the influence of FcγR polymorphisms on clinical response. * To monitor FcγR expressing cells in peripheral blood during treatment. * To monitor the molecular biological marker bcl-2 \[t(14;18)\] in peripheral blood and bone marrow by quantitative PCR assay. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1 and oral prednisone on days 1-5. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) on days 2-6. Treatment repeats every 21 days for up to 6 courses. Patients then receive rituximab IV on day 1 and GM-CSF SC on days 1-5. Treatment with rituximab and GM-CSF repeats every 21 days for 2 courses. Patients achieving complete or partial response proceed to maintenance therapy. * Maintenance therapy: Patients receive rituximab IV on day 1 and GM-CSF SC on days 1-5. Treatment repeats every 2 months for 12 courses. Blood and bone marrow samples are collected at baseline and periodically during study for analysis of FcγR expression by immunophenotyping and bcl-2 rearrangement by quantitative PCR. After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
