An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Antitumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With RCHOP Chemotherapy and Rituximab (MabThera®) Maintenance in Patients With First-Line Advanced Follicular Non Hodgkin's Lymphoma
- 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.
- 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
After completion of study therapy, patients are followed every 3 months for 1 year and then
every 6 months for 4 years.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall objective tumor response rate
Jean-Francois Rossi, MD, PhD
Hopital Lapeyronie-CHU Montpellier