Trial Information

An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-Tumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With Rituximab (MabThera®) in Patients With Follicular Non Hodgkin's Lymphoma With no Prior Treatment

OBJECTIVES:

Primary

- Evaluate the clinical efficacy of sargramostim (GM-CSF) and rituximab, in terms of
overall objective complete and partial response rates, in patients with previously
untreated follicular non-Hodgkin lymphoma.

Secondary

- Evaluate the time to progression in patients treated with this regimen.

- Evaluate the overall survival of patients treated with this regimen.

- Evaluate the duration of response in patients treated with this regimen.

- Evaluate the safety profile of this regimen in these patients.

- Evaluate the influence of FcγR polymorphisms on clinical response.

- Monitor FcγR-expressing cells in peripheral blood during treatment.

- Monitor the molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone
marrow.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days
1-5 and rituximab IV on day 1. Treatment repeats every 21 days for up to 8 courses in
the absence of disease progression or unacceptable toxicity.

- Maintenance therapy: Patients receive GM-CSF SC on days 1-5 and rituximab IV on day 1.
Treatment repeats every 8 weeks for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

Blood and bone marrow samples are collected at baseline and periodically during study for
analysis of bcl2 rearrangement by PCR assay; FcγR expression by immunophenotyping; and FcγR
polymorphisms.

After completion of study therapy, patients are followed every 3 months for 1 year and then
every 6 months for up to 4 years.