GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

Sponsor

French Innovative Leukemia Organisation (Other)

Overall Status

Unknown status

CT.gov ID

NCT00893477

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief Summary

RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. 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. Giving GM-CSF together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: rituximab Biological: sargramostim Genetic: gene expression analysis Genetic: gene rearrangement analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: laboratory biomarker analysis	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Anticipated Primary Completion Date :

Mar 1, 2011

Outcome Measures

Primary Outcome Measures

Overall objective tumor response rate at the end of induction therapy []

Secondary Outcome Measures

Time to progression []
Overall survival []
Duration of response []
Time to next treatment []
Safety profile []
Influence of FcγR polymorphisms on clinical response and survival []
FcγR expression during study treatment []
Molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow as measured by PCR assay []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification
Grade 1-3a disease
Stage II-IV disease
Non-bulky disease
Must have undergone initial nodal biopsy within the past 4 months
At least 1 measurable lesion
Low tumor-burden, as defined by the following GELF criteria:
Nodal or extranodal tumor mass (diameter < 7 cm)
No systemic B symptoms
No increased LDH and β2 microglobulinemia
No substantial splenic enlargement
No serous effusion
No compression syndrome