NCT00896519

GM-CSF, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Follicular Non-Hodgkin Lymphoma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as GM-CSF, may cause the body to make more blood cells and help it recover from the side effects of rituximab and combination chemotherapy. PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab and combination chemotherapy works in treating patients with previously untreated advanced follicular non-Hodgkin lymphoma.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab
BIOLOGICAL	sargramostim
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
DRUG	prednisone
DRUG	vincristine sulfate
GENETIC	gene expression analysis
GENETIC	gene rearrangement analysis
GENETIC	polymerase chain reaction
OTHER	R-CHOP regimen
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-03-01
• First posted: 2009-05-11
• Last updated: 2013-08-02