GM-CSF, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Follicular Non-Hodgkin Lymphoma
Recruitment status was Not yet recruiting
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.
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Genetic: gene expression analysis
Genetic: gene rearrangement analysis
Genetic: polymerase chain reaction
Other: R-CHOP regimen
Other: laboratory biomarker analysis
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Overall objective tumor response rate [ Designated as safety issue: No ]
- Time to treatment progression [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Time to next treatment [ Designated as safety issue: No ]
- Safety profile [ Designated as safety issue: Yes ]
- Influence of FcγR polymorphisms on clinical response and overall survival [ Designated as safety issue: No ]
- Monitoring of FcγR expressing cells during treatment [ Designated as safety issue: No ]
- Quantitative monitoring of the molecular biological marker bcl-2 in peripheral blood and bone marrow by PCR assay [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
- 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 PCR.
After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 4 years.