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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000637112 | Registry Identifier | PDQ (Physician Data Query) | |
| EUDRACT-2007-005580-95 | |||
| RECF0906 |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | |||
| sargramostim | Biological | |||
| gene expression analysis | Genetic | |||
| gene rearrangement analysis | Genetic | |||
| polymerase chain reaction | Genetic | |||
| polymorphism analysis | Genetic | |||
| laboratory biomarker analysis | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Overall objective tumor response rate at the end of induction therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | ||
| Overall survival | ||
| Duration of response |
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DISEASE CHARACTERISTICS:
Histologically and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Francois Rossi, MD, PhD | Hopital Lapeyronie-CHU Montpellier | Principal Investigator |
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| 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 |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C081222 | sargramostim |
| D020869 | Gene Expression Profiling |
| D015321 | Gene Rearrangement |
| D016133 | Polymerase Chain Reaction |
| D054458 | Amplified Fragment Length Polymorphism Analysis |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D055614 | Genetic Phenomena |
| D021141 | Nucleic Acid Amplification Techniques |
| D016172 | DNA Fingerprinting |
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