Diffuse Large Cell, Lymphoma
Conditions
Keywords
Lymphoma, Rituximab, CHOP
Brief summary
The purpose of this study is to determine whether people have genes that make them more likely to respond to chemotherapy and/or have side effects from chemotherapy for diffuse large cell lymphoma.
Detailed description
Upon enrollment in the study, patients will have a blood sample collected for genotyping of the FCGR3A gene (immunoglobulin Fc G receptor IIIa), the ABCB1 gene (ATP Binding Cassette Beta 1; also called MDR1), and other candidate genes. Patients will be treated with R-CHOP for six cycles, which is standard therapy for advanced stage DLCL. Response will be monitored by an FDG-PET scan performed after 2 cycles of R-CHOP and restaging exams performed upon completion of chemotherapy. Gene polymorphisms will be analyzed to establish which polymorphisms predict response to R-CHOP.
Interventions
PROCEDUREBlood draw
Sample Collection for Genotyping prior to cycle 1 treatment of R-CHOP, if patient is enrolled after cycle 1, sample for genotyping should be collected prior to cycle 2.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven diffuse large B-cell non-Hodgkin's lymphoma according to the WHO classification, with measurable or evaluable disease * No prior therapy for NHL. Patient may be enrolled in this study after the first cycle of R-CHOP if all screening evaluations were performed prior to the first cycle of chemotherapy. * Ann Arbor stage 3 or 4 * Age greater than or equal to 18 years * Patient must give written informed consent. * A patient enrolled in another clinical trial may also enroll in this study if the other trial has an R-CHOP treatment arm and the patient is randomized to the R-CHOP only arm. Registration to this study must occur after randomization in the other trial.
Exclusion criteria
* CNS involvement * Known HIV positive * T-cell lymphoma or history of indolent NHL * Patients who will be treated with radiation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative [F-18]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan after 2 cycles of R-CHOP | Approximately 42 days (2 cycles of R-CHOP) |
Secondary
| Measure | Time frame |
|---|---|
| Response after six cycles of R-CHOP | Approximately 126 days (6 Cycles of R-CHOP) |
| Progression free survival | 3 years |
| Grade 3-4 toxicity | Approximately 156 days |
Countries
United States
Outcome results
None listed