Clinical trial NCT00590941: Genetic Determinations for Side Effects and Response Rate for Patients Receiving Chemotherapy With Diffuse Large Cell Lymphoma
Official title: Candidate Gene Polymorphisms and Response to Rituximab-CHOP in Patients With Diffuse Large Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Diffuse Large Cell
Keywords: Lymphoma
Rituximab
CHOP
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Negative [F-18]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan after 2 cycles of R-CHOP
timeFrame: Approximately 42 days (2 cycles of R-CHOP)
Secondary outcomes:
measure: Response after six cycles of R-CHOP
timeFrame: Approximately 126 days (6 Cycles of R-CHOP)
measure: Progression free survival
timeFrame: 3 years
measure: Grade 3-4 toxicity
timeFrame: Approximately 156 days
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Amanda Cashen, MD
role: PRINCIPAL_INVESTIGATOR
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