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Candidate Gene Polymorphisms and Response to Rituximab-CHOP in Patients With Diffuse Large Cell Lymphoma


N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma, Diffuse Large Cell

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Trial Information

Candidate Gene Polymorphisms and Response to Rituximab-CHOP in Patients With Diffuse Large Cell Lymphoma


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Negative [F-18]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan after 2 cycles of R-CHOP

Outcome Time Frame:

Approximately 42 days (2 cycles of R-CHOP)

Safety Issue:

No

Principal Investigator

Amanda Cashen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

05-0122

NCT ID:

NCT00590941

Start Date:

February 2005

Completion Date:

April 2011

Related Keywords:

  • Lymphoma
  • Diffuse Large Cell
  • Lymphoma
  • Rituximab
  • CHOP
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110