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Genetic Determinations for Side Effects and Response Rate for Patients Receiving Chemotherapy With Diffuse Large Cell Lymphoma

This study is currently recruiting participants.
Information provided by Washington University School of Medicine

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Descriptive Information Fields
Brief Title  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
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.

Study Phase
Study Type  Interventional
Study Design  Other, Randomized, Open Label, Single Group Assignment, Efficacy Study
Primary Outcome Measure  Negative [F-18]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan after 2 cycles of R-CHOP [ Time Frame: 2 cycles of R-CHOP ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Response after six cycles of R-CHOP [ Time Frame: 6 Cycles of R-CHOP ] [ Designated as safety issue: No ]
progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Grade 3-4 toxicity [ Time Frame: 6 cycles of R-CHOP ] [ Designated as safety issue: Yes ]
Condition  Lymphoma
Diffuse Large Cell
Intervention  Genetic: Blood draw
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
MEDLINE PMIDs 9166827,   791473,   7680764,   11208830,   11807147,   12531812,   12957239,   10586334,   11342337,   12196360,   10397709,   9616140,   12163626,   10870118,   10676951,   11840294,   14615382,   8547651
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  50
Start Date  February 2005
Completion Date February 2007
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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Amanda Cashen, MD     314-362-3515     acashen@im.wustl.edu    
Contact: Leslie Foster, MHA, BS     314-362-8547     fosterl@ccadmin.wustl.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00590941
Organization ID 05-0122
Secondary IDs †† 05-0122
Study Sponsor  Washington University School of Medicine
Collaborators †† BJC Foundation
Investigators 
Principal Investigator:     Amanda Cashen, MD     Washington University School of Medicine    
Information Provided By Washington University School of Medicine
Verification Date November 2007
First Received Date  December 28, 2007
Last Updated Date December 28, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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