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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. |
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| 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. |
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| 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 ] |
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| Condition † | Lymphoma Diffuse Large Cell |
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| Intervention † | Genetic: Blood draw Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone |
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| 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:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| 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 † |
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| Information Provided By | Washington University School of Medicine | ||||||||
| Verification Date | November 2007 | ||||||||
| First Received Date † | December 28, 2007 | ||||||||
| Last Updated Date | December 28, 2007 | ||||||||