Genetic Determinations for Side Effects and Response Rate for Patients Receiving Chemotherapy With Diffuse Large Cell Lymphoma
NCT ID: NCT00590941
Last Updated: 2013-05-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
52 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-02-28
Study Completion Date
2011-04-30
Brief Summary
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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
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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.
Conditions
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Lymphoma
Diffuse Large Cell
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
SINGLE_GROUP
Blinding Strategy
NONE
Study Groups
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R-CHOP
Patients receiving R-CHOP via standard of care which consists of cyclophosphamide 750 mg/m2 IV day 1 of each 21 day cycle, doxorubicin 50 mg/m2 IV day 1 of each 21 day cycle, vincristine 1.4 mg/m2 IV day 1 of each 21 day cycle, prednisone 100 mg PO days 1-5 of each 21 day cycle, and rituximab 375 mg/m2 IV day 1 of each 21 day cycle.
Group Type
NO_INTERVENTION
Blood draw
Intervention Type
PROCEDURE
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.
Interventions
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Blood 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.
Intervention Type
PROCEDURE
Eligibility Criteria
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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.
* 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
* Known HIV positive
* T-cell lymphoma or history of indolent NHL
* Patients who will be treated with radiation therapy
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Amanda Cashen, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Countries
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United States
References
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Related Links
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http://www.siteman.wustl.edu
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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05-0122
Identifier Type: -
Identifier Source: secondary_id
05-0122
Identifier Type: -
Identifier Source: org_study_id
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