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Genetic Determinations for Side Effects and Response Rate for Patients Receiving Chemotherapy With Diffuse Large Cell Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00590941   Information provided by Washington University School of Medicine
First Received: December 28, 2007   Last Updated: October 27, 2008   History of Changes

December 28, 2007
October 27, 2008
February 2005
July 2010   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00590941 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Genetic Determinations for Side Effects and Response Rate for Patients Receiving Chemotherapy With Diffuse Large Cell Lymphoma
Candidate Gene Polymorphisms and Response to Rituximab-CHOP in Patients With Diffuse Large Cell Lymphoma

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.

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.

 
Interventional
Other, Randomized, Open Label, Single Group Assignment, Efficacy Study
  • Lymphoma
  • Diffuse Large Cell
  • Genetic: Blood draw
  • Drug: Rituximab
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin
  • Drug: Vincristine
  • Drug: Prednisone
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
50
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00590941
Amanda Cashen, MD, Washington University School of Medicine
05-0122, 05-0122
Washington University School of Medicine
BJC Foundation
Principal Investigator: Amanda Cashen, MD Washington University School of Medicine
Washington University School of Medicine
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP