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

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ClinicalTrials.gov Identifier: NCT00590941

Recruitment Status : Completed

First Posted : January 11, 2008

Last Update Posted : May 16, 2013

Sponsor:

Information provided by (Responsible Party):

Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lymphoma Diffuse Large Cell	Procedure: Blood draw	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	52 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	Candidate Gene Polymorphisms and Response to Rituximab-CHOP in Patients With Diffuse Large Cell Lymphoma
Study Start Date :	February 2005
Actual Primary Completion Date :	July 2008
Actual Study Completion Date :	April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Diffuse Large B-Cell Lymphoma B-cell Lymphoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
No Intervention: 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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures :

Negative [F-18]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan after 2 cycles of R-CHOP [ Time Frame: Approximately 42 days (2 cycles of R-CHOP) ]

Secondary Outcome Measures :

Response after six cycles of R-CHOP [ Time Frame: Approximately 126 days (6 Cycles of R-CHOP) ]
Progression free survival [ Time Frame: 3 years ]
Grade 3-4 toxicity [ Time Frame: Approximately 156 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590941

Locations

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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

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Principal Investigator:	Amanda Cashen, MD	Washington University School of Medicine

More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00590941
Other Study ID Numbers:	05-0122 05-0122
First Posted:	January 11, 2008 Key Record Dates
Last Update Posted:	May 16, 2013
Last Verified:	May 2013

Keywords provided by Washington University School of Medicine:


Lymphoma Rituximab CHOP

Additional relevant MeSH terms:

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Lymphoma Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders	Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin

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