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

Purpose

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	Intervention
Lymphoma Diffuse Large Cell	Procedure: Blood draw

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Candidate Gene Polymorphisms and Response to Rituximab-CHOP in Patients With Diffuse Large Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response after six cycles of R-CHOP [ Time Frame: Approximately 126 days (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: Approximately 156 days ] [ Designated as safety issue: Yes ]

Enrollment:	52
Study Start Date:	February 2005
Study Completion Date:	April 2011
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590941

Locations

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

Sponsors and Collaborators

Washington University School of Medicine

Investigators

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

Publications:

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Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00590941 History of Changes
Other Study ID Numbers:	05-0122, 05-0122
Study First Received:	December 28, 2007
Last Updated:	May 14, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Lymphoma
Rituximab
CHOP

Additional relevant MeSH terms:

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

Lymphoma, B-Cell
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 19, 2013