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CompletedNCT00590941Updated May 16, 2013

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

An interventional study of Blood draw in Lymphoma and Diffuse Large Cell, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-16.

Sponsored by Washington University School of Medicine · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lymphoma
  • Diffuse Large Cell

Keywords

  • Lymphoma
  • Rituximab
  • CHOP
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 52 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,764 studies on the registry; 270 are open to participants now.

Of its 325 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • CNS involvement
  • Known HIV positive
  • T-cell lymphoma or history of indolent NHL
  • Patients who will be treated with radiation therapy
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureBlood 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.

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Response after six cycles of R-CHOP

    Time frame: Approximately 126 days (6 Cycles of R-CHOP)

  2. Progression free survival

    Time frame: 3 years

  3. Grade 3-4 toxicity

    Time frame: Approximately 156 days

07

Study locations

1 site
  • Washington University School of Medicine
    St. Louis, Missouri 63110, United States
08

References and documents

Publications

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00590941
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Jan 11, 2008
Start date
Feb 2005
Primary completion
Jul 2008
Completion
Apr 2011
Last update
May 16, 2013

Study contacts

Amanda Cashen, MD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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