The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or by presence of biomarkers associated with the anti-tumor effects of Rituximab.
In this phase II multi-institutional trial, the investigators will identify genes associated with either good or bad outcome in DLBCL patients treated with R-CHOP, will construct a robust predictive models based on RNA extracted from or paraffin specimens as well on immunohistochemistry and will examine the predictive power of new biomarkers associated with the anti-tumor effects of rituximab. The acquisition of fixed tissue as a component of this uniformly treated prospective study will also afford future studies with this informative dataset.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles
Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles
Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles
Stanford University
Stanford, California, United States
University of Miami
Miami, Florida, United States
University of Rochester Medical Center - Wilmot Cancer Institute
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Determination of a List of Genes and Construction of Survival Prediction Models That Will Predict Overall Survival at 30 Months in DLBCL Patients Receiving R-CHOP Therapy.
The investigators aim to determine a list of genes and construct survival prediction model(s) that will predict the overall survival at 30 months in DLBCL patients prospectively treated with R-CHOP chemotherapy. Overall survival time will be calculated from the date of the diagnosis until death or last follow-up examination.
Time frame: 30 months
Usefulness of Biomarkers Associated With Anti-Tumor Effects of Rituximab in Predicting Overall Survival in DLBCL Patients Receiving R-CHOP Therapy
The investigators aim to determine the usefulness of biomarkers associated with the antitumor effects of rituximab (e.g. immunoglobulin GFc receptor genotypes, CD20 protein expression and gene expression profiles) to predict overall survival of DLBCL patients treated with R-CHOP therapy and followed for at least 24 months or until death.
Time frame: 24 Months
Comparison of the Ability of Constructed Survival Models to Predict Overall Survival in DLBCL Patients Receiving R-CHOP Therapy
The investigators will compare the ability of constructed survival models to predict survival in DLBCL patients receiving R-CHOP therapy
Time frame: 2 Years
Determination of the Ability of Models and/or Biomarkers Associated With Anti-Tumor Effects of Rituximab to Predict 24-month Time to Treatment Failure in DLBCL Patients Receiving R-CHOP Therapy
The investigators aim to determine the ability of the models and/or biomarkers associated with the anti-tumor effects of rituximab to predict 24-month time to treatment failure, defined as disease progression, death or initiation of new treatment.
Time frame: 24 Months
Overall Response Rate of Study Participants at the End of Protocol Therapy
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Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Rate of participants achieving complete response (CR), complete response/unconfirmed (CRu) partial response (PR) according to Non-Hodgkin's Lymphoma response criteria.
Time frame: Up to 8 cycles, about 24 weeks
Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies.
Number of participants from whom paraffin-embedded DLBCL tissue samples were collected for future studies.
Time frame: Baseline