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Clinical Trial VICCHEM12103

Title

Multi-center Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-Chop

Principal Investigator(s)

Nishitha Reddy

Details

  • Protocol No. VICCHEM12103
  • Open Date: 12/31/2013
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: 1 To determine a list of genes and construct a survival prediction model(s) that will predict the overall survival at 30 months in DLBCL patients prospectively treated with R-CHOP chemotherapy. 2 To determine the usefulness of biomarkers associated with the anti-tumor effects of rituximab (e.g. immunoglobulin G Fc receptor genotypes, CD 20 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. 3 To compare the ability of constructed survival models to predict survival in DLBCL.
  • Disease Sites: Lymphoma
  • Therapies: Chemotherapy - cytotoxic
  • Drugs: Cyclophosphamide (CTX); Doxorubicin; Prednisone; Rituxan; Rituximab (Rituxan); Vincristine
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT00450385
  • Secondary Protocol No: 20061138

Description

Patients with diffuse large B-cell lymphoma (DLBCL) who are receiving R-CHOP as part of their standard therapy are invited to take part in this study. R-CHOP (rituximab combined with cyclophosphamide, doxorubicin, vincristine and prednisone) is the current standard therapy for this disease. The purpose of this study is to try to identify genes that can predict outcomes of patients treated with R-CHOP. Patients have had or will have a tumor biopsy as part of their routine care. Tissue left over from the tumor biopsy will be used to analyze genes and correlate them with patient outcomes with standard therapy. Only tissue leftover from standard care tumor biopsies will be used for genetic testing; no extra tissue will be collected. The genetic testing done for this study may, in the future, allow doctors to identify patients who could benefit from this therapy or who may need more aggressive therapy up front. Presently such identification is not possible.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

DISEASE CHARACTERISTICS:
• Diagnosis of diffuse large B-cell lymphoma, meeting 1 of the following staging criteria:
• Limited stage I disease that is bulky (i.e., more than 10 cm) or with International Prognostic Index > 1
• Stage II-IV disease
• CD20-positive disease
• Paraffin-embedded tumor specimen must be available
• No active CNS lymphoma
PATIENT CHARACTERISTICS:
• ECOG performance status 0-3
• WBC > 2,500/mm³
• Absolute neutrophil count > 1,000/mm³ (unless due to disease in marrow)
• Platelet count > 100,000/mm³ (unless due to disease in marrow)
• Creatinine < 2.0 mg/dL
• Bilirubin < 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma)
• AST and ALT < 3 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• LVEF > 45%
• No HIV positivity
• No other malignancy except for basal cell carcinoma of the skin or in situ carcinoma of the cervix (unless the tumor was treated with curative intent ≥ 2 years ago and the patient continues to be free of evidence of recurrence)
PRIOR CONCURRENT THERAPY:
• No prior chemotherapy, radiotherapy, or immunotherapy
• A prior short course (i.e., < 2 weeks) of corticosteroids allowed