Clinical Trial VICCHEM12103
Multi-center Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-Chop
- 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
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.
|Ages Eligible for Study:||18 Years to 120 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 1. Diagnosis of diffuse large B-cell lymphoma, CD20-positive, according to the World Health Organization Classification, stages II-IV or limited stage I disease that is bulky (more than 10 cm) or with International Prognostic Index (IPI) score > 1.
• 2. Patients must not have had prior chemotherapy, radiotherapy or immunotherapy. A short course (< 2 weeks) of corticosteroids is allowed.
• 3. Adequate paraffin-embedded tumor specimen must be available for gene expression analysis and immunohistochemistry prior to initiation of therapy. (If the specimen is deemed inadequate, the subject can be retroactively screen failed, as this does not change the treatment regimen).
• 4. Baseline measurements and evaluation must be obtained within 4 weeks before first treatment.
• 5. Age >18 years.
• 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
• 7. Adequate organ function:
• White Blood Cells count (WBC) >2500/µL
• Absolute Neutrophil Count (ANC) > 1000/µL (unless due to disease in marrow)
• platelet count >100,000/µL (unless due to disease in marrow)
• creatinine < 2.0 mg/dL,
• bilirubin < 1.5 mg/dL (may be 1.5-3.0 mg/dl if due to liver involvement by lymphoma)
• Serum Glutamic Oxaloacetic Transaminase (SGOT)/ Serum Glutamic Pyruvic Transaminase (SGPT) <3 x upper limit of normal.
• 8. Female patients must not be pregnant or breast feeding.
• 9. Women of childbearing potential and men must be strongly advised to use an accepted and effective method of contraception.
• 10. Patients must have left ventricular ejection fraction of >45%.
• 11. Provision of written informed consent.
• 1. Patients with a second malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix unless the tumor was treated with curative intent at least two years previously; and; the patient continue to be free of evidence of recurrence.
• 2. Patients with HIV infection as these patients are managed on dedicated protocols.
• 3. Patients with active central nervous system (CNS) lymphoma.