Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.